Cutaneous Acceptability, Comedogenic Potential and Efficacy of Two Cosmetic Products Used in Synergy

NCT05490537 | Completed

• 1 other identifier: LRP19013-EFFACLAR GEL AND DUO+
• Study Type: observational
• Target: 46
• Locations: 2 countries
• Sites: 2

Brief Summary

The open, intra-individual study aims to assess the cutaneous acceptability, comedogenic potential and efficacy of a cleansing gel and a cream used in synergy to relieve patients presenting with acne grade 2 and 3. Each subject is her/his own control.

Conditions

Acne

Keywords

acne; comedogenic potential; GEA

Outcome Measures

Primary Outcomes (4)

• change in cutaneous acceptability by the dermatologist with a 5-point scale

  assessment of the acceptability of the parameters erythema, edema, dryness, desquamation, roughness on a 5-point scale (none, very mild, mild, moderate, severe)

  from baseline to Day56

• change in cutaneous acceptability by the participant with a 5-point scale

  assessment of the acceptability of the parameters tightness, stinging, itching, warm/burning sensation on a 5-point scale (none, very mild, mild, moderate, severe)

  from baseline to Day56

• change in comedogenic potential

  The variations (Day28-Day0, Day56-Day0) in the number of lesions are calculated for each kind of lesions. Descriptive statistics are done in order to determine the variation significance. * a non-comedogenic product does not induce any significant increase in the number of retentional lesions. * a non-acnegenic product does not induce any significant increase in the number of inflammatory lesions.

  from baseline to Day56

• change in Global Evaluation Acne (GEA) score

  The dermatologist realizes clinical score of the product's anti-acne efficacy using the Investigator Global Acne Severity Score with a 6-point scale: from 0 Clear. No lesions. to 5. Very severe

  from baseline to Day56

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

participants with acne grade 2 and 3 meeting the inclusion and exclusion criteria and agreeing to the study contraints

You may qualify if:

• phototype I to VI according to the following distribution:
• female subjects of \<18 years old and phototype I or II, 7 male subjects of \<18 years old and phototype I or II, 7 female subjects of \>18 years old and phototype I or II, 7 male subjects of \>18 years old and phototype I or II,
• female subjects of \<18 years old and phototype III or IV, 7 male subjects of \<18 years old and phototype III or IV, 7 female subjects of \>18 years old and phototype III or IV, 7 male subjects of \>18 years old and phototype III or IV,
• female subjects of \<18 years old and phototype V or VI, 7 male subjects of \<18 years old and phototype V or VI, 7 female subjects of \>18 years old and phototype V or VI, 7 male subjects of \>18 years old and phototype V or VI
• Caucasian (in Dermscan in Poland) and Negroid (in Insight Research in Mauritius)

You may not qualify if:

• cutaneous pathology on the studied zone other than acne (eczema, ...)
• topical acne treatment since less than one month
• participant manipulating her/ his acne lesions
• excessive exposure to sunlight or UV-rays within the previous month
• use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products (according to the investigator's appreciation)

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (2)

Insight Research

Quatre Bornes, Mauritius

Location

Dermscan Poland Sp. z o. o.

Gdansk, Poland

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Officials

• Katarzyna Bednarczyk

  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 5, 2022
• Study Start: January 13, 2021
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

PL (1); MA (1)