GEDACNE 2
Research type
Research Study
Full title
A phase III study to assess efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel 5%, applied once daily for 12 weeks in patients with acne vulgaris (GEDACNE-2)
IRAS ID
1010206
Contact name
Salvatore Bellinvia
Contact email
Sponsor organisation
PPM Services S.A
Eudract number
2023-510341-19
ISRCTN Number
ISRCTN56244307
Research summary
This study is to assess the efficacy and safety of a gel treatment, in comparison to a placebo gel, applied once daily for 12 weeks in patients with Acne Vulgaris. Participants will be randomly assigned to either the treatment or placebo gel and they will not be made aware of which treatment they have been assigned to.
Male or females aged between >9 and <50 years of age suffering from Acne Vulgaris may be able to take part. The study will include up to 6 on-site visits over a duration of 16 weeks. The visits will last for 1-2 hours and will include some physical assessments and investigations. Patients will have an assessment of Acne symptoms and a collection of height, weight, and vital signs. Patients will also complete a questionnaire which will assess how their condition affects their daily life.
Study participants will be required to apply the Investigational Product (gel treatment, either active or placebo) themselves, once daily for the duration of the study period. In previous studies, the active treatment gel has been shown to be safe and well tolerated and a reduction of acne symptoms were found. This study will help gather further information on the effects of this gel and may offer an alternative treatment for patients suffering with Acne Vulgaris.
The study is taking place in multiple sites across 5 EU Countries, and 400 participants will be recruited. In the UK, 8 sites will be taking part, including both primary and secondary care NHS sites and some private research sites also.
The research will be funded by PPM Services P.A and will be conducted in the UK by LINK Medical Research, a Clinical Research Organisation.REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0547
Date of REC Opinion
8 Nov 2024
REC opinion
Further Information Favourable Opinion