Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

Phase 2

Completed

• Conditions: Striae Distensae
• Interventions: Combination Product: Fractional radiofrequency and topical Tretinoin; Device: Fractional radiofrequency; Drug: Topical Tretinoin

• Registration Number: NCT05461755
• Lead Sponsor: Merete Haedersdal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-18
• Study Start: 2022-11-22
• Primary Completion: 2023-07-05
• Study Completion: 2023-07-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination therapy: Fractional radiofrequency and topical tretinoin	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
Fractional radiofrequency	Fractional radiofrequency	3 study treatments: at baseline, 1-month, 2-month
Topical tretinoin	Topical Tretinoin	Application at study visits and home application between study visits

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Subject satisfaction	Baseline - 20 weeks follow-up (12 weeks after last treatment)	Likert scale for subject satisfaction

Trial Locations

Locations (1)

Department of Dermatology, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark