Clinical trial NCT04806594: Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Scars
Keywords: cream
mild moderate acne
Papix
Papix acne scar
acne treatment
Lead sponsor: Relife S.r.l.
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, open label, uncontrolled, single arm, post-market clinical follow-up study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks
timeFrame: four weeks of treatment
Secondary outcomes:
measure: Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment
timeFrame: two weeks of treatment and 8 weeks of treatment, week 8 reported
measure: Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment
timeFrame: assested at two weeks, 4 weeks and 8 weeks, week 8 reported
measure: Acne Investigator Global Assessment (IGA) Scores
timeFrame: assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4)
measure: Change of Skin Roughness
timeFrame: assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4)
measure: Number of Partecipants With Skin Texture Improvement
timeFrame: assested at two weeks, 4 weeks and 8 weeks, week 8 reported
measure: Number of Partecipants Compliant to Treatment
timeFrame: 8 weeks
measure: Subject and Investigator Global Evaluation of Performance
timeFrame: 8 weeks of treatment ( visit 4)
measure: Treatment Acceptability
timeFrame: 8 weeks of treatment ( visit 4)
Other outcomes:
measure: Number of Partecipants With Adverse Events
timeFrame: two weeks, 4 weeks and 8 weeks of treatment
Locations:
city: Genova
country: Italy
facility: Ospedale San Martino
Study officials:
affiliation: Ospedale Policlinico San Martino
name: Aurora Parodi
role: PRINCIPAL_INVESTIGATOR
References: