Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin: An Intra-individual Study With Blinded Outcome Assessment
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merete Haedersdal
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Improvement in appearance of striae with GAIS
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Primary outcome assessment is blinded
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject has provided written informed consent
- •Subject is 18 years of age or older
- •Fitzpatrick skin type I-III
- •Striae albae (grade II-IV) ≥1 year of age and ≥ 4 lesions with a length of ≥ 2 cm each
- •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
- •Severe concurrent conditions such as cardiac disorders or poorly regulated diabetes
- •History of skin disorders such as keloids, abnormal wound healing or very fragile skin
- •History of heat-stimulated disease such as herpes simplex in the treatment area
- •History of bleeding coagulopathies or use of anti-coagulants
- •Surgery in the treatment area past 6 months or before complete healing
- •Tattoo or permanent make-up in treatment area
- •Excessively tanned skin from sun, tanning bed or tanning creams last 2 weeks
- •Dermabrasion, resurfacing, soft tissue/fat injections or chemical peeling in treatment area the past 3 months
- •Abnormal skin (e.g. rash, infection, dermatitis) at the treatment area at the time of inclusion
- •Treatment with Isotretinoin within the past 6 months
Arms & Interventions
Combination therapy: Fractional radiofrequency and topical tretinoin
3 study treatments: at baseline, 1-month, 2-month with subsequent application of topical tretinoin. Home application of tretinoin between study visits
Intervention: Fractional radiofrequency and topical Tretinoin (Combination Product)
Fractional radiofrequency
3 study treatments: at baseline, 1-month, 2-month
Intervention: Fractional radiofrequency (Device)
Topical tretinoin
Application at study visits and home application between study visits
Intervention: Topical Tretinoin (Drug)
Outcomes
Primary Outcomes
Improvement in appearance of striae with GAIS
Time Frame: 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 Outcomes
- Evaluation of striae with POSAS(Baseline - 20 weeks follow-up (12 weeks after last treatment))
- Evaluation of striae with imaging(Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up)
- Safety: LSR and AE/AR(Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up)
- Subject satisfaction(Baseline - 20 weeks follow-up (12 weeks after last treatment))
Investigators
Merete Haedersdal
Consultant in Dermatology, Clinical Professor
Bispebjerg Hospital