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

NCT ID: NCT04806594

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-25
• Study Completion Date: 2021-07-01

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.

Conditions

Acne; Scars

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Papix acne scar

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

Group Type: EXPERIMENTAL

Papix acne scar

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Relife S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurora Parodi

Role: PRINCIPAL_INVESTIGATOR

Ospedale Policlinico San Martino

Locations

Ospedale San Martino

Genova, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ReGl/19/PAS-Acn/001

Identifier Type: -

Identifier Source: org_study_id