Evaluation of Efficacy and Tolerance of Crystal Peel in the Treatment of Adults Presenting Facial… (NCT05821296) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Efficacy and Tolerance of Crystal Peel in the Treatment of Adults Presenting Facial Mild Acne
Poland42 participantsStarted 2023-01-23
Plain-language summary
The goal of this interventional, confirmatory and post market study is to evaluate the efficacy and clinical performance of Crystal Peel in adults suffering mild facial acne vulgaris. The principal and secondary aims are:
* Principal aim: to evaluate the efficacy and clinical performance of Crystal Peel, a salicylic-based peel, for the treatment of acne by lesions counting (front, 2 cheeks, the chin above the jaw line (excluding the nose)) using both visual observation and palpation.
* Secondary aims: pores and texture analysis, visual effect (Standardized anonymized photographs, investigator global assessment, patient global assessment, local and overall tolerance of the Crystal Peel, subject's self-evaluation and potential adverse events collection.
The primary endpoint of the study will be an objective counting of the acne lesions performed on every visit.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Healthy subjects
✓. Gender: female and/or male.
✓. Age: 18 - 45
✓. Phototype I to IV according Fitzpatrick scale.
✓. Healthy subject with normal physical examination results and a medical history compatible with the requirements of the study.
✓. A healthy male or female subject with a medical diagnosis of mild to moderate facial acne vulgaris defined by at least 6 (six) inflammatory lesions, 12 (twelve) non-inflammatory lesions and no more than 2 (two) nodules (the nose is excluded for lesion count purposes).
✓. Subject declares to avoid exposure to UV radiation (tanning booths, phototherapy and sun) on the face for at least three months prior to the selection visit and agrees to avoid it throughout the study.
✓. Subject agrees not to apply any cosmetic, medical or aesthetic treatments outside the study protocol on the face for the duration of the study.
Exclusion criteria
What they're measuring
1
Comparison of the Change From Baseline of Count Lesions on Each Visit to Evaluate the Efficacy and Clinical Performance of Crystal Peel for the Treatment of Acne.
Timeframe: At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).
. Pregnant or nursing woman or planning a pregnancy during the study.
✕. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
✕. Subject in a social or sanitary establishment.
✕. Subject participating to another clinical research or being in an exclusion period for a previous study.
✕. Intensive exposure to sunlight or UV-rays within the previous 3 months and foreseen during the study.
✕. Subject with any skin or systemic disease (acute and/or chronic), in the previous year, likely to interfere with the measured parameters or to put the subject to an undue risk.
✕. Subject having history of allergy or hypersensitivity to one of the components of the tested device.
✕. Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk.