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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014