Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.

Study Overview
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Brief Summary
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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.

Detailed Description
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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, 2 times per day into the face. The dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product.

Official Title
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Open Label, Uncontrolled Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar in the Prevention and Improvement of Scars and Lesions Associated With Acne

Conditions
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Acne, Scars

Intervention / Treatment
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* Device: Papix acne scar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject's or parents or guardian (depending on the age of the subject) written informed consent obtained prior to any study-related procedures; Male or female subjects aged ≥ 12 years of any race; Subjects with any Fitzpatrick skin phototype; Subjects with clinical diagnosis of mild to moderate acne vulgaris (IGA score 2 or 3) on the face; Presence of acne scars (all types included), of grade mild or moderate according to SGA; 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: Pregnant women Severe acne at inclusion or any acne requiring systemic treatment; Presence of facial warts or fungal infections; Active dermatitis on the face, rosacea, active herpes simplex; Keloids presence in the area to be treated or keloids development during the treatment period; History of radiation or skin tumors in the/close to the area to be treated in the past 5 years; Laser ablative procedures within the last month; Chemical peels within the last 6 months; Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, hydroxy acids and other antinflammatory drugs within 2 weeks; Use of topical retinoids within 4 weeks; Use of systemic corticosteroids or antibiotics in the previous 30 days; Use of systemic spironolactone/drospirenone or immunomodulators in the previous 3 months; Use of oral retinoids or cyproterone acetate/chlormadinone acetate in the previous 6 months; Use of scrub, alpha hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start; Subjects with any other clinically significant or unstable concurrent disease or skin condition or general condition that, in the Investigator's opinion, might interfere with the study evaluations; Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients; Concomitant or previous participation in other interventional clinical study in the past 3 months; Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study. In case of sun exposure this shall be limited and a protection cream (SPF 50+) shall be applied.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Multicenter, open label, uncontrolled, single arm, post-market clinical follow-up study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Papix acne scar<br>Papix acne scar gel for 8 consecutive weeks, 2 times per day | Device: Papix acne scar<br>* PapiX acne scar, class IIa medical device, gel for acne scar. to be applied 2 times per day during the 8 weeks of study duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate and confirm the performance of PAPIX ACNE SCAR in the prevention and improvement of scars in subject suffering for mild to moderate acne, after 4 weeks of treatment | Indicate the proportion of subjects with improved acne scars and marks respect to baseline and, at the same time, without any new facial acne scars after 4 weeks of treatment with the change in the qualitative Scar Global Assessment (SGA) questionnaire. | four weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the performance of PAPIX ACNE SCAR in the prevention and improvement of scars after 2 and 8 weeks of treatment. | Indicate the proportion of subjects with improved acne scars and marks with respect to baseline and, at the same time, without any new facial acne scars after 2 and 8 weeks of treatment. The improvement of acne scars and marks will be assessed as the change in the qualitative Scar Global Assessment (SGA) questionnaire | two weeks of treatment and 8 weeks of treatment | 
| To evaluate the performance of PAPIX ACNE SCAR in the prevention of lesions after 2, 4 and 8 weeks of treatment | Indicate the prevention of acne lesions after 2, 4 and 8 weeks of treatment. | two weeks, 4 weeks and 8 weeks of treatment | 
| evaluate acne severity | To evaluate acne severity after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment. | two weeks, 4 weeks and 8 weeks of treatment | 
| skin roughness improvement | To evaluate the improvement of the skin roughness after 2, 4 and 8 weeks of treatment.through the Investigator Global Assessment | two weeks, 4 weeks and 8 weeks of treatment | 
| skin texture improvement | To evaluate the change in skin texture after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment | two weeks, 4 weeks and 8 weeks of treatment | 
| treatment compliance | To evaluate the subject's adherence to treatment by the product accountability. | 8 weeks | 
| Subject and Investigator Global Evaluation of Performance | To evaluate the subject's and Investigator's global evaluation of satisfaction with regards to the performance of PAPIX ACNE SCAR through a specific questionnaire. | 8 weeks of treatment | 
| Treatment acceptability | To evaluate the subject's overall acceptability of the treatment through a specific questionnaire. | 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cream, mild moderate acne, Papix, Papix acne scar, acne treatment