Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

January 31, 2019 updated by: Almirall, S.A.

A Randomized, Multicenter, Double-blind, Placebocontrolled Study to Evaluate the Efficacy and Safety of 1.5 mg/kg Per Day of Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris

To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
968

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Warner Chilcott Research Site (Site #155)
      • Encino, California, United States, 91436
        • Warner Chilcott Research Site (Site #129)
      • La Mesa, California, United States, 91942
        • Warner Chilcott Research Site (Site #150)
      • Los Angeles, California, United States, 90045
        • Warner Chilcott Research Site (Site #136)
      • Sacramento, California, United States, 95819
        • Warner Chilcott Research Site (Site #147)
      • San Diego, California, United States, 92117
        • Warner Chilcott Research Site (Site #123)
      • San Diego, California, United States, 92123
        • Warner Chilcott Research Site (Site #125)
      • Santa Rosa, California, United States, 95403
        • Warner Chilcott Research Site (Site #139)
      • Tustin, California, United States, 92780
        • Warner Chilcott Research Site (Site #157)
    • Colorado
      • Denver, Colorado, United States, 80209
        • Warner Chilcott Research Site (Site #122)
      • Wheat Ridge, Colorado, United States, 80033
        • Warner Chilcott Research Site (Site #148)
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Warner Chilcott Research Site (Site #133)
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Warner Chilcott Research Site (Site #130)
      • Boynton Beach, Florida, United States, 33437
        • Warner Chilcott Research Site (Site #152)
      • Miami, Florida, United States, 33025
        • Warner Chilcott Research Site (Site #102)
      • Miami, Florida, United States, 33175
        • Warner Chilcott Research Site (Site #145)
      • North Miami Beach, Florida, United States, 33162
        • Warner Chilcott Research Site (Site #140)
      • Orange Park, Florida, United States, 32073
        • Warner Chilcott Research Site (Site #151)
      • Sanford, Florida, United States, 32771
        • Warner Chilcott Research Site (Site #108)
      • West Palm Beach, Florida, United States, 33409
        • Warner Chilcott Research Site (Site #110)
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Warner Chilcott Research Site (Site #154)
      • Augusta, Georgia, United States, 30909
        • Warner Chilcott Research Site (Site #120)
    • Idaho
      • Boise, Idaho, United States, 83704
        • Warner Chilcott Research Site (Site #124)
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Warner Chilcott Research Site (Site #106)
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Warner Chilcott Research Site (Site #112)
      • South Bend, Indiana, United States, 46617
        • Warner Chilcott Research Site (Site #113)
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Warner Chilcott Research Site (Site #117)
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Warner Chilcott Research Site (Site #135)
      • Metairie, Louisiana, United States, 70006
        • Warner Chilcott Research Site (Site #153)
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Warner Chilcott Research Site (Site #137)
      • Warren, Michigan, United States, 48088
        • Warner Chilcott Research Site (Site #111)
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Warner Chilcott Research Site (Site #119)
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Warner Chilcott Research Site (Site #138)
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Warner Chilcott Research Site (Site #103)
    • New Jersey
      • Verona, New Jersey, United States, 07044
        • Warner Chilcott Research Site (Site #127)
    • New York
      • New York, New York, United States, 10016
        • Warner Chilcott Research Site (Site #146)
      • New York, New York, United States, 10075
        • Warner Chilcott Research Site (Site #132)
      • Smithtown, New York, United States, 11787
        • Warner Chilcott Research Site (Site #134)
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Warner Chilcott Research Site (Site #107)
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Warner Chilcott Research Site (Site #126)
      • Warren, Ohio, United States, 44483
        • Warner Chilcott Research Site (Site #143)
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Warner Chilcott Research Site (Site #149)
      • Portland, Oregon, United States, 97210
        • Warner Chilcott Research Site (Site #131)
    • South Carolina
      • Greer, South Carolina, United States, 29650
        • Warner Chilcott Research Site (Site #114)
    • Tennessee
      • Knoxville, Tennessee, United States, 37917
        • Warner Chilcott Research Site (Site #128)
      • Nashville, Tennessee, United States, 37215
        • Warner Chilcott Research Site (Site #109)
    • Texas
      • Austin, Texas, United States, 78759
        • Warner Chilcott Research Site (Site #116)
      • Dallas, Texas, United States, 75234
        • Warner Chilcott Research Site (Site #104)
      • El Paso, Texas, United States, 79902
        • Warner Chilcott Research Site (Site #115)
      • Houston, Texas, United States, 77004
        • Warner Chilcott Research Site (Site #142)
      • Houston, Texas, United States, 77056
        • Warner Chilcott Research Site (Site #105)
      • Plano, Texas, United States, 75093
        • Warner Chilcott Research Site (Site #101)
      • San Antonio, Texas, United States, 78229
        • Warner Chilcott Research Site (Site #118)
    • Utah
      • Layton, Utah, United States, 84041
        • Warner Chilcott Research Site (Site #156)
      • Salt Lake City, Utah, United States, 84117
        • Warner Chilcott Research Site (Site #141)
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Warner Chilcott Research Site (Site #121)
    • Washington
      • Spokane, Washington, United States, 99204
        • Warner Chilcott Research Site (Site #144)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent or assent form
  • Male/female, 9 to 45 years of age, inclusive
  • Body weight between 33 and 136 kg, inclusive
  • Facial acne vulgaris with:
  • 20-50 inflammatory lesions (papules, pustules and nodules) 30-100 noninflammatory lesions (open and closed comedones)
  • No more than 2 nodules
  • IGA score of moderate (3) or severe (4)
  • Negative urine pregnancy test at baseline - females of childbearing potential
  • Agrees to use an effective method of contraception throughout the study
  • Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study
  • Able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (PHI)

Exclusion Criteria:

  • Has a dermatological condition of the face that could interfere with the clinical evaluations
  • Has a history of any of the following:
  • Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
  • Pseudomembranous colitis or antibiotic associated colitis
  • Treated for any type of cancer within the last 6 months
  • Has known resistance to other tetracyclines
  • Has received any of the following treatments within 12 weeks of screening:
  • Systemic retinoids
  • Systemic corticosteroids
  • Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone)
  • Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear)
  • Has used any acne affecting treatment without an appropriate washout period
  • Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period
  • Is pregnant, lactating or planning a pregnancy during the study period
  • Has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, Cushings disease or congenital adrenal hyperplasia
  • Has drug-induced acne
  • Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
  • Is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study
  • Has previously participated in any clinical trial involving the use of sarecycline
  • Is judged by the Investigator to be unsuitable for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sarecycline
Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.
Drug: Sarecycline
1.5 mg/kg/day taken orally at the same time each day,
Placebo Comparator: Placebo
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Drug: Placebo
Placebo-matching sarecycline tablets taken orally at the same time each day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute Change in Facial Inflammatory Lesion Counts at Week 12
Time Frame: Baseline (Day 1) to Week 12
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on Analysis of Covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 12
Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12
Time Frame: Baseline (Day 1) to Week 12
The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported.
Baseline (Day 1) to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
Time Frame: Baseline (Day 1) to Week 12
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 12
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
Time Frame: Baseline (Day 1) to Week 9
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 9
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
Time Frame: Baseline (Day 1) to Week 6
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 6
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
Time Frame: Baseline (Day 1) to Week 3
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 3
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
Time Frame: Baseline (Day 1) to Week 9
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 9
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
Time Frame: Baseline (Day 1) to Weeks 6
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Weeks 6
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
Time Frame: Baseline (Day 1) to Week 3
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 3
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12
Time Frame: Baseline (Day 1) to Week 12
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 12
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9
Time Frame: Baseline (Day 1) to Week 9
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 9
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6
Time Frame: Baseline (Day 1) to Week 6
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 6
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3
Time Frame: Baseline (Day 1) to Week 3
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 3
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12
Time Frame: Baseline (Day 1) to Week 12
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 12
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9
Time Frame: Baseline (Day 1) to Week 9
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 9
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6
Time Frame: Baseline (Day 1) to Week 6
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 6
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3
Time Frame: Baseline (Day 1) to Week 3
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Baseline (Day 1) to Week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Almirall, S.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alexandre Kaoukhov, MD, Warner Chilcott, an Affiliate of Allergan plc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SC1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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