Evaluation of Effaclar Duo+M on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk

ConditionAcne
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCosmetique Active International

About this trial

This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

phototype I to VI

mild to moderate acne on the face and trunk

Disqualifiers

cutaneous pathology on the studied zone other than acne

topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products

Trial design

Design model

Single group

Treatments tested in this trial

  • acneic participants group

    Other intervention

    Application of Effaclar Duo+M to the face and trunk twice daily (morning and evening) after washing with the cleansing gel.

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: acneic participants groupOther 1 intervention

Trial outcomes

Primary outcomes

1

efficacy on total acne lesion count on face and trunk

The counting is performed by region (back, chest, face, total) and type of lesion (post-inflammatory hyperpigmentation, post-inflammatory erythema, scars, pustules, nodules, papules, closed comedones, open comedones.

Time frame
from baseline to Day168

Secondary outcomes

1

Evaluation of the degree of severity of acne on the face

Evaluation performed thanks to the Global Evaluation Acne (GEA) scale on a 6-point score: from 0 (Clean. No lesions) to 5 (Very severe).

Time frame
from baseline to Day168
2

Evaluation of the degree of severity of acne on the trunk

Evaluation performed thanks to the Investigator Global Assessment (IGA) scale on a 6-point score: from 0 (Absent) to 5 (Very serious).

Time frame
from baseline to Day168

Other outcomes

Sponsors and contacts

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