GEDACNE LT
Research type
Research Study
Full title
A long-term safety and efficacy study of N-Acetyl-GED-0507-34-LEVO gel 5%, in subjects with acne vulgaris (GEDACNE-LT)
IRAS ID
1010207
Contact name
Salvatore Bellinvia
Contact email
Sponsor organisation
PPM Services S.A
Eudract number
2023-510342-24
ISRCTN Number
ISRCTN49040930
Research summary
This study is to assess the efficacy and safety of a gel, in the long term treatment (up to 52 weeks) in patients with Acne Vulgaris. The study is an open-label, non- comparative study which means that all participants will receive the treatment gel for a duration of the study.
Study participants will be required to apply the gel treatment themselves, once daily for a minimum of 12 weeks. From week 12- up to 52 weeks, patients’ treatment regime will be determined by an assessment of Acne symptoms.
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 8 on-site study visits, for a duration of up to 52 weeks. These visits would last for approximately 1-2 hours, of which will include some physical assessments and investigations; including an assessment of Acne symptoms and collection of height, weight, and vital signs. Blood samples will also be collected for safety analysis and a urine pregnancy test performed for females of childbearing potential. Participants will also complete a questionnaire which will assess how their condition affects their daily life.
In previous studies, the 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, 16 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.T
REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0552
Date of REC Opinion
30 Oct 2024
REC opinion
Further Information Favourable Opinion