ELAPR002 implant for acne scars – 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 males and females with atrophic rolling acne scars. (HMR code: 16-505)
IRAS ID
215324
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Elastagen Pty Ltd
Eudract number
2000-123456-78
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
ELAPR002 is an experimental new implant for improving the appearance of acne scars. Acne is caused by pores in the skin becoming clogged and infected with bacteria. In some people, acne damages the skin, leaving scars that remain after their acne has cleared up. We hope the study implant will improve the appearance of acne scars by helping the skin to repair itself.\n\nELAPR002 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 scars form. 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 improving the appearance of acne scars. ELAPR002 is not a medical device.\n\nBecause the substances in ELAPR002 are identical to those found in human skin, we hope that it will be more effective than current treatments in improving the appearance of scars, and cause fewer side effects.\n\nThis study will include 2 groups of 15 healthy men and women, aged 18–55 years. In each group, volunteers will receive a placebo implant and ELAPR002 injected into areas of acne scarring, one on each side of their face. At least 5 volunteers in each group will also receive injections into areas of scarring on their back or chest. The 2 groups will receive different combinations of tropoelastin and hyaluronic acid. \n\nParticipants will take up to 7 months to finish the study. They’ll make 8 outpatient visits.\n\nA medical device company (Elastagen Pty Ltd) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
16/NI/0216
Date of REC Opinion
8 Nov 2016
REC opinion
Further Information Favourable Opinion