Striae DistensaePhase 2NCT05461755
Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin
A Phase 2 study testing Fractional radiofrequency and topical Tretinoin, Topical Tretinoin and Fractional radiofrequency in people with Striae Distensae, run by Merete Haedersdal at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Striae Distensae
- What is being tested?
- Fractional radiofrequency and topical Tretinoin, Topical Tretinoin and Fractional radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Nov 2022to 5 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin: An Intra-individual Study With Blinded Outcome Assessment
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
- Being tested
- Fractional radiofrequency and topical Tretinoin, Topical Tretinoin, Fractional radiofrequency
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional radiofrequency and topical TretinoinCombination product
Also called VenusViva MD, Retirides
Treatment of striae with fractional radiofrequency and topical tretinoin in combination
Topical TretinoinDrug
Also called Retirides
Treatment of striae with topical tretinoin alone
Fractional radiofrequencyDevice
Also called VenusViva MD
Treatment of striae with fractional radiofrequency alone
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: Fractional radiofrequency and topical Tretinoin |
| Fractional radiofrequency | Active comparator | 3 study treatments: at baseline, 1-month, 2-month Receives: Device: Fractional radiofrequency |
| Topical tretinoin | Active comparator | Application at study visits and home application between study visits Receives: Drug: Topical Tretinoin |
| Untreated control | No intervention | No study treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up
Secondary outcomes (4)
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)
Measured: Baseline - 20 weeks follow-up (12 weeks after last treatment)
Evaluation of striae with imaging
Assessment of tissue interaction with imaging techniques
Measured: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up
Subject satisfaction
Likert scale for subject satisfaction
Measured: Baseline - 20 weeks follow-up (12 weeks after last treatment)
Safety: LSR and AE/AR
Collection and registration of local skin reactions and AE/AR
Measured: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start22 Nov 2022
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Striae DistensaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merete Haedersdal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merete Haedersdal, Bispebjerg Hospital
- Investigators
- Merete Haedersdal, MD PhD DMSc, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461755
- Sponsor's protocol ID
- SDRFTT
- Other IDs
- 2021-003153-39, H-21038853
- Status last verified
- Aug 2023
- First submitted
- 14 Jul 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grove GL, Karmisholt KE, Philipsen PA, Bjerring P, Haedersdal M. Treatment of striae albae with combination of fractional radiofrequency and topical tretinoin: A randomized controlled trial. Lasers Med Sci. 2026 Jul 31;41(1):173. doi: 10.1007/s10103-026-04975-5.
PubMed 42533163
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin: An Intra-individual Study With Blinded Outcome Assessment
- ClinicalTrials.gov ID
- NCT05461755
- Acronym / sponsor ID
- SDRFTT
- Conditions
- Striae Distensae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merete HaedersdalUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Combination therapy: Fractional radiofrequency and topical tretinoin | Experimental | Combination Product: Fractional radiofrequency and topical Tretinoin3 study treatments: at baseline, 1-month, 2-month with subsequent application of topical tretinoin. Home application of tretinoin between study visits |
| Fractional radiofrequency | Active comparator | Device: Fractional radiofrequency3 study treatments: at baseline, 1-month, 2-month |
| Topical tretinoin | Active comparator | Drug: Topical TretinoinApplication at study visits and home application between study visits |
| Untreated control | No intervention | –No study treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional radiofrequency and topical TretinoinAlso: VenusViva MD, RetiridesTreatment of striae with fractional radiofrequency and topical tretinoin in combination | Combination product | Combination therapy: Fractional radiofrequency and topical tretinoin |
| Topical TretinoinAlso: RetiridesTreatment of striae with topical tretinoin alone | Drug | Topical tretinoin |
| Fractional radiofrequencyAlso: VenusViva MDTreatment of striae with fractional radiofrequency alone | Device | Fractional radiofrequency |
Primary outcome
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)
4 secondary outcomes
Evaluation of striae with POSAS
Time frame: Baseline - 20 weeks follow-up (12 weeks after last treatment)
Evaluation of striae with imaging
Time frame: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up
Subject satisfaction
Time frame: Baseline - 20 weeks follow-up (12 weeks after last treatment)
Safety: LSR and AE/AR
Time frame: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 42533163Grove GL, Karmisholt KE, Philipsen PA, Bjerring P, Haedersdal M. Treatment of striae albae with combination of fractional radiofrequency and topical tretinoin: A randomized controlled trial. Lasers Med Sci. 2026 Jul 31;41(1):173. doi: 10.1007/s10103-026-04975-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Haedersdal, MD PhD DMSc principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fractional radiofrequency and topical Tretinoin, Topical Tretinoin and Fractional radiofrequency in people with Striae Distensae, run by Merete Haedersdal at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in appearance of striae with GAIS (time frame: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.