Ice-pick acne scars Skin and Connective Tissue Diseases
Conditions
Interventions
A variation of trichloroacetic (TCA) chemical peeling, called Chemical Reconstruction of Skin Scars (CROSS) method, which involves local serial application of relatively high concentration TCA (50-100
Sponsors
Medical Brands B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acne scarring measured using the Clinician Global Impression (CGI) scale of improvement at baseline and 18 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Impact of icepick acne scars on the quality of life at baseline and 18 weeks measured using a novel questionnaire 2. Visual changes in icepick acne scars after each treatment cycle (Baseline, D21, D42, D63, D84, D105, 135) measured by the number and type (superficial, shallow or deep) of ice pick acne scars by clinician evaluation 3. Scar color changes (hypopigmentation, hyperpigmentation, or no changes) and their duration measured by clinician evaluation at baseline, Day 21, Day 42, Day 63, Day 84, Day 105, Day 135 (Equivalent to clinic visits 1, 3, 4, 5, 6, 7 and 8). 4. Disappearance of color changes before the consecutive treatment and also by the end of the follow-up period (D135), assessed on a yes or no criteria. 5. Number of lesions with scarring, assessed by counting observations by clinician evaluation at baseline, Day 21, Day 42, Day 63, Day 84, Day 105, Day 135 (Equivalent to clinic visits 1, 3, 4, 5, 6, 7 and 8). 6. Patient Global Impression (PGI) of improvement of acne scars between baseline and final treatment assessed at baseline, D21, D42, D63, D84 and D105 Usability Endpoints: 7. The patient’s evaluation of pain/tolerance during the treatment assessed as their subjective evaluation of pain on a Likert scale. The patient’s subjective evaluation of pain acceptability during treatment (Likert scale) will also be assessed (baseline, D21, D42, D63, D84 and D105) 8. Patient satisfaction with the overall results of the treatment will be assessed on a Likert scale (assessed at baseline, D21, D42, D63, D84 and D105) 9. Patient satisfaction with the number of treatments required, assessed on a Likert scale (assessed at baseline, D21, D42, D63, D84 and D105) 10. Patients’ opinion on whether the product meets their expectations and whether they would recommend it, both assessed on a Likert scale (assessed at baseline, D21, D42, D63, D84 and D105) | — |
Countries
Poland
Outcome results
None listed