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

Not Applicable

Completed

Conditions: Acne
Scars

Interventions: Device: Papix acne scar

Registration Number: NCT04806594

Lead Sponsor: Relife S.r.l.

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Papix acne scar	Papix acne scar	Papix acne scar gel for 8 consecutive weeks, 2 times per day

Primary Outcome Measures

Name	Time	Method
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks	four weeks of treatment	The primary endpoint will be the proportion of subjects with acne scars and marks improved with respect to baseline and, at the same time, without any new facial acne scars after 4 weeks of treatment (treatment success). The improvement of acne scars and marks will be assessed as the change of at least one grade in the qualitative Scar Global Assessment (SGA) by Goodman and Baron between baseline and Week 4. The number of new acne scars will be assessed by count and comparison with baseline.

Secondary Outcome Measures

Name	Time	Method
Change of Skin Roughness	assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4)	To evaluate the improvement of the skin roughness after 2, 4 and 8 weeks of treatment.through the Investigator Global Assessment Acne Investigator Global Assessment (IGA)
Number of Partecipants With Skin Texture Improvement	assested at two weeks, 4 weeks and 8 weeks, week 8 reported	To evaluate the change in skin texture after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment. Acne Investigator Global Assessment (IGA).
Number of Partecipants Compliant to Treatment	8 weeks	To evaluate the subject's adherence to treatment by the product accountability.
Subject and Investigator Global Evaluation of Performance	8 weeks of treatment ( visit 4)	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.
Acne Investigator Global Assessment (IGA) Scores	assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4)	To evaluate acne severity after 2 weeks (visit 2), 4weeks (visit 3) and 8 weeks (visit 4) of treatment, through the Investigator Global Assessment. Acne Investigator Global Assessment (IGA). Five different grades were used to define the acne severity: 0 Clear, 1 Almost Clear, 2 Mild, 3 Moderate, 4 Severe;
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment	assested at two weeks, 4 weeks and 8 weeks, week 8 reported	Proportion of subjects at week 2, 4 and 8 of treatment, without any new facial acne lesions with respect to baseline (Visit 1).
Treatment Acceptability	8 weeks of treatment ( visit 4)	To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.