Efficacy and Tolerance of Formula 609613 37 in Acneic Patients

NCT05469880 | Completed

• 1 other identifier: LRP09001-EFFACLAR DUO
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acne

Keywords

acne; lipohydroxyacid; salicylic acid; benzoyl peroxide; dermocosmetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• change in the lesion count

  from baseline to month 6

• change in the evaluation of skin sensitivity by the patient

  from baseline to month 6

• change in the evaluation of global tolerance by the patient

  from baseline to month 6

• change in the evaluation of the efficacy by the investigator and patient

  from baseline to month 6

• change in the evaluation of the global efficacy by the investigator

  from baseline to month 6

Study Arms (2)

moisturizing cream and 5% benzoyl peroxide gel

ACTIVE COMPARATOR

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

anti-acne face cream and 5% benzoyl peroxide gel

EXPERIMENTAL

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

Interventions

moisturizing cream and 5% benzoyl peroxide gel OTHER

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

moisturizing cream and 5% benzoyl peroxide gel

anti-acne face cream and 5% benzoyl peroxide gel OTHER

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

anti-acne face cream and 5% benzoyl peroxide gel

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cosmetique Active International: lead

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The creams are packaged in white tubes with specific labelling that does not allow to identify them. The 5% benzoyl peroxide tubes are delivered in commercial form.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 22, 2022
• Study Start: October 21, 2009
• Primary Completion: May 25, 2010
• Study Completion: May 25, 2010
• Last Updated: July 22, 2022

Record last verified: 2022-07