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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628549
• Other study ID #: PR-10411
• Status: Completed
• Phase: Phase 2
• Start date: June 30, 2012
• Est. completion date: January 31, 2013

Study information

• Verified date: January 2019
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: January 31, 2013
• Est. primary completion date: November 16, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• 50 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
• Placebo
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
• 100 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily

Locations

Country	Name	City	State
United States	Warner Chilcott Investigational Site	Albuquerque	New Mexico
United States	Warner Chilcott Investigational Site	Arlington	Texas
United States	Warner Chilcott Investigational Site	Arlington Heights	Illinois
United States	Warner Chilcott Investigational Site	Austin	Texas
United States	Warner Chilcott Investigational Site	Berlin	New Jersey
United States	Warner Chilcott Investigational Site	Boston	Massachusetts
United States	Warner Chilcott Investigational Site	Charlotte	North Carolina
United States	Warner Chilcott Investigational Site	Chicago	Illinois
United States	Warner Chilcott Investigational Site	Cincinnati	Ohio
United States	Warner Chilcott Investigational Site	Clearwater	Florida
United States	Warner Chilcott Investigational Site	Coral Gables	Florida
United States	Warner Chilcott Investigational Site	Fridley	Minnesota
United States	Warner Chilcott Investigational Site	Gainesville	Florida
United States	Warner Chilcott Investigational Site	Granger	Indiana
United States	Warner Chilcott Investigational Site	Greer	South Carolina
United States	Warner Chilcott Investigational Site	Hot Springs	Arkansas
United States	Warner Chilcott Investigational Site	Houston	Texas
United States	Warner Chilcott Investigational Site	Indianapolis	Indiana
United States	Warner Chilcott Investigational Site	Los Angeles	California
United States	Warner Chilcott Investigational Site	Louisville	Kentucky
United States	Warner Chilcott Investigational Site	Lynchburg	Virginia
United States	Warner Chilcott Investigational Site	Miami	Florida
United States	Warner Chilcott Investigational Site	Miramar	Florida
United States	Warner Chilcott Investigational Site	Mobile	Alabama
United States	Warner Chilcott Investigational Site	Philadelphia	Pennsylvania
United States	Warner Chilcott Investigational Site	Pinellas Park	Florida
United States	Warner Chilcott Investigational Site	Plano	Texas
United States	Warner Chilcott Investigational Site	Portland	Oregon
United States	Warner Chilcott Investigational Site	Rochester	New York
United States	Warner Chilcott Investigational Site	Rochester	New York
United States	Warner Chilcott Investigational Site	Saint Louis	Missouri
United States	Warner Chilcott Investigational Site	Salisbury	North Carolina
United States	Warner Chilcott Investigational Site	San Antonio	Texas
United States	Warner Chilcott Investigational Site	San Diego	California
United States	Warner Chilcott Investigational Site	Sandy	Utah
United States	Warner Chilcott Investigational Site	Santa Monica	California
United States	Warner Chilcott Investigational Site	Tucson	Arizona
United States	Warner Chilcott Investigational Site	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit		Baseline (Week 0) to Final Visit (Up to Week 12)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)