Management of Side-Effects of Anti-Acne Treatment by a Cosmetic Routine

NCT05486910 | Completed

• 1 other identifier: LRP20026-EFFACLAR SENSIBIOME
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Retinoid-based topical acne treatment may induce local tolerance issues such as erythema, dryness, stinging and burning sensations that may reduce adherence and efficacy. The tested regimen (cream and cleanser) has been specifically developed to rebalance the skin microbiome and compensate side-effects of topical treatments (hydration, skin barrier repair) together with an action on skin imperfections and marks. This open-label study was conducted in subjects aged 12 years and over with sensitive skin (\>2 on a sensitivity composite score from 0-3) treated for at least one month with the fixed-dose gel combination and presenting with treatment-related skin intolerance.

Conditions

Acne

Keywords

acne; efficacy; tolerance; dermocosmetic; quality of life

Outcome Measures

Primary Outcomes (2)

• change in comedogenic potential

  counting of retentional and inflammatory elements on the whole face. Descriptive statistics are done in order to determine the variation significance.

  from baseline to Day28

• change in Global Evaluation Acne (GEA) score

  The dermatologist realizes clinical score on the face using the Investigator Global Acne Severity Score : from 0 Clear. No lesions to 5 Very severe.

  from baseline to Day28

Secondary Outcomes (7)

• change in sensitivity score by the dermatologist

  from baseline to Day28

• change in sensitivity score by the participant (composite score)

  from baseline to Day28

• change in global tolerance score by the dermatologist

  from baseline to Day28

• change in global tolerance score by the participant

  from baseline to Day28

• change in overall effectiveness score by the dermatologist

  from baseline to Day28

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

participants with a failed anti-acne routine meeting the inclusion and exclusion criteria and agreeing to the study constraints

You may qualify if:

• Caucasian;
• phototype I to IV
• subject under EPIDUO® with a failed cosmetic routine for more than 1 month.
• subject agreeing to change their routine (introduction of the EFFACLAR routine).
• subject under anti-acne treatment since 1 month, with an usual routine in failure
• subject who presents irritated skin due to EPIDUO® treatment

You may not qualify if:

• pregnant or nursing woman or woman planning a pregnancy during the study
• cutaneous pathology on the studied zone other than acne (eczema etc.)
• use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability of the study product (according to the investigator's appreciation, except the anti-acne treatment Epiduo and former cosmetic routine)
• oral treatment of retinoids during the six previous months of the study
• any change in hormonal treatment (including contraceptive) during the three previous months of the study or subject under Androcur® generic) treatments since less than six months
• professional facial care during the study or within the previous month
• subject manipulating her/ his acne lesions
• excessive exposure to sunlight or UV-rays within the previous month

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

Studio Dermatologia i Kosmetyka

Malbork, Poland

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Officials

• Anna Czermanska

  Eurofins

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: April 29, 2021
• Primary Completion: July 29, 2021
• Study Completion: July 29, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

PL (1)