Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of P005672 in Treatment of Facial Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01628549
First received: June 22, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
Drug: 50 mg P005672
Drug: Placebo
Drug: 100 mg P005672
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different Doses of P005672 Compared to Placebo in the Treatment of Facial Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Inflammatory Lesion Count, Absolute Change from Baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Sum of inflammatory lesions (nodules [palpable solid lesion > 0.5 cm with depth, not necessarily elevated], papule [ solid, elevated lesion <0.5 cm] & pustules [elevated lesion containing pus < 0.5 cm]) found on the forehead, left & right cheeks, nose and chin

  • Dichotomized IGA (Investigator's Global Assessment) Score, Change from Baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    IGA Scale 0/clear-clear skin no inflammatory or noninflammatory lesions, 1/almost clear-rare noninflammatory lesions, no more than 1 small inflammatory lesion, 2/mild->than 1 with some noninflammatory lesions, no more than a few inflammatory lesions [papules/pustules only, no nodular lesions], 3/moderate->2, up to many noninflammatory lesions & may have some inflammatory lesions,no more than 1 small nodular lesion, 4/severe- >3, up to many noninflammatory & noninflammatory lesions, but no more than a few nodular lesions.


Secondary Outcome Measures:
  • Inflammatory Lesion Count, Percent Change from Baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Sum of inflammatory lesions on the forehead, left & right cheeks, nose and chin. Calculated as Baseline value minus post-Baseline value divided by Baseline value, expressed as a percentage.

  • Noninflammatory Lesion Count, Percent Change from Baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Sum of non-inflammatory lesions (open [blackhead] & closed [whitehead] comedones) found on the forehead, left & right cheeks, nose and chin. Calculated as Baseline value minus post-Baseline value divided by Baseline value, expressed as a percentage.

  • Noninflammatory Lesion Count, Absolute Change from Baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Sum of non-inflammatory lesions on the forehead, left & right cheeks, nose and chin. Calculated as Baseline value minus post-Baseline value.


Enrollment: 285
Study Start Date: June 2012
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg P005672
1 50 mg capsule P005672 and 1 matching placebo capsule, 1 capsule from each bottle taken orally each day
Drug: 50 mg P005672
50 mg P0005672 taken daily for 84 days at doses achieving 0.75 or 1.5 mg/kg daily treatment
Other Name: WC3035
Drug: Placebo
placebo capsule matching 50 mg or 100 mg capsules of P0005672 taken daily for 84 days
Other Name: Inactive
Experimental: 100 mg P005672
Two 50 mg capsules, 1 capsule from each bottle taken orally each day
Drug: 50 mg P005672
50 mg P0005672 taken daily for 84 days at doses achieving 0.75 or 1.5 mg/kg daily treatment
Other Name: WC3035
Experimental: 200 mg P005672
Two 100 mg capsules, 1 capsule from each bottle taken orally each day
Drug: 100 mg P005672
100 mg P0005672 taken daily for 84 days a dose achieving 3.0 mg/kg daily treatment
Other Name: WC3035
Placebo Comparator: Placebo
2 placebo capsules matching WC3035, 1 capsule from each bottle taken orally each day
Drug: Placebo
placebo capsule matching 50 mg or 100 mg capsules of P0005672 taken daily for 84 days
Other Name: Inactive

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 & 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
  • prolonged QTcF(>450msec) on Baseline ECG
  • pseudomembranous colitis or antibiotic-associated colitis
  • hepatitis, liver damage or renal impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628549

  Show 38 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Warner Chilcott
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01628549     History of Changes
Other Study ID Numbers: PR-10411
Study First Received: June 22, 2012
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on April 15, 2014