Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 6:02 AM
Study NCT ID:
NCT07384195
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Patients With Acne Vulgaris (GEDACNE-1)
Sponsor:
PPM Services S.A.
Organization:
Study Overview
Official 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-1)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEDACNE-1
Brief Summary:
The clinical trial aims to test a new drug for acne vulgaris. The trial is performed to answer this question "Is it possible to reduce the number of skin lesions on your face/trunk, after daily applications for 12 consecutive weeks of a new drug?". The trial aims to accurately measure the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be randomly assigned to one of the following treatments:
* Study drug 1: test item, containing active ingredient
* Study drug 2: a preparation not containing any active ingredient (vehicle). Researchers will compare active to vehicle to see if there are differences in the efficacy.
Participants will:
* Apply drug or a placebo every day for 12 weeks
* Visit the site once every 4 weeks for checkups and tests (where applicable)
* Record on a diary the daily applications of the study drug at home, and record any adverse events
* Study drug 1: test item, containing active ingredient
* Study drug 2: a preparation not containing any active ingredient (vehicle). Researchers will compare active to vehicle to see if there are differences in the efficacy.
Participants will:
* Apply drug or a placebo every day for 12 weeks
* Visit the site once every 4 weeks for checkups and tests (where applicable)
* Record on a diary the daily applications of the study drug at home, and record any adverse events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-510339-12-00 | CTIS | None | View |