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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
50 mg P005672-HCl
Placebo
100 mg P005672-HCl
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

P005672-HCl approximately 0.75 mg/kg/day

P005672-HCl approximately 1.5 mg/kg/day

P005672-HCl approximately 3.0 mg/kg/day

Placebo

Arm Description

One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks

Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks

Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks

Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks

Outcomes

Primary Outcome Measures

The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
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.

Secondary Outcome Measures

The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
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.

Full Information

First Posted
June 22, 2012
Last Updated
January 31, 2019
Sponsor
Almirall, S.A.
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01628549
Brief Title
Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2012 (Actual)
Primary Completion Date
November 16, 2012 (Actual)
Study Completion Date
January 31, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P005672-HCl approximately 0.75 mg/kg/day
Arm Type
Experimental
Arm Description
One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks
Arm Title
P005672-HCl approximately 1.5 mg/kg/day
Arm Type
Experimental
Arm Description
Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks
Arm Title
P005672-HCl approximately 3.0 mg/kg/day
Arm Type
Experimental
Arm Description
Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
50 mg P005672-HCl
Other Intervention Name(s)
WC3035, Sarecycline
Intervention Description
P005672-HCl administered as an oral capsule(s) once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive
Intervention Description
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
Intervention Type
Drug
Intervention Name(s)
100 mg P005672-HCl
Other Intervention Name(s)
WC3035, Sarecycline
Intervention Description
P005672-HCl administered as an oral capsule(s) once daily
Primary Outcome Measure Information:
Title
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
Time Frame
Baseline (Week 0) to Final Visit (Up to Week 12)
Title
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
Description
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.
Time Frame
Final Visit (Up to Week 12)
Secondary Outcome Measure Information:
Title
The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit
Time Frame
Baseline (Week 0) up to Week 12
Title
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time Frame
Baseline (Week 0) up to Week 12
Title
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time Frame
Baseline (Week 0) up to Week 12
Title
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time Frame
Baseline (Week 0) up to Week 12
Title
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12
Description
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.
Time Frame
Baseline to Final Visit (Up to Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herman Ellman, MD
Organizational Affiliation
Warner Chilcott
Official's Role
Study Director
Facility Information:
Facility Name
Warner Chilcott Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Granger
State/Province
Indiana
ZIP/Postal Code
46530
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
44532
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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