Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01880320
First received: June 14, 2013
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

The study hypothesis are based on the assumption that :

  • CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects
  • CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile

Condition Intervention Phase
Acne Vulgaris
Drug: CD0271 0.3% / CD1579 2.5%
Drug: CD0271 0.1% / CD1579 2.5%
Drug: Topical Gel Vehicle
Phase 3

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 Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Galderma R&D:

Primary Outcome Measures:
  • Composite success rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Success rate is defined as the percentage of subjects with an IGA of clear or almost clear (and therefore at least a 2-grade improvement


Secondary Outcome Measures:
  • Percent Changes in Inflammatory and Non-inflammatory Lesion Counts [ Time Frame: Week12 ] [ Designated as safety issue: No ]

Enrollment: 503
Study Start Date: July 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD0271 0.3% /CD1579 2.5% Gel
active arm
Drug: CD0271 0.3% / CD1579 2.5%
Active Comparator: CD0271 0.1% / CD1579 2.5%
Comparator arm
Drug: CD0271 0.1% / CD1579 2.5%
Placebo Comparator: Topical Gel Vehicle
Placebo arm
Drug: Topical Gel Vehicle

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, who is 12 years of age or older at Screening visit.
  2. Clinical diagnosis of acne vulgaris with facial involvement.
  3. An IGA of Moderate (3) or Severe (4) at Baseline visit.
  4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
  5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.

Exclusion Criteria:

  1. More than 2 acne nodules on the face at Baseline visit.
  2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
  3. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
  4. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
  5. The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
  6. Use of hormonal contraceptives solely for control of acne.
  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: NCT01880320

  Show 31 Study Locations
Sponsors and Collaborators
Galderma R&D
  More Information

No publications provided

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01880320     History of Changes
Other Study ID Numbers: RD.06.SPR.18240
Study First Received: June 14, 2013
Last Updated: May 26, 2014
Health Authority: United States: Food and Drug Administration
Canada: Public Health Agency of Canada
Russia: Ministry of Health of the Russian Federation

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

ClinicalTrials.gov processed this record on August 21, 2014