Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris

A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different Doses of a Novel Tetracycline Compared to Placebo in the Treatment of Facial Acne Vulgaris, Study PR-10411

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: 50 mg P005672-HCl; Drug: Placebo; Drug: 100 mg P005672-HCl

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Warner Chilcott Investigational Site
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Warner Chilcott Investigational Site
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Warner Chilcott Investigational Site
  • California
    • Los Angeles, California, United States, 90045
      • Warner Chilcott Investigational Site
    • San Diego, California, United States, 92123
      • Warner Chilcott Investigational Site
    • Santa Monica, California, United States, 90404
      • Warner Chilcott Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33761
      • Warner Chilcott Investigational Site
    • Coral Gables, Florida, United States, 33134
      • Warner Chilcott Investigational Site
    • Gainesville, Florida, United States, 32605
      • Warner Chilcott Investigational Site
    • Miami, Florida, United States, 33175
      • Warner Chilcott Investigational Site
    • Miramar, Florida, United States, 33027
      • Warner Chilcott Investigational Site
    • Pinellas Park, Florida, United States, 33781
      • Warner Chilcott Investigational Site
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Warner Chilcott Investigational Site
    • Chicago, Illinois, United States, 60611
      • Warner Chilcott Investigational Site
  • Indiana
    • Granger, Indiana, United States, 46530
      • Warner Chilcott Investigational Site
    • Indianapolis, Indiana, United States, 46256
      • Warner Chilcott Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Warner Chilcott Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Warner Chilcott Investigational Site
  • Minnesota
    • Fridley, Minnesota, United States, 44532
      • Warner Chilcott Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Warner Chilcott Investigational Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Warner Chilcott Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Warner Chilcott Investigational Site
  • New York
    • Rochester, New York, United States, 14623
      • Warner Chilcott Investigational Site
    • Rochester, New York, United States, 14609
      • Warner Chilcott Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Warner Chilcott Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • Warner Chilcott Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • Warner Chilcott Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Warner Chilcott Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Warner Chilcott Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Warner Chilcott Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Warner Chilcott Investigational Site
  • Texas
    • Arlington, Texas, United States, 76011
      • Warner Chilcott Investigational Site
    • Austin, Texas, United States, 78759
      • Warner Chilcott Investigational Site
    • Houston, Texas, United States, 77065
      • Warner Chilcott Investigational Site
    • Plano, Texas, United States, 75093
      • Warner Chilcott Investigational Site
    • San Antonio, Texas, United States, 78229
      • Warner Chilcott Investigational Site
  • Utah
    • Sandy, Utah, United States, 84070
      • Warner Chilcott Investigational Site
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Warner Chilcott Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• if women of child-bearing potential, have a negative urine pregnancy test
• Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
• Male or female, 12-45 years of age with body weight between 52 and 88 kg

• Diagnosis of acne vulgaris with:

  20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones)

• No more than 2 nodules on the face
• Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)

Exclusion Criteria:

• Dermatological condition of face or facial hair that could interfere with clinical evaluations subjects who have used the following medications (topical refers only to the facial area) will not be eligible:

Within 1 week prior to randomization:

• Medicated facial cleansers
• Topical acne treatments (other than those listed below)

Within 4 weeks prior to randomization:

• Topical retinoids
• Topical anti-inflammatories and corticosteroids
• Systemic antibiotics
• Systemic acne treatments

Within 12 weeks prior to randomization:

• Systemic retinoids
• Systemic corticosteroids
• Pseudomembranous colitis or antibiotic-associated colitis
• Hepatitis, liver damage or renal impairment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P005672-HCl approximately 0.75 mg/kg/day; One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks	Drug: 50 mg P005672-HCl; P005672-HCl administered as an oral capsule(s) once daily; Other Names: WC3035, Sarecycline; Drug: Placebo; Dose-matched Placebo capsule administered as an oral capsule(s) once daily; Other Names: Inactive
Experimental: P005672-HCl approximately 1.5 mg/kg/day; Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks	Drug: 50 mg P005672-HCl; P005672-HCl administered as an oral capsule(s) once daily; Other Names: WC3035, Sarecycline
Experimental: P005672-HCl approximately 3.0 mg/kg/day; Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks	Drug: 100 mg P005672-HCl; P005672-HCl administered as an oral capsule(s) once daily; Other Names: WC3035, Sarecycline
Placebo Comparator: Placebo; Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks	Drug: Placebo; Dose-matched Placebo capsule administered as an oral capsule(s) once daily; Other Names: Inactive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit		Baseline (Week 0) to Final Visit (Up to Week 12)
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit	The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.	Final Visit (Up to Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit		Baseline (Week 0) up to Week 12
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit		Baseline (Week 0) up to Week 12
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit		Baseline (Week 0) up to Week 12
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit		Baseline (Week 0) up to Week 12
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12	The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.	Baseline to Final Visit (Up to Week 12)

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Collaborators: Allergan
• Investigators: Study Director: Herman Ellman, MD, Warner Chilcott

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2012
• Primary Completion (Actual): November 16, 2012
• Study Completion (Actual): January 31, 2013

Study Registration Dates

• First Submitted: June 22, 2012
• First Submitted That Met QC Criteria: June 22, 2012
• First Posted (Estimate): June 26, 2012

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Dermatologic Agents; Anti-Bacterial Agents; Sarecycline
• Other Study ID Numbers: PR-10411