Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

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

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 Overview

• Status: Completed
• Conditions: Striae Distensae
• Intervention / Treatment: Combination product: Fractional radiofrequency and topical Tretinoin; Device: Fractional radiofrequency; Drug: Topical Tretinoin

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gabriela Grove, MD; Phone Number: +45 24 45 43 93; Email: ggro0013@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Department of Dermatology, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Combination product: Fractional radiofrequency and topical Tretinoin; Treatment of striae with fractional radiofrequency and topical tretinoin in combination; Other Names: VenusViva MD, Retirides
Active Comparator: Fractional radiofrequency; 3 study treatments: at baseline, 1-month, 2-month	Device: Fractional radiofrequency; Treatment of striae with fractional radiofrequency alone; Other Names: VenusViva MD
Active Comparator: Topical tretinoin; Application at study visits and home application between study visits	Drug: Topical Tretinoin; Treatment of striae with topical tretinoin alone; Other Names: Retirides
No Intervention: Untreated control; No study treatments

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merete Haedersdal
• Investigators: Principal Investigator: Merete Haedersdal, MD PhD DMSc, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): July 5, 2023
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Striae Distensae; Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Tretinoin
• Other Study ID Numbers: SDRFTT; 2021-003153-39 (EudraCT Number); H-21038853 (Other Identifier: The Regional Health Research Ethics Committee)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No