Clinical trial NCT05461755: Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin
Official title: Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin: An Intra-individual Study With Blinded Outcome Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Striae Distensae
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement in appearance of striae with GAIS
timeFrame: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up
Secondary outcomes:
measure: Evaluation of striae with POSAS
timeFrame: Baseline - 20 weeks follow-up (12 weeks after last treatment)
measure: Evaluation of striae with imaging
timeFrame: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up
measure: Subject satisfaction
timeFrame: Baseline - 20 weeks follow-up (12 weeks after last treatment)
measure: Safety: LSR and AE/AR
timeFrame: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Dermatology, Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Haedersdal, MD PhD DMSc
role: PRINCIPAL_INVESTIGATOR
References: