Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

NCT05461755 | Completed Phase 2 DMC

• 3 other identifiers: SDRFTT2021-003153-39H-21038853
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Striae Distensae

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of striae with POSAS

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

• Evaluation of striae with imaging

  Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up

• Subject satisfaction

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

• Safety: LSR and AE/AR

  Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up

Study Arms (4)

Combination therapy: Fractional radiofrequency and topical tretinoin

EXPERIMENTAL

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

Fractional radiofrequency

ACTIVE COMPARATOR

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

Device: Fractional radiofrequency

Topical tretinoin

ACTIVE COMPARATOR

Application at study visits and home application between study visits

Drug: Topical Tretinoin

Untreated control

NO INTERVENTION

No study treatments

Interventions

Fractional radiofrequency and topical Tretinoin COMBINATION_PRODUCT

Treatment of striae with fractional radiofrequency and topical tretinoin in combination

Also known as: VenusViva MD, Retirides

Combination therapy: Fractional radiofrequency and topical tretinoin

Topical Tretinoin DRUG

Treatment of striae with topical tretinoin alone

Also known as: Retirides

Topical tretinoin

Fractional radiofrequency DEVICE

Treatment of striae with fractional radiofrequency alone

Also known as: VenusViva MD

Fractional radiofrequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merete Haedersdal: lead

Study Sites (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Striae Distensae

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Merete Haedersdal, MD PhD DMSc

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcome assessment is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Dermatology, Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: November 22, 2022
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

DK (1)