Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin: An Intra-individual Study With Blinded Outcome Assessment

SDRFTT

The study aims to explore the potential of combination therapy with fractional radiofrequency and topical tretinoin for treatment and overall improvement of striae albae. We also aim to assess subject satisfaction, local skin responses and adverse effects/reactions in relation to the treatments, alone and in combination.

2022-11-22

2023-07-05

2023-07-05

Completed

Early phase I

20

Inclusion Criteria: 1. Subject has provided written informed consent 2. Subject is 18 years of age or older 3. Fitzpatrick skin type I-III 4. Striae albae (grade II-IV) ≥1 year of age and ≥ 4 lesions with a length of ≥ 2 cm each 5. Women of childbearing potential are not pregnant (confirmed by a negative u-HCG prior to study treatments) and use a safe contraceptive method prior to treatments. Exclusion Criteria: 1. Severe concurrent conditions such as cardiac disorders or poorly regulated diabetes 2. History of skin disorders such as keloids, abnormal wound healing or very fragile skin 3. History of heat-stimulated disease such as herpes simplex in the treatment area 4. History of bleeding coagulopathies or use of anti-coagulants 5. Surgery in the treatment area past 6 months or before complete healing 6. Tattoo or permanent make-up in treatment area 7. Excessively tanned skin from sun, tanning bed or tanning creams last 2 weeks 8. Dermabrasion, resurfacing, soft tissue/fat injections or chemical peeling in treatment area the past 3 months 9. Abnormal skin (e.g. rash, infection, dermatitis) at the treatment area at the time of inclusion 10. Treatment with Isotretinoin within the past 6 months 11. Use of non-steroidal anti-inflammatory drugs 1 week prior to treatment 12. Known allergies to tretinoin or lidocaine/prilocaine 13. History of cancer including pre-malignant moles 14. Impaired immune system due to immunosuppressive disease or medication 15. Electronic device implant 16. Any implantable metal piece or permanent chemical substance in treatment area 17. If female; lactating, pregnant or planning on becoming pregnant during the study 18. Non-eligibility at the discretion of the investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single-center, prospective, randomized and intra-individual clinical trial comparing untreated striae (controls) to striae treated with topical tretinoin and radiofrequency, respectively, and to combination therapy.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Primary outcome assessment is blinded', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2023-08-14