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

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: CD0271 0.3% / CD1579 2.5%; Drug: CD0271 0.1% / CD1579 2.5%; Drug: Topical Gel Vehicle

• Registration Number: NCT01880320
• Lead Sponsor: Galderma R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-18
• Study Start: 2013-07
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2016-03-07
• Results First Submitted QC: 2016-07-25
• Results First Posted: 2016-09-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-28
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.3% / CD1579 2.5%	active arm
CD0271 0.1% / CD1579 2.5%	CD0271 0.1% / CD1579 2.5%	Comparator arm
Topical Gel Vehicle	Topical Gel Vehicle	Placebo arm

Primary Outcome Measures

Name	Time	Method
Success Rate	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.
Changes From Baseline in Inflammatory Lesion Counts	Baseline - Week12
Changes From Baseline in Non-Inflammatory Lesion Counts	Baseline - Week 12

Trial Locations

Locations (5)

Galderma Investigational Site; 🇨🇦 Waterloo, Canada

Galderma Investigational site; 🇨🇦 Surrey, Canada

Galderma Investigationnal Site; 🇺🇸 Mobile, Alabama, United States

Galderma investigational Site; 🇺🇸 Hershey, Pennsylvania, United States

Galderma Investiogational Site; 🇨🇦 Montreal, Canada