Efficacy and Tolerance of Formula 609613 37 in Acneic Patients

Evaluation of the Efficacy and Tolerance of Formula 609613 37 in Acneic Patients as an Adjunct to and in Addition to 5% Benzoyl Peroxide for 6 Months

Acne affects most adolescents and young adults with varying severity and presentation. For early or localized forms, the first-line treatment is usually local. The available treatments often lead to local irritation, particularly during the first few weeks of use. This is why creams containing exfoliating agents have long been used in acne, as they are considered to allow a faster disappearance of superficial lesions.

The objective of this 6-month double-blind study is to demonstrate in 100 acneic patients the interest of an anti-acne face cream as an adjunct to and in addition to a 5% benzoyl peroxide gel.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Other: moisturizing cream and 5% benzoyl peroxide gel; Other: anti-acne face cream and 5% benzoyl peroxide gel

Detailed Description

The study is conducted in accordance with the protocol and the legislative and regulatory provisions in force (after obtaining authorization of the French health authorities and the favorable opinion of the ethics committee).

Regarding the statistical analysis, two different analysis are performed:

• Descriptive analysis: quantitative variables are described by the mean and standard deviation and qualitative variables by the raw number of each modality and the corresponding percentage.
• Comparative analysis: for quantitative variables, inter-group comparisons are made by a Student's T-test or a non parametric Mann-Whitney test if necessary. For qualitative variables, comparisons are made using a Chi-square test, if the expected number of participants is less than 5, Fischer's exact test on a 4-box contingency tables is used.

A significant level of p <0.05 is considered as significant. A double-data entry is carried out then a comparison of the two databases is performed. Finally internal and external consistency tests are planned. Missing data are described and possibly analyzed.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• acneic facial skin
• between 20 and 50 non-inflammatory lesions on the face
• between 10 and 40 superficial inflammatory lesions on the face
• no local acneic treatment in the previous 15 days
• no treatment with isotretinoin in the previous 3 months
• agreeing to apply only the study products

Exclusion Criteria:

• less than 20 or more than 50 non-inflammatory lesions on the face
• less than 10 or more than 40 superficial inflammatory lesions on the face
• prescription of a local acne treatment for less than 15 days
• prescription of an antibiotic treatment for less than 1 month
• prescription of an isotretinoin treatment for less than 3 months
• changing toiletries and hygiene products regularly

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: moisturizing cream and 5% benzoyl peroxide gel; Participants apply the 5% benzoyl peroxide gel every evening and the moisturizing cream every morning for 3 months. Then they are divided into 2 groups: one applies the anti-acne face cream every morning for 3 months and the other one the moisturizing cream every morning for 3 months.	Other: moisturizing cream and 5% benzoyl peroxide gel; Group A: Eclaran 5% every evening and formula 609567 49 every morning, for 3 months. Then the group is divided: Group A1/ formula 609613 37 and Group A2/ formula 609567 49 every morning, for the next 3 months
Experimental: anti-acne face cream and 5% benzoyl peroxide gel; Participants apply the 5% benzoyl peroxide gel every other night and the anti-acne face cream every morning for 3 months. Then they are divided into 2 groups: one applies the anti-acne face cream every morning for 3 months and the other one the moisturizing cream every morning for 3 months.	Other: anti-acne face cream and 5% benzoyl peroxide gel; Group B: Eclaran 5% every other night and 609613 37 every morning, for 3 months. Then the group is divided: Group B1/ 609613 37 and Group B2/ formula 609567 49 every morning, for the next 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the composite score	the investigator evaluates i) the skin sensitivity (erythema, desquamation) and ii) the global tolerance on a 4-point scale (i) from Absent to Important and ii) from Nil to Excellent)	from baseline to month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the lesion count	counting of non-inflammatory (open and closed comedones) and inflammatory (papules, pustules) lesions	from baseline to month 6
change in the evaluation of skin sensitivity by the patient	evaluation of the skin sensitivity (pruritus, tingling sensation, burning sensation) on a 4-point scale (from Absent to Important)	from baseline to month 6
change in the evaluation of global tolerance by the patient	evaluation on a 4-point scale (from Nil to Excellent)	from baseline to month 6
change in the evaluation of the efficacy by the investigator and patient	evaluation on a 4-point scale (from Nil to Excellent)	from baseline to month 6
change in the evaluation of the global efficacy by the investigator	evaluation on a 6-point scale (from No lesion to Very severe)	from baseline to month 6
change in the quality of life	evaluation of the quality of life of patients with the Cardiff Acne Disability Index (CADI) score	from baseline to month 6

Collaborators and Investigators

• Sponsor: Cosmetique Active International

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2009
• Primary Completion (Actual): May 25, 2010
• Study Completion (Actual): May 25, 2010

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: acne; benzoyl peroxide; dermocosmetic; salicylic acid; lipohydroxyacid
• Additional Relevant MeSH Terms: Dermatologic Agents; Benzoyl Peroxide
• Other Study ID Numbers: LRP09001-EFFACLAR DUO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No