A Comparative Study of Cosmetic Product in Subjects With Facial Acne During an Associated-treatment Phase Followed by a Maintenance Phase

NCT06716398 | Recruiting

• 1 other identifier: RV4133C20230380
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we are interested in the global benefit of the tested product as complementary care to a topical medical treatment during a 3 month-associated treatment phase followed by a 3 month-maintenance phase, compared to a light moisturizing cream, in teenagers and adults with acne. We also want to evaluate the tolerance of the tested product in association and in maintenance of the topical medical treatment.

Conditions

Acne

Keywords

acne; face; young adults; teenagers; treatment phase; maintenance

Outcome Measures

Primary Outcomes (1)

• Assessment of number of total acne lesions on the face

  Number of total acne lesions by counting according to the Lucky method performed by the investigator

  Assessment after 24 weeks of use

Secondary Outcomes (12)

• Investigator's global assessment (IGA)

  Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use

• Acne lesions counting

  Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use

• Acne QoL questionnaire

  Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use

• Subject's Global change Assessment (SGA)

  Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use

• Post-Inflammatory Hyperpigmentation (PIH) lesions counting

  Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use

Study Arms (2)

Test Group

EXPERIMENTAL

Other: Test product

Comparative group

PLACEBO COMPARATOR

Other: Comparator product

Interventions

Test product OTHER

Twice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face.

Test Group

Comparator product OTHER

Twice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face.

Comparative group

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or Female aged between 14 and 24 years (included)
• Subject with facial acne with score index severity IGA = 2 or 3, assessed on a scale ranged from 0 to 4.

You may not qualify if:

• Criteria related to the disease:
• Facial skin disease other than acne, skin abnormalities, or dermatological condition on the face liable to interfere with the study assessments
• Acne conglobata, Acne fulminans, nodulocystic acne or acneiform eruptions, according to investigator's assessment
• Other type of pigmentation disorder than acne-related PIH liable to interfere with the study assessments according to the investigator
• Criteria related to treatments and/or products:
• \- Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

UNIFESP

São Paulo, 04024-002, Brazil

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris; Facies

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Adeline Bacquey

CONTACT

+33562877753; adeline.bacquey@pierre-fabre.com

Christophe Chamard

CONTACT

+33562488566; christophe.chamard@pierre-fabre.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: July 3, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)