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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806594
• Other study ID #: ReGl/19/PAS-Acn/001
• Status: Completed
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: January 2022
• Source: Relife S.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris
• Scars

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale San Martino	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Relife S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse event collection	To evaluate the local and general tolerability of PAPIX ACNE SCAR.	two weeks, 4 weeks and 8 weeks of treatment
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	treatment compliance	To evaluate the subject's adherence to treatment by the product accountability.	8 weeks
Secondary	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
Secondary	Treatment acceptability	To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.	8 weeks of treatment