Health TrialsbyHealthPanel

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

ConditionAcne
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-24
SponsorPierre Fabre Dermo Cosmetique

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Test product

    Other intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Test GroupExperimental treatment 1 intervention
Group B: Comparative groupPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
Assessment after 24 weeks of use

Secondary outcomes

1

Investigator's global assessment (IGA)

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

Time frame
Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
2

Acne lesions counting

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

Time frame
Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
3

Acne QoL questionnaire

Assessed by the subject via a specific questionnaire of 19 questions

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

Subject's Global change Assessment (SGA)

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pierre Fabre Dermo Cosmetique

Lead sponsor

Source ClinicalTrials.gov
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