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OpenTrials
Completed

NCT Number: NCT01880320

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

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

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma Investigational Site, Barrie, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • More than 2 acne nodules on the face at Baseline visit.
  • Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
  • 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.
  • The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
  • The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
  • Use of hormonal contraceptives solely for control of acne.

Treatment and study plan

CD0271 0.3% / CD1579 2.5%

Drug

CD0271 0.1% / CD1579 2.5%

Drug

Topical Gel Vehicle

Drug

Primary outcomes

  1. Success Rate

    Time frame: Week 12

    Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA).

    Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.

  2. Changes From Baseline in Inflammatory Lesion Counts

    Time frame: Baseline - Week12

  3. Changes From Baseline in Non-Inflammatory Lesion Counts

    Time frame: Baseline - Week 12

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 18, 2013
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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