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Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

Primary Purpose

Striae Distensae

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Fractional radiofrequency and topical Tretinoin

Topical Tretinoin

Fractional radiofrequency

About this trial

This is an interventional treatment trial for Striae Distensae

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Dermatology, Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Combination therapy: Fractional radiofrequency and topical tretinoin

Fractional radiofrequency

Topical tretinoin

Untreated control

Arm Description

3 study treatments: at baseline, 1-month, 2-month with subsequent application of topical tretinoin. Home application of tretinoin between study visits

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

Application at study visits and home application between study visits

No study treatments

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Evaluation of striae with imaging

Assessment of tissue interaction with imaging techniques

Subject satisfaction

Likert scale for subject satisfaction

Safety: LSR and AE/AR

Collection and registration of local skin reactions and AE/AR

Full Information

NCT ID

NCT05461755

First Posted

July 14, 2022

Last Updated

August 9, 2023

Sponsor

Merete Haedersdal

1. Study Identification

Unique Protocol Identification Number

NCT05461755

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

November 22, 2022 (Actual)

Primary Completion Date

July 5, 2023 (Actual)

Study Completion Date

July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Merete Haedersdal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Striae Distensae

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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.

Masking

Outcomes Assessor

Masking Description

Primary outcome assessment is blinded

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combination therapy: Fractional radiofrequency and topical tretinoin

Arm Type

Experimental

Arm Description

3 study treatments: at baseline, 1-month, 2-month with subsequent application of topical tretinoin. Home application of tretinoin between study visits

Arm Title

Fractional radiofrequency

Arm Type

Active Comparator

Arm Description

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

Arm Title

Topical tretinoin

Arm Type

Active Comparator

Arm Description

Application at study visits and home application between study visits

Arm Title

Untreated control

Arm Type

No Intervention

Arm Description

No study treatments

Intervention Type

Combination Product

Intervention Name(s)

Fractional radiofrequency and topical Tretinoin

Other Intervention Name(s)

VenusViva MD, Retirides

Intervention Description

Treatment of striae with fractional radiofrequency and topical tretinoin in combination

Intervention Type

Drug

Intervention Name(s)

Topical Tretinoin

Other Intervention Name(s)

Retirides

Intervention Description

Treatment of striae with topical tretinoin alone

Intervention Type

Device

Intervention Name(s)

Fractional radiofrequency

Other Intervention Name(s)

VenusViva MD

Intervention Description

Treatment of striae with fractional radiofrequency alone

Primary Outcome Measure Information:

Title

Improvement in appearance of striae with GAIS

Description

Standardized clinical photos from baseline and follow-up comparing treatments and assessed by blinded evaluator on the Global Aesthetic Improvement Scale (GAIS)

Time Frame

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

Secondary Outcome Measure Information:

Title

Evaluation of striae with POSAS

Description

Standardized on-site assessment comparing treatments assessed by the subject and a blinded evaluator on the Patient-Observer Scar Assessment Scale (POSAS)

Time Frame

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

Title

Evaluation of striae with imaging

Description

Assessment of tissue interaction with imaging techniques

Time Frame

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

Title

Subject satisfaction

Description

Likert scale for subject satisfaction

Time Frame

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

Title

Safety: LSR and AE/AR

Description

Collection and registration of local skin reactions and AE/AR

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Merete Haedersdal, MD PhD DMSc

Organizational Affiliation

Bispebjerg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology, Bispebjerg Hospital

City

Copenhagen

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

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