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

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

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.

Study Overview

• Status: Completed
• Conditions: Scars; Acne
• Intervention / Treatment: Device: Papix acne scar

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy, 16132
    • Ospedale San Martino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject's or parents or guardian (depending on the age of the subject) written informed consent obtained prior to any study-related procedures;
2. Male or female subjects aged ≥ 12 years of any race;
3. Subjects with any Fitzpatrick skin phototype;
4. Subjects with clinical diagnosis of mild to moderate acne vulgaris (IGA score 2 or 3) on the face;
5. Presence of acne scars (all types included), of grade mild or moderate according to SGA;
6. 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:

1. Pregnant women
2. Severe acne at inclusion or any acne requiring systemic treatment;
3. Presence of facial warts or fungal infections;
4. Active dermatitis on the face, rosacea, active herpes simplex;
5. Keloids presence in the area to be treated or keloids development during the treatment period;
6. History of radiation or skin tumors in the/close to the area to be treated in the past 5 years;
7. Laser ablative procedures within the last month;
8. Chemical peels within the last 6 months;
9. Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, hydroxy acids and other antinflammatory drugs within 2 weeks;
10. Use of topical retinoids within 4 weeks;
11. Use of systemic corticosteroids or antibiotics in the previous 30 days;
12. Use of systemic spironolactone/drospirenone or immunomodulators in the previous 3 months;
13. Use of oral retinoids or cyproterone acetate/chlormadinone acetate in the previous 6 months;
14. Use of scrub, alpha hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start;
15. 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;
16. Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients;
17. Concomitant or previous participation in other interventional clinical study in the past 3 months;
18. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Papix acne scar; Papix acne scar gel for 8 consecutive weeks, 2 times per day	Device: Papix acne scar; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks	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.	four weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 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, week 8 reported
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment	Proportion of subjects at week 2, 4 and 8 of treatment, without any new facial acne lesions with respect to baseline (Visit 1).	assested at two weeks, 4 weeks and 8 weeks, week 8 reported
Acne Investigator Global Assessment (IGA) Scores	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;	assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4)
Change of Skin Roughness	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)	assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4)
Number of Partecipants With Skin Texture Improvement	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).	assested at two weeks, 4 weeks and 8 weeks, week 8 reported
Number of Partecipants Compliant to Treatment	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 ( visit 4)
Treatment Acceptability	To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.	8 weeks of treatment ( visit 4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Partecipants With Adverse Events	To evaluate the local and general tolerability of PAPIX ACNE SCAR.	two weeks, 4 weeks and 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Relife S.r.l.
• Investigators: Principal Investigator: Aurora Parodi, Ospedale Policlinico San Martino, Genova

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: cream; mild moderate acne; Papix; Papix acne scar; acne treatment
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: ReGl/19/PAS-Acn/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No