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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06463925
Other study ID # LRP23014-2223CBCL059 Effaclar
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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