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NCT03377231
Prevention and Treatment of Stretch Marks With Stratamark™
Phase 4 trial testing Stratamark® in Stretch Mark in 272 participants. Completed in 16 May 2016.
16 May 2016
Quick facts
| Lead sponsor | Stratpharma AG |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 272 |
| Start date | 11 July 2013 |
| Primary completion | 16 May 2016 |
| Estimated completion | 16 May 2016 |
Drugs / interventions tested
- Stratamark®
Conditions studied
- Stretch Mark — all drugs for Stretch Mark →
Sponsor
Stratpharma AG — full company profile →
Who can join
18 and older, female only, with Stretch Mark. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Stretch marks (striae distensae) are a form of scarring that is a natural result of pregnancy, obesity and in some instances occur due to puberty or steroid use. For some people, the stretch marks do not cause a problem, but in many circumstances they can cause physical symptoms such as itchiness, tenderness and pain. For many people stretch marks are also embarrassing and can have detrimental effects on a patient's mood and self-esteem. Stretch marks that result from pregnancy most commonly occur on the abdomen, breasts and thighs. Topical silicone gel was developed nearly thirty years ago to be used in the treatment of widespread hypertrophic scars (abnormal scars, which may be red or raised/depressed itchy or painful). Since this time it has been used successfully on most scar types. . Since stretch marks are a form of scarring it is thought that topical silicone gel may be helpful for this scar type also. Stratamark™ has been developed using different forms of silicone polymers, in a gel format, that dries to form a very thin and flexible silicone gel sheet making it a convenient therapy for the treatment and prevention of stretch marks. The aim of this clinical research study is to prove or disprove the efficacy, safety and tolerability of Stratamark™ in the prevention and treatment of stretch marks. In addition, the knowledge gained from this study may be of benefit to many future patients
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03377231
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Related trials
Other Stratpharma AG trials
Trials by the same sponsor.
- NCT05810194 — Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis · completed
- NCT05614557 — Impact of Silicon-based Formulations on Wound Healing of Laser-induced Microscopic Skin Lesions · NA · completed
- NCT05553392 — StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis · NA · terminated
- NCT05432154 — An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis · NA · completed
- NCT05396261 — a Flexible Wound Dressing for the Management of Genital Skin Conditions · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03377231 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stratpharma AG
- Last refreshed: 20 December 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03377231.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing