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

NCT04806594 | Completed Results

• 1 other identifier: ReGl/19/PAS-Acn/001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne; Scars

Keywords

cream; mild moderate acne; Papix; Papix acne scar; acne treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment

  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

  assested at two weeks, 4 weeks and 8 weeks, week 8 reported

• Acne Investigator Global Assessment (IGA) Scores

  assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4)

• Change of Skin Roughness

  assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4)

• Number of Partecipants With Skin Texture Improvement

  assested at two weeks, 4 weeks and 8 weeks, week 8 reported

Other Outcomes (1)

• Number of Partecipants With Adverse Events

  two weeks, 4 weeks and 8 weeks of treatment

Study Arms (1)

Papix acne scar

EXPERIMENTAL

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

Device: Papix acne scar

Interventions

Papix acne scar 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

Papix acne scar

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women
• 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;

Sponsors & Collaborators

• Relife S.r.l.: lead

Study Sites (1)

Ospedale San Martino

Genova, 16132, Italy

Location

MeSH Terms

Conditions

Acne Vulgaris; Cicatrix

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Relife Srl

sdipalma@relifecompany.it

055 56809345

Study Officials

• Aurora Parodi

  Ospedale Policlinico San Martino

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, open label, uncontrolled, single arm, post-market clinical follow-up study.

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: March 19, 2021
• Study Start: September 25, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)