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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628549
First Posted: June 26, 2012
Last Update Posted: May 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Warner Chilcott
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628549


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

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01628549     History of Changes
Other Study ID Numbers: PR-10411
First Submitted: June 22, 2012
First Posted: June 26, 2012
Last Update Posted: May 1, 2015
Last Verified: April 2015

Keywords provided by Warner Chilcott:
acne

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