Clinical trial NCT01628549: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: acne
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Allergan
First posted: 2012-06-26
Enrollment: 285
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
timeFrame: Baseline (Week 0) to Final Visit (Up to Week 12)
measure: The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
timeFrame: Final Visit (Up to Week 12)
Secondary outcomes:
measure: The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit
timeFrame: Baseline (Week 0) up to Week 12
measure: The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
timeFrame: Baseline (Week 0) up to Week 12
measure: The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
timeFrame: Baseline (Week 0) up to Week 12
measure: The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
timeFrame: Baseline (Week 0) up to Week 12
measure: The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline to Final Visit (Up to Week 12)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Warner Chilcott Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: Warner Chilcott Investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Santa Monica
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Clearwater
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miramar
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Arlington Heights
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Granger
country: United States
facility: Warner Chilcott Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Warner Chilcott Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: Boston
country: United States
facility: Warner Chilcott Investigational Site
state: Massachusetts
city: Fridley
country: United States
facility: Warner Chilcott Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: Warner Chilcott Investigational Site
state: Missouri
city: Berlin
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Warner Chilcott Investigational Site
state: New Mexico
city: Rochester
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Rochester
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Charlotte
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Portland
country: United States
facility: Warner Chilcott Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Arlington
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Austin
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Houston
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Plano
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Sandy
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Lynchburg
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
Study officials:
affiliation: Warner Chilcott
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References: