An interventional study of Effaclar serum in Acne Vulgaris, sponsored by Cosmetique Active International. Completed at 1 site in France. Open to female participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-14.
Sponsored by Cosmetique Active International (part of L'Oréal) · Not applicable, Interventional, and Treatment
The role of "dermocosmetics" in acne management is increasingly important, as many patients and even physicians now resort to them as first-line management in mild-to-moderate acne.
The aim of the study is to demonstrate the efficacy of the tested product on the appearance of acne lesions in 30 adult women suffering from acne in the mandible following an active anti-acne therapy (systemic or topical). This study includes 2 months of cosmetic treatment with EFFACLAR Ultra Concentrated Serum and one month of followup without any treatment but a moisturizer with a daily UV protection.
The investigational product has been formulated with an ultra-concentrated tri-acids complex for a synergetic action on skin and reinforced with soothing niacinamide for optimal tolerance.
This product is expected:
The study is performed in the Centre de Pharmacologie Clinique Appliqué à la Dermatologie (CPCAD), authorized by the French Regional Agency of Health (ARS) to perform biomedical research (Site agreement n°: 2016-04).
This clinical trial protocol and all amendments will be reviewed and approved by an appropriate Independent Ethics Committee (IEC) (Comité de Protection des Personnes (CPP)) located in France. The clinical trial cannot start before CPP approval.
The clinical trial is conducted under the sponsorship of Sponsor in compliance with the applicable international and local regulatory requirements as well as applicable International Council on Harmonisation (ICH) guidelines and in accordance with the Standard Operating Procedures (SOPs) for clinical trial conduct and monitoring from the assigned monitor.
All statistical tests will be two-sided and at the 5% level of significance. Normality tests will be at the 1% level of significance (Shapiro-Wilk).
Regarding the analysis of efficacy endpoints, quantitative parameters are analyzed using a linear mixed model for repeated measurements with Baseline and Time as fixed effects and Subject as random effect. Each time-point is compared to Baseline using a Dunes adjustment for multiplicity correction. For each fitted model, residual plots will be used to check the model assumptions. If there is an obvious deviation to these assumptions, the analysis is done on the rank-transformed data. Ordinal parameters (GEA) are analyzed using a cumulative link mixed model for repeated measurements with Baseline and Time as fixed effects and Subject as random effect. Each time-point will be compared to Baseline using a Dunnett adjustment for multiplicity correction.
The analysis of cosmeticity/acceptability questionnaire is descriptive only and for the analysis of safety endpoints, no statistical analysis is performed on safety. The data are presented descriptively.
As for the sample size determination, a total of 30 subjects completing the whole study allows to answer to the study objectives.
Clinical Research Associates (CRAs) and other applicable personnel are trained prior to study initiation to familiarize CRAs with the disease, the Standard Operating Procedures (SOP), the protocol and other study specific items.
Regarding the data management, the study data will be collected on an electronic data capture (EDC) set up by the Contract Research Organization (CRO). Computerized edit checks and review processes will be performed on an ongoing basis until all data clarifications are resolved. The data will be exported from a special database to be stored in appropriate format. After all data clarifications are resolved, coding is approved, and subject's evaluability is determined, the database will be locked.
750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.
This study's enrollment of 30 is below the median of 69 across 647 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Cosmetique Active International is the lead sponsor of 55 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Participants are asked to apply Effaclar serum once daily in the evening on the whole face avoiding contact with eyes for 2 months.
Other: Effaclar serum
Effaclar serum has been formulated with an ultra-concentrated tri-acids complex for a synergetic action on skin and reinforced with soothing niacinamide for optimal tolerance. It acts in particular on imperfections and persistent marks due to acne.
change in GEA (Global Evaluation Acne) score
evaluation of the acne grade by the investigator on a 6-point scale (from 0 Clear. No lesions to 5 Very severe)
Time frame: from baseline to Day84
change in Adult Female Acne Scoring Tool (AFAST) score
evaluation of the acne grade by the investigator on a 4-point scale
Time frame: from baseline to Day84
change in acne count
lesion count by the investigator: inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (opened/closed comedones) on full face
Time frame: from baseline to Day84
change in the seborrhea evaluation
assessment performed by the investigator by visual inspection (gloss and shine aspect), and recorded using a 0-3 grading scale
Time frame: from baseline to Day84
change in subject's and Investigator's global assessment of efficacy
opinion given on the global efficacy of the study treatment at each visit (except Day0), using a 7-point scale
Time frame: from Day7 to Day84
change in the quantity of sebum
evaluation, with a Sebumeter, of the quantity of sebum excreted to the skin surface. Measurements will be done about 12 h after the last application of any product and 3 h minimum after the last washing of the skin at controlled room temperature (21-25 °C).
Time frame: from baseline to Day84
change in the quality of life
Cardiff Acne Disability Index (CADI) questionnaire with 5 questions
Time frame: Day0, Day14, Day28, Day56, Day84
change in the global tolerance
evaluation of the tolerance both by the investigator and the patient on a 5-point scale (from 0 None to 4 Very severe)
Time frame: from Day7 to Day84
change in the sensitivity assessment by the investigator
assessment of the following signs: erythema, dryness, desquamation by the investigator on a 0-3 score
Time frame: from Day48 hours (phone call) to Day84
change in the sensitivity assessment by the participant
assessment of the following symptoms: itching, tingling, burning sensation by the patient on a 0-3 score
Time frame: from Day48 hours (phone call) to Day84
Ran from Jan 2021 to primary completion in Jul 2021, 5 months.
Of 55 industry-sponsored interventional studies with no phase under Acne Vulgaris, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 64. This study's 5 months is below that.
Counting every sponsor, half of 116 studies reached it within 9 months; a quarter within 4 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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