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

NCT ID: NCT06716398

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-03

Study Completion Date

2025-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acne

Keywords

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acne face young adults teenagers treatment phase maintenance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test Group

Group Type EXPERIMENTAL

Test product

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Comparator product

Intervention Type 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.

Interventions

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Test product

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.

Intervention Type OTHER

Comparator product

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
* Subject for whom a prescription of 12 weeks of a reference topical medical treatment is required from the day of the inclusion visit, for mild to moderate face acne

Exclusion Criteria

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UNIFESP

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Adeline Bacquey

Role: CONTACT

Phone: +33562877753

Email: [email protected]

Christophe Chamard

Role: CONTACT

Phone: +33562488566

Email: [email protected]

Facility Contacts

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Edileia BAGATIN, MD,PhD

Role: primary

Other Identifiers

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RV4133C20230380

Identifier Type: -

Identifier Source: org_study_id