Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment

This is an open controlled clinical trial. The product will be applied for a period of 4 weeks and 3 visits will be performed: a baseline visit (T0), an intermediate visit after 2 weeks (T2) and a final visit after 4 week-treatment (T4).

The subjects will be enrolled and divided in 2 groups according to their acne grade (20 subjects with mild/moderate grade and 20 subjects with moderately severe/severe), a concomitant therapy is allowed only for volunteers with acne moderately severe/severe.

Each volunteer, fulfilling the inclusion criteria, will perform a cosmetic treatment with the study product on all the face, for 4 weeks.

A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). Group 2 will continue also the standardised treatment with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA until the end of the study.

Inclusion criteria

• both genders;
• age > 16 years old;
• acne of mild/moderate grade, not in therapy (GROUP 1);
• acne of moderately severe/severe grade, in therapy with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA (GROUP 2);
• accepting to follow the instructions received by the investigator;
• available to return to the study centre at the protocol visits;
• accepting to not change the normal life habits regarding: food, physical activity, face cleansing;
• accepting not to receive any other drug/cosmetic treatment able to interfere with the study results;
• accepting to sign the informed consent form (under 18 years the signature of both parents is required).

Exclusion criteria

• Pregnancy (only for female subjects) - for subjects belonging to Group 2, a control pregnancy test could be required at T2 and T4 in case of assumption of an anti-acne drug with potential teratogenic effects; these subjects must confirm to use adequate contraceptive precautions in order to avoid pregnancies;
• lactation (only for female subjects);
• subjects whose insufficient adhesion to the study protocol is expected;
• subjects who changed the anti-acne therapy during the 2 months prior to the study inclusion;
• concomitant participation in other studies or in the last 3 months.