E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057065 |
E.1.2 | Term | Striae distensae |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The study aims to explore the potential of combination therapy with fractional radiofrequency and topical tretinoin for treatment and overall improvement of striae albae. The investigators also aim to assess subject satisfaction, local skin responses and adverse effects/reactions in relation to the radiofrequency and topical tretinoin treatments, alone and in combination. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Subject has provided written informed consent 2) Subject is 18 years of age or older 3) Fitzpatrick skin type I-III 4) Striae albae (grade II-IV) ≥1 year of age and ≥ 4 lesions with a length of ≥ 2 cm each 5) Women of childbearing potential are not pregnant (confirmed by a negative u-HCG prior to study treatments) and use a safe contraceptive method prior during treatment.
|
|
E.4 | Principal exclusion criteria |
1) Severe concurrent conditions such as cardiac disorders or poorly regulated diabetes 2) History of skin disorders such as keloids, abnormal wound heling or very fragile skin 3) History of heat-stimulated disease such as herpes simplex in the treatment area 4) History of bleeding coagulopathies or use of anti-coagulants 5) Surgery in the treatment area past 6 months or before complete healing 6) Tattoo or permanent make-up in treatment area 7) Excessively tanned skin from sun, tanning bed or tanning creams last 2 weeks 8) Dermabrasion, resurfacing, soft tissue/fat injections or chemical peeling in treatment area the past 3 months 9) Abnormal skin (e.g. rash, infection, dermatitis) at the treatment area at the time of inclusion 10) Treatment with Isotretinoin within the past 6 months 11) Use of non-steroidal anti-inflammatory drugs 1 week prior to treatment 12) Known allergies to tretinoin or lidocaine/prilocaine 13) History of cancer including pre-malignant moles 14) Impaired immune system due to immunosuppressive disease or medication 15) Electronic device implant 16) Any implantable metal piece or permanent chemical substance in treatment area 17) If female; lactating, pregnant or planning on becoming pregnant during the study 18) Non-eligibility at the discretion of the investigator (e.g. strong reaction to study-device based on test spot, non-compliance, unavailability or other reasons the subject is not believed to be able to comply with the clinical trial protocol) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in appearance of striae by standardized clinical photos, assessed by a blinded evaluator, comparing treatments with topical tretinoin and radiofrequency alone and in combination |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline compared to last follow-up,12 weeks after 3rd treatment. |
|
E.5.2 | Secondary end point(s) |
o Improvement in appearance of striae by standardized on-site assessment comparing treatments with topical tretinoin and radiofrequency alone and in combination o Evaluation of striae via standardized 3D photographic analysis o Evaluation of striae with OCT-scan o Evaluation of striae with US-imaging o Subject satisfaction of topical tretinoin and radiofrequency treatments on a 5-point Likert scale o Procedure-related discomfort during treatment o Local skin response following treatment o Treatment-related AE/AR |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline (treatment 1), week 1 (telephone), week 4 (treatment 2) , week 8 (treatment 3) and week 20 (12 week follow-up) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Blinded outcome assessment on primary endpoint |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS However, subjects may be terminated or withdrawn from the study for the following reasons: o Withdraws consent – meaning that subject chooses not to further participate in the study o Change in health status and/or medications that in the physician’s opinion would conflict with the study
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |