ELAPR002 implant – safety and efficacy, v1
Research type
Research Study
Full title
A randomized, within-subject, placebo-controlled, single-blind study to evaluate the efficacy of ELAPR002f and ELAPR002g in women with striae distensae (SD) alba (HMR code: 14-502)
IRAS ID
184812
Contact name
Frans van den Berg
Contact email
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
ELAPR002 is an experimental new implant for improving the appearance of stretch marks. Stretch marks are formed when the skin suddenly stretches and the middle layer of the skin (the dermis) is damaged. We hope ELAPR002 will improve the appearance of stretch marks by helping the dermis to repair.
ELAPR002 contains 2 substances that are found in the dermis of the skin: tropoelastin and hyaluronic acid. Tropoelastin forms another substance called elastin, which gives the skin its stretchiness. Elastin is lost or damaged when stretch marks form, and the body can’t replace it. Hyaluronic acid attaches or ‘binds’ to water in the skin, increasing skin volume or plumpness. We hope ELAPR002 will work by repairing lost or damaged elastin, promoting skin repair, and ‘filling-out’ stretch marks. ELAPR002 is not a medical device.
Current treatments for stretch marks include: ‘injuring’ the skin using lasers or by pricking it many times with needles or injecting man-made substances to promote skin repair; or giving many injections of vitamins, nutrients and water. Because the substances in ELAPR002 are identical to those found in human skin, we hope ELAPR002 will be more effective than current treatments in improving the appearance of stretch marks, and cause fewer side effects.
This study will include 2 groups of 9 healthy women, aged 30–55 years. In each group volunteers will receive a placebo implant injected into a stretch mark on one side of their body and ELAPR002 injected into a stretch mark on the other side. The 2 groups will receive different combinations of tropoelastin and hyaluronic acid.
Participants will take up to 4 months to finish the study. They’ll make 6 outpatient visits.A medical device company (Elastagen Pty Ltd) is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
15/NI/0139
Date of REC Opinion
30 Jul 2015
REC opinion
Further Information Favourable Opinion