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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003153-39 | EudraCT Number | ||
| H-21038853 | Other Identifier | The Regional Health Research Ethics Committee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Fractional radiofrequency | Active Comparator | 3 study treatments: at baseline, 1-month, 2-month |
|
| Topical tretinoin | Active Comparator | Application at study visits and home application between study visits |
|
| Untreated control | No Intervention | No study treatments |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional radiofrequency and topical Tretinoin | Combination Product | Treatment of striae with fractional radiofrequency and topical tretinoin in combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline - 20 weeks follow-up (12 weeks after last treatment) |
| Evaluation of striae with imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merete Haedersdal, MD PhD DMSc | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 |
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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.
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Primary outcome assessment is blinded
|
| Topical Tretinoin | Drug | Treatment of striae with topical tretinoin alone |
|
|
| Fractional radiofrequency | Device | Treatment of striae with fractional radiofrequency alone |
|
|
Assessment of tissue interaction with imaging techniques |
| Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up |
| Subject satisfaction | Likert scale for subject satisfaction | 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 | Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up |
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |