Skip to main content
OpenTrials
Completed

NCT Number: NCT05461755

Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Striae Distensae Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Dermatology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has provided written informed consent
  • Subject is 18 years of age or older
  • Fitzpatrick skin type I-III
  • Striae albae (grade II-IV) ≥1 year of age and ≥ 4 lesions with a length of ≥ 2 cm each
  • 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

  • Severe concurrent conditions such as cardiac disorders or poorly regulated diabetes
  • History of skin disorders such as keloids, abnormal wound healing or very fragile skin
  • History of heat-stimulated disease such as herpes simplex in the treatment area
  • History of bleeding coagulopathies or use of anti-coagulants
  • Surgery in the treatment area past 6 months or before complete healing
  • Tattoo or permanent make-up in treatment area
  • Excessively tanned skin from sun, tanning bed or tanning creams last 2 weeks
  • Dermabrasion, resurfacing, soft tissue/fat injections or chemical peeling in treatment area the past 3 months
  • Abnormal skin (e.g. rash, infection, dermatitis) at the treatment area at the time of inclusion
  • Treatment with Isotretinoin within the past 6 months
  • Use of non-steroidal anti-inflammatory drugs 1 week prior to treatment
  • Known allergies to tretinoin or lidocaine/prilocaine
  • History of cancer including pre-malignant moles
  • Impaired immune system due to immunosuppressive disease or medication
  • Electronic device implant
  • Any implantable metal piece or permanent chemical substance in treatment area
  • If female; lactating, pregnant or planning on becoming pregnant during the study
  • Non-eligibility at the discretion of the investigator

Treatment and study plan

Fractional radiofrequency and topical Tretinoin

Combination Product

Treatment of striae with fractional radiofrequency and topical tretinoin in combination

Other names: VenusViva MD, Retirides

Topical Tretinoin

Drug

Treatment of striae with topical tretinoin alone

Other names: Retirides

Fractional radiofrequency

Device

Treatment of striae with fractional radiofrequency alone

Other names: VenusViva MD

Primary outcomes

  1. Improvement in appearance of striae with GAIS

    Time frame: 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 outcomes

  1. Evaluation of striae with POSAS

    Time frame: 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

    Time frame: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up

    Assessment of tissue interaction with imaging techniques

  3. Subject satisfaction

    Time frame: Baseline - 20 weeks follow-up (12 weeks after last treatment)

    Likert scale for subject satisfaction

  4. Safety: LSR and AE/AR

    Time frame: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up

    Collection and registration of local skin reactions and AE/AR

Sponsors and collaborators

Lead sponsor

Merete Haedersdal

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.