Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

Striae Distensae Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461755
• Other study ID #: SDRFTT
• Secondary ID: 2021-003153-39H-
• Status: Completed
• Phase: Phase 2
• Start date: November 22, 2022
• Est. completion date: July 5, 2023

Study information

• Verified date: August 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Striae Distensae

Intervention

Combination Product:
• Fractional radiofrequency and topical Tretinoin
Treatment of striae with fractional radiofrequency and topical tretinoin in combination

Drug:
• Topical Tretinoin
Treatment of striae with topical tretinoin alone

Device:
• Fractional radiofrequency
Treatment of striae with fractional radiofrequency alone

Locations

Country	Name	City	State
Denmark	Department of Dermatology, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Merete Haedersdal

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Evaluation of striae with imaging	Assessment of tissue interaction with imaging techniques	Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up
Secondary	Subject satisfaction	Likert scale for subject satisfaction	Baseline - 20 weeks follow-up (12 weeks after last treatment)
Secondary	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