Striae Distensae
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTFractional radiofrequency and topical Tretinoin
Treatment of striae with fractional radiofrequency and topical tretinoin in combination
Treatment of striae with topical tretinoin alone
Treatment of striae with fractional radiofrequency alone
Sponsors
Merete Haedersdal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Primary outcome assessment is blinded
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in appearance of striae with GAIS | Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up | Standardized clinical photos from baseline and follow-up comparing treatments and assessed by blinded evaluator on the Global Aesthetic Improvement Scale (GAIS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of striae with POSAS | Baseline - 20 weeks follow-up (12 weeks after last treatment) | Standardized on-site assessment comparing treatments assessed by the subject and a blinded evaluator on the Patient-Observer Scar Assessment Scale (POSAS) |
| Evaluation of striae with imaging | Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up | Assessment of tissue interaction with imaging techniques |
| Subject satisfaction | Baseline - 20 weeks follow-up (12 weeks after last treatment) | Likert scale for subject satisfaction |
| Safety: LSR and AE/AR | Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up | Collection and registration of local skin reactions and AE/AR |
Countries
Denmark
Outcome results
None listed