Effectiveness and Tolerance of Effaclar Serum in Women With Mandibular Acne

NCT05457621 | Completed

• 1 other identifier: LRP19011-EFFACLAR SERUM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• to leave the skin clean and smooth,
• to help unblock pores,
• to exfoliate dead skin cells and help the skin to appear smoother, softer and pore-less,
• to be non-comedogenic.

Conditions

Acne Vulgaris

Keywords

tri-acid complex serum; mandibular acne; microcomedones; maintenance regimen

Outcome Measures

Primary Outcomes (4)

• 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)

  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

  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

  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

  from baseline to Day84

Secondary Outcomes (6)

• change in subject's and Investigator's global assessment of efficacy

  from Day7 to Day84

• change in the quantity of sebum

  from baseline to Day84

• change in the quality of life

  Day0, Day14, Day28, Day56, Day84

• change in the global tolerance

  from Day7 to Day84

• change in the sensitivity assessment by the investigator

  from Day48 hours (phone call) to Day84

Study Arms (1)

Effaclar serum

EXPERIMENTAL

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

Interventions

Effaclar serum OTHER

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.

Effaclar serum

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Demonstrate the efficacy of Effaclar Ultra Concentrated Serum 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).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female subjects aged 20 years or above
• phototype II to IV
• mandibular acne (with or without diffuse acne)
• at baseline (Day0) a AFAST (Adult Female Acne Scoring Tool) score of 1 or 2 in the mandibular area and not over
• non-inflammatory lesions and 5 inflammatory lesions minimum (screening and baseline)
• microcomedones on the mandibular area (visible with Vivacube measurement),

You may not qualify if:

• men
• female subject pregnant or lactating or who intends to conceive a child during the clinical trial or within one month after the last clinical trial visit
• facial acne without mandibular acne
• still undergoing medical treatment for acne at baseline (D0)
• intensively exposed to UV within the month preceding the baseline visit
• history of any severe disease or current condition (based on subject's interview and/or results of screening physical examination) which, in the opinion of the Investigator would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results (e.g. cancer, immune disorders)

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

Nice, France

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Officials

• Catherine Queille-Roussel

  Centre de Pharmacologie Clinique Applique a la Dermatologie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants attend 7 visits (screening visit, inclusion visit, 4 intermediate visits, final visit) and make a visit by phone call at Day48 hours. They apply the investigational product once daily (evening) for 2 months on the whole face and the accompanying product twice daily for 3 months on the whole face.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: January 21, 2021
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

FR (1)