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

Acne Clinical Trial

Official title:

Evaluation of the Management of Side-Effects of Anti-Acne Treatment by a Cosmetic Routine Following Failure of the Usual Cosmetic Routine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05486910
• Other study ID #: LRP20026-EFFACLAR SENSIBIOME
• Status: Completed
• Start date: April 29, 2021
• Est. completion date: July 29, 2021

Study information

• Verified date: August 2022
• Source: Cosmetique Active International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The study on the evaluation of the management of side-effects of an anti-acne treatment by a cosmetic routine (cleanser and cream) following failure of the usual cosmetic routine has been conducted under dermatological control by Dermscan that is certified by the International Standards Organization (ISO) 9001-2015.

Each study report is subjected to a quality inspection by a proofreader member of Dermscan not involved in the audited study. The inspection of the study report allows to confirm that the results reflect exactly the study raw data and that the study fulfills any standard and regulatory requirements.

Regarding the statistical analysis, data obtained for each parameter, at each measurement time and on each zone are presented in raw value tables. The tables also show the descriptive statistics: means, medians, minima, maxima, standard errors of the means (SEM), confidence intervals of 95% (CI 95%) of these values as well as the variations and percentage variations. They also present the results of the statistical analysis.

Participants have the right to exit from the study at any time and for any motive in compliance with the Helsinki Declaration (1964) and its successive updates. The investigator can also interrupt the subject participation in the study prematurely in the case of a disease occurrence, a pregnancy or the occurrence of an adverse reaction.

The personnel in charge of the study collects data into individual case report forms in electronic or paper format and/or directly from measurement software. When information is collected in paper format, the double data entry is then done from these supports by the designed operator(s), without any interpretation, in specific EXCEL databases. The Project Manager or assistant checks the double data entry by comparing both databases. Then the coherence of the whole data set is checked as well as formulas used in the EXCEL tables (calculation formulas, selected data…). When all the controls are done, the database is locked.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 29, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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).

• subjects with moderate skin sensitivity: composite score >2 at the inclusion (burning sensation, tightness and itching) with 4 grades: absent, slight, medium and severe

• subject under anti-acne treatment since 1 month, with an usual routine in failure

• subject who presents irritated skin due to EPIDUO® treatment

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Locations

Country	Name	City	State
Poland	Studio Dermatologia i Kosmetyka	Malbork

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	change in sensitivity score by the dermatologist	evaluation of the parameters erythema, dryness, desquamation on a 0-3 scale	from baseline to Day28
Secondary	change in sensitivity score by the participant (composite score)	evaluation of the parameters itching, tightness, burning sensation on a 0-3 scale	from baseline to Day28
Secondary	change in global tolerance score by the dermatologist	evaluation of the tolerance on a 0-3 scale	from baseline to Day28
Secondary	change in global tolerance score by the participant	evaluation of the tolerance on a 0-3 scale	from baseline to Day28
Secondary	change in overall effectiveness score by the dermatologist	evaluation of the effectiveness on a 0-3 scale	from baseline to Day28
Secondary	change in overall effectiveness score by the participant	evaluation of the effectiveness on a 0-3 scale	from baseline to Day28
Secondary	change in quality of life	Cardiff Acne Disability Index (CADI) questionnaire with 5 questions	from baseline to Day28