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

Study Overview
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Brief Summary
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Primary end point of the study is the clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade and 20 subjects with a moderately severe/severe grade, according to Cunliffe' classification. Secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers and the local tolerability assessed by the investigator and the subjects.

Detailed Description
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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.

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

Conditions
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Acne

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| not in therapy (GROUP 1)<br>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). | |
| in therapy (GROUP 2)<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne | Visual evaluations (comedones, dryness, desquamation, papules, pustoles, microcystis) Tissue dielectric constant (superficial and deep hydration), sebumetry and optical colorimetry (skin colour), follicular biopsy, sebutape image analysis | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjects' self assessment |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne,comedones, oily skin