Evaluation of Effaclar Duo+M on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk

Acne Clinical Trial

Official title:

Evaluation of Effaclar Duo+M on Inflammatory and Non-Inflammatory Lesions in Subjects With Mild to Moderate Acne on Face and Trunk (Back and Chest)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463925
• Other study ID #: LRP23014-2223CBCL059 Effaclar
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Cosmetique Active International
• Contact: Alessandro Nascimento
• Phone: +55 21 98726-2046
• Email: a.nascimento[@]cidp-cro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.

Description:

The study will be conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil3, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice.

Statistical methodology:

Quantitative variables, or those that can reasonably be treated as such, are summarized using the minimum, maximum, measures of central tendency such as the mean and median & measures of dispersion such as the standard deviation (SD). Qualitative variables are summarized in the form of counts and percentages.

Significance level:

The null hypothesis will generally be rejected if a p-value less than 0.05 (5% significance level) is produced by the statistical procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• phototype I to VI

• mild to moderate acne on the face and trunk

Exclusion Criteria:

• cutaneous pathology on the studied zone other than acne

• topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Other:
• acneic participants group
Application of Effaclar Duo+M to the face and trunk twice daily (morning and evening) after washing with the cleansing gel.

Locations

Country	Name	City	State
Brazil	CIDP Brasil	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy on total acne lesion count on face and trunk	The counting is performed by region (back, chest, face, total) and type of lesion (post-inflammatory hyperpigmentation, post-inflammatory erythema, scars, pustules, nodules, papules, closed comedones, open comedones.	from baseline to Day168
Secondary	Evaluation of the degree of severity of acne on the face	Evaluation performed thanks to the Global Evaluation Acne (GEA) scale on a 6-point score: from 0 (Clean. No lesions) to 5 (Very severe).	from baseline to Day168
Secondary	Evaluation of the degree of severity of acne on the trunk	Evaluation performed thanks to the Investigator Global Assessment (IGA) scale on a 6-point score: from 0 (Absent) to 5 (Very serious).	from baseline to Day168