Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

Study Overview
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Brief Summary
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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.

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

Conditions
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Striae Distensae

Intervention / Treatment
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* Combination Product: Fractional radiofrequency and topical Tretinoin
* Drug: Topical Tretinoin
* Device: Fractional radiofrequency


Participation Criteria
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Eligibility Criteria
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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 Use of non-steroidal anti-inflammatory drugs 1 week prior to treatment Known allergies to tretinoin or lidocaine/prilocaine History of cancer including pre-malignant moles Impaired immune system due to immunosuppressive disease or medication Electronic device implant Any implantable metal piece or permanent chemical substance in treatment area If female; lactating, pregnant or planning on becoming pregnant during the study Non-eligibility at the discretion of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination therapy: Fractional radiofrequency and topical tretinoin<br>3 study treatments: at baseline, 1-month, 2-month with subsequent application of topical tretinoin. Home application of tretinoin between study visits | Combination Product: Fractional radiofrequency and topical Tretinoin<br>* Treatment of striae with fractional radiofrequency and topical tretinoin in combination<br>* Other names: VenusViva MD, Retirides;|
| Active Comparator: Fractional radiofrequency<br>3 study treatments: at baseline, 1-month, 2-month | Device: Fractional radiofrequency<br>* Treatment of striae with fractional radiofrequency alone<br>* Other names: VenusViva MD;|
| Active Comparator: Topical tretinoin<br>Application at study visits and home application between study visits | Drug: Topical Tretinoin<br>* Treatment of striae with topical tretinoin alone<br>* Other names: Retirides;|
| No Intervention: Untreated control<br>No study treatments | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in appearance of striae with GAIS | Standardized clinical photos from baseline and follow-up comparing treatments and assessed by blinded evaluator on the Global Aesthetic Improvement Scale (GAIS) | Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of striae with POSAS | Standardized on-site assessment comparing treatments assessed by the subject and a blinded evaluator on the Patient-Observer Scar Assessment Scale (POSAS) | Baseline - 20 weeks follow-up (12 weeks after last treatment) | 
| Evaluation of striae with imaging | Assessment of tissue interaction with imaging techniques | Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up | 
| Subject satisfaction | Likert scale for subject satisfaction | Baseline - 20 weeks follow-up (12 weeks after last treatment) | 
| Safety: LSR and AE/AR | Collection and registration of local skin reactions and AE/AR | Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up |