Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar. (NCT04806594) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.
Italy40 participantsStarted 2020-09-25
Plain-language summary
The scope of this open label clinical trial is to evaluate and confirm the performance of Papix acne scar in the prevention and improvement of acne scars in subject suffering for mild to moderate acne. The product will be applied for 8 consecutive weeks and 3 clinical follow up visits will be performed.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
ā. Subject's or parents or guardian (depending on the age of the subject) written informed consent obtained prior to any study-related procedures;
ā. Male or female subjects aged ā„ 12 years of any race;
ā. Subjects with any Fitzpatrick skin phototype;
ā. Subjects with clinical diagnosis of mild to moderate acne vulgaris (IGA score 2 or 3) on the face;
ā. Presence of acne scars (all types included), of grade mild or moderate according to SGA;
ā. Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement.
Exclusion criteria
ā. Pregnant women
ā. Severe acne at inclusion or any acne requiring systemic treatment;
ā. Presence of facial warts or fungal infections;
ā. Active dermatitis on the face, rosacea, active herpes simplex;
ā. Keloids presence in the area to be treated or keloids development during the treatment period;
ā. History of radiation or skin tumors in the/close to the area to be treated in the past 5 years;
What they're measuring
1
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks