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NCT Number: NCT06716398

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

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.

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Key information

Conditions

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

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNIFESP

São Paulo, 04024-002, Brazil

Location status: Recruiting

Location contact

Edileia BAGATIN, MD,PhD

CONTACT

[email protected]

+55 11 5579-2581

Edileia BAGATIN, MD,PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Assessment of number of total acne lesions on the face

    Time frame: Assessment after 24 weeks of use

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

Secondary outcomes

  1. Investigator's global assessment (IGA)

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

    Assessed by the investigator on the face on a 5-point scale ranged from 0 (clear) to 4 (severe)

  2. Acne lesions counting

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

    Number of all type of acne lesions by counting according to subject's photographs analysis using acne Artificial Intelligence

  3. Acne QoL questionnaire

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

    Assessed by the subject via a specific questionnaire of 19 questions

  4. Subject's Global change Assessment (SGA)

    Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use

    Assessed by the subject via a 7-point scale: SGA of acne severity

  5. Post-Inflammatory Hyperpigmentation (PIH) lesions counting

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

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

  6. Post-Inflammatory Erythema (PIE) lesions counting

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

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

  7. Subject's Global change Assessment (SGA) of post inflammatory lesions

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

    Assessed by the subject via a 7-point scale: SGA of post inflammatory lesions (PIH and PIE)

  8. Acne worsening/ relapse

    Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use

    Number and percentage of acne worsening/ relapse, defined by the investigator by the necessity to change the topical medical treatment and/ or to introduce an oral medical treatment for facial acne

  9. Time to relapse

    Time frame: Assessment after 4 weeks and 12 weeks of use, without reference medical treatment

    The time to first acne relapse will be calculated from the date of Visit 3 (start of maintenance phase) to the date of failure (acne relapse).

  10. Global tolerance assessed by the investigator on a 5-point scale

    Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use

  11. Compliance of the subjects to the product RV4133C

    Time frame: Through study completion, 6 months

    The subject will report his/her compliance in a subject's diary

  12. Cosmetic satisfaction as regards to the use of the test product RV4133C by Cosmetic acceptability questionnaire assessed by the patient

    Time frame: Assessed after 4 weeks of use

    A questionnaire with a scale from 0 to 10 responding to statements about the effect of the product (0=not at all agree, 10=completely agree).

Study contacts

Contact information is provided by the study sponsor or research team.

Adeline Bacquey

CONTACT

[email protected]

+33562877753

Christophe Chamard

CONTACT

[email protected]

+33562488566

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

A Randomized Investigator-blinded Comparative Study to Assess the Efficacy of the Cosmetic Care Product RV4133C - Formula JT2559 in Subjects With Facial Acne, During a 3-month-associated-treatment Phase Followed by a 3-month-maintenance Phase

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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