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Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

Sponsor
Merete Haedersdal (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05461755
Collaborator
(none)
20
Enrollment
1
Location
4
Arms
8
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Fractional radiofrequency and topical Tretinoin
  • Drug: Topical Tretinoin
  • Device: Fractional radiofrequency
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Single (Outcomes Assessor)
Masking Description:
Primary outcome assessment is blinded
Primary Purpose:
Treatment
Official Title:
Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin: An Intra-individual Study With Blinded Outcome Assessment
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    2. Evaluation of striae with imaging [Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up]

      Assessment of tissue interaction with imaging techniques

    3. Subject satisfaction [Baseline - 20 weeks follow-up (12 weeks after last treatment)]

      Likert scale for subject satisfaction

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Dermatology, Bispebjerg Hospital Copenhagen Denmark 2400

    Sponsors and Collaborators

    • Merete Haedersdal

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merete Haedersdal, Consultant in Dermatology, Clinical Professor, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT05461755
    Other Study ID Numbers:
    • SDRFTT
    • 2021-003153-39
    • H-21038853
    First Posted:
    Jul 18, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Striae Distensae
    Tretinoin

    Study Results

    No Results Posted as of Jul 18, 2022