Finasteride Treatment of Severe Nodulocystic Acne

February 12, 2019 updated by: Elorac, Inc.

A Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study Evaluating the Efficacy and Safety of Once Weekly High Dose Oral Finasteride in the Treatment of Severe Nodulocystic Acne

Double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of once weekly, high dose oral finasteride compared to placebo for the treatment of severe nodulocystic acne in male subjects.

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.

Detailed Description

There will be 180 male subjects in this study. The study is composed of a Screening Period of up to 30 days during which inclusion / exclusion criteria will be reviewed, screening laboratory results will be obtained and medication washouts will be done as required. Subjects will complete the sexual function questionnaire and depression scale. A one day Baseline Period (Day 0), during which baseline assessments of acne lesion counts, physical examination and Investigator's Global Assessment Scale will be done. The Baseline Period will be followed by a 12-week randomized double-blind Treatment Period, in which subjects will be randomized into Finasteride 23.5 mg group, 33.5 mg group, or placebo group. During the Treatment Period, subjects will visit the study site Day 14, Day 28, and Day 56 for acne lesion counts and review of diaries, concomitant medications and adverse events. On Day 84 subjects will return to clinic for acne lesion counts and review of diaries, concomitant medications, adverse events and remaining study drug will be counted and collected. A physical exam and vital signs, Investigator Global Assessment, Subject Assessment of Efficacy, depression scale and sexual function questionnaire will be completed before the subject is discharged from the study.

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.
106

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 2

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
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Omni Dermatology, Inc.
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Burke Pharmaceutical Research
    • California
      • Beverly Hills, California, United States, 90210
        • Dr. Ronald Moy
      • Los Angeles, California, United States, 90036
        • Axis Clinical Trials
      • Tustin, California, United States, 92780
        • Orange County Research Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • Horizons Clinical Research Center, LLC.
    • Florida
      • Brandon, Florida, United States, 33511
        • MOORE Clinical Research, Inc.
      • Miami Lakes, Florida, United States, 33174
        • Advanced Medcial Research Institiute
      • Orange Park, Florida, United States, 32073
        • Park Avenue Dermatology
      • Sanford, Florida, United States, 32771
        • International Clinical Research
      • Sweetwater, Florida, United States, 33172
        • Lenus Research & Medical Group
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Dermatology Clinical Research, Inc.
      • Newnan, Georgia, United States, 30263
        • MedaPhase, Inc.
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials
    • Illinois
      • Buffalo Grove, Illinois, United States, 60089
        • Glazer Dermatology
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Oakbrook Terrace, Illinois, United States, 60181
        • Summit Dermatology
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group. LLC
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Hamzavi Dermatology
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch Clinical Trials
    • New York
      • New York, New York, United States, 10012
        • Greenwich Village Dermatology
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • UHCMC Skin Study Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Paddington Testing Co., Inc.
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Invocare Clinical Research Center

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
  2. Males 18 years to 35 years of age.
  3. Except for severe nodulocystic acne, subject is in generally good health.
  4. Ten (10) or more nodular lesions (facial and/or truncal).
  5. Weight between 40 and 110 kg.
  6. No significant disease or clinically significant finding in a physical examination.
  7. No clinically significant abnormal laboratory value.
  8. No clinically significant abnormal vital sign measurement.
  9. Subject is able to swallow pills.
  10. Subject agrees to use a medically acceptable form of barrier-method contraception (e.g. condoms with spermicide or abstinence).
  11. Subject is willing and able to cooperate to the extent required by the protocol.

Exclusion Criteria:

  1. Female subjects will be excluded from the study.
  2. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks.
  3. Subject with a wash out period from Baseline for topical treatment on the skin less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatment (2 weeks); Cosmetic procedures (1 week); Photodynamic therapy and laser therapy for acne (3 months).
  4. Subject with a washout period from Baseline for systemic treatment less than: Corticosteroids, antibiotics (4 weeks), spironolactone (3 months), other systemic acne treatments (6 months), cyproterone acetate (6 months), lithium, anticonvulsants, barbiturates, androgenic and anabolic steroids, testosterone, estrogen, anti-tuberculous drugs, cyclosporine, and azathioprine (6 months), surgical treatment of acne (12 months), finasteride or other 5α-reductase inhibitors (12 months). (Table 2)
  5. Subjects with current or history of prostatic disease including benign prostatic hypertrophy, or surgery on prostate.
  6. Known history or presence of any clinically significant unstable medical condition(s) which in the opinion of the investigator could pose a risk for the safety of the subject, e.g. diabetes, cardiovascular, liver or kidney disease.
  7. Subjects with any skin disease or other condition that might interfere with the evaluation of nodular acne.
  8. Known history or suspected carcinoma.
  9. Allergy to finasteride or any other ingredients in the study medications.
  10. Subjects with history in past 12 months of active addiction, abuse, misuse and/or dependence on drugs or alcohol.
  11. Use of investigational drug within 90 days prior to Day 1

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: Triple

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.
Active Comparator: Finasteride 23.5 mg tablets group
Finasteride 23.5mg tablets and large placebo tablets once per week
Drug: Placebo tablets
Drug: Finasteride 23.5 mg tablets
Active Comparator: Finasteride 33.5 mg tablets group
Finasteride 33.5 mg tablets and small placebo tablets once per week
Drug: Placebo tablets
Drug: Finasteride 33.5 mg tablets
Placebo Comparator: Placebo group
Large and small placebo tablets once per week
Drug: Placebo tablets

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
Acne Nodular Lesion Count
Time Frame: 12 Weeks
Change from Baseline to week 12 in the total number of nodular lesions
12 Weeks

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
Proportion of Subjects who achieve at least a 75% reduction in total number of nodular lesions
Time Frame: 12 Weeks
Change from Baseline to week 12 in the total number of nodular lesions
12 Weeks
Investigator's Global Assessment Scale of Acne Severity
Time Frame: 12 Weeks
Change from Baseline to week 12
12 Weeks
Non-Inferiority (NI) for non-nodulocystic inflammatory lesions
Time Frame: 12 Weeks
The NI bound will be larger of 10% reduction or a count of 4 lesions.
12 Weeks
Change in total number of nodular lesions.
Time Frame: 2, 4, and 8 weeks
Change from baseline to weeks 2, 4 and 8.
2, 4, and 8 weeks
Proportion of subjects with 2 category improvement on Investigator's Global Assessment Scale
Time Frame: 12 Weeks
Change from Baseline to week 12
12 Weeks

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.
Elorac, Inc.

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: Scott B. Phillips, MD, Elorac, Inc.

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

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.
July 1, 2015

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.
June 6, 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.
June 6, 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).
July 10, 2015

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.
July 16, 2015

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.
July 20, 2015

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.
February 12, 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.
February 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.
  • EL-1006-01-01

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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