An assessment of the safety and efficacy of the Acne Scar Treatment Pen to treat facial acne scars
- Conditions
- Ice-pick acne scarsSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN18051758
- Lead Sponsor
- Medical Brands B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 66
1. Healthy subject
2. Male or female
3. Written informed consent must be obtained from the subject
4. Age between 18 and 60 years
5. Phototype: Fitzpatrick skin types I, II, III, IV
6. Subjects with at least five icepick acne scars per hemiface, and with no more than 30% difference between the two sides of the face, as determined by clinical examination and with comparable pathology on each hemiface as judged by the Investigator
7. Subject having stopped any topical anti-acne treatment since at least 6 months before inclusion
8. Willing to refrain from receiving cosmetic face treatments for the duration of the study
9. Willing to use sunscreen for the duration of the study
10. Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end
1. Subject considered by the Investigator likely to be non-compliant with the protocol
2. Patient enrolled in another clinical trial during the test period
3. Woman being pregnant, nursing or planning a pregnancy during the course of this study
4. Subject having a known allergy to one of the constituents of the tested products
5. Patient suffering from serious or progressive diseases (to investigator's discretion), including but not limited to diabetes, peripheral circulatory disease, HIV, immunosuppressive pathology
6. Subject with cutaneous pathology on studied zone, including but not limited to acne, rosacea, angioma, dermatitis, herpes labialis
7. People who were treated with tretinoin within 6 months prior to treatment in this study
8. History of skin tightening or injectable filler of any type within the last year
9. History of facial laser treatment, including ablative and non-ablative resurfacing laser treatments and rejuvenation laser treatments in the last 6 months
10. History of cosmetic treatments with neurotoxins within the last 3 months
11. History of chemical peel or dermabrasion of face and neck within the last 4 weeks
12. History of keloid formation
13. History of hyperpigmentation
14. Fitzpatrick skin types V and VI
15. Prior poor reaction to a chemical peel
16. Subject who was abroad in a country with a higher incidence rate of Covid-19 than Poland, within 14 days before the beginning of the study.
17. Subject presenting following symptoms: cough, shortness of breath, elevated body temperature – equal and above 37.5°C
18. Subject who have had contact with any person infected with COVID-19 within 10 days before the beginning of the study
19. Subject who are currently home quarantined, as recommended by the Sanitary Inspection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acne scarring measured using the Clinician Global Impression (CGI) scale of improvement at baseline and 18 weeks
- Secondary Outcome Measures
Name Time Method