Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

Merete Haedersdal

Status and phase: Completed; Phase 2

Conditions: Striae Distensae

Treatments: Drug: Topical Tretinoin; Device: Fractional radiofrequency; Combination Product: Fractional radiofrequency and topical Tretinoin

Study type: Interventional

Funder types: Other

Identifiers

NCT05461755

SDRFTT

H-21038853 (Other Identifier)

2021-003153-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 4 patient groups

Combination therapy: Fractional radiofrequency and topical tretinoin

Experimental group

Description:

3 study treatments: at baseline, 1-month, 2-month with subsequent application of topical tretinoin. Home application of tretinoin between study visits

Treatment:

Combination Product: Fractional radiofrequency and topical Tretinoin

Fractional radiofrequency

Active Comparator group

Description:

3 study treatments: at baseline, 1-month, 2-month

Treatment:

Device: Fractional radiofrequency

Topical tretinoin

Active Comparator group

Description:

Application at study visits and home application between study visits

Treatment:

Drug: Topical Tretinoin

Untreated control

No Intervention group

Description:

No study treatments