A Long-term Safety and Efficacy Study of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Subjects With Acne Vulgaris (GEDACNE-LT)
Condition(s) studied
Investigational drug(s) / intervention(s)
N-Acetyl-GED-0507-34-LEVO gel 5%: Each patient will apply a fingertip unit of N-Acetyl-GED-0507-34-Levo 5% gel as a thin film, once daily (OD), to the entire facial skin area and the affected skin areas of the trunk accessible for self-application (i.e., shoulders, upper back, and upper anterior chest) for up to 52 consecutive weeks.
Study summary
The clinical trial aims to test the long term safety of a new drug for acne vulgaris. The trial is performed to answer this question "Is it safe to apply the IMP daily for up to 52 weeks?". The trial aims to accurately measure the safety and the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be review the drug containing the active ingredient.
Participants will:
* Take drug every day for up to 52 weeks
* Visit the site once every 4 weeks for checkups and tests (where applicable) for the first 3 months of treatment, then visit the site every 13 weeks approximately for checkups and tests (where applicable).
* Record on a diary the daily/weekly applications of the study drug at home, and record any adverse events
Eligibility
Primary outcome measure(s)
- Incidence of AEs, TEAEs, ADRs, SAEs — From enrollment to the end of treatment at 52 weeks
Incidence of all Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) throughout the study; with special attention to local TEAEs concerning the treated facial area (local dermal safety), and systemic TEAEs - Frequency of discontinuation of treatment due to TEAEs — From enrollment to the end of treatment at 52 weeks
- Changes from baseline of systolic blood pressure during the study — From enrollment to the end of treatment at 52 weeks
mmHg - Changes from baseline of diastolic blood pressure during the study — From enrollment to the end of treatment at 52 weeks
mmHg - Changes from baseline of heart rate during the study — From enrollment to the end of treatment at 52 weeks
bpm - Physical examination during the study (height) — From enrollment to the end of treatment at 52 weeks
cm - Change from baseline of local tolerability- Application site signs/symptoms during the study — From enrollment to the end of treatment at 52 weeks
Local tolerability will be evaluated based on the following signs and symptoms: application site non-lesional erythema, application site exfoliation, and application site dryness, stinging, burning, itching. For each sign/symptom, a severity score will be assigned using a 4-point scale from 0 = absent to 3 = severe. Of note, only a sign/symptom occurring after the first application of study medication that requires additional therapy or discontinuation of treatment or judged from the Investigator as clinically significant will be documented as a TEAE. - Assessment of overall application site irritation over the study duration — From enrollment to the end of treatment at 52 weeks
- Physical examination during the study (weight) — From enrollment to the end of treatment at 52 weeks
kg - Physical examination during the study (BMI) — From enrollment to the end of treatment at 52 weeks
weight (kg) / \[height (m)\]² - Changes from baseline of RBC over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement 10E12/L - Changes from baseline of WBC over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L - Changes from baseline of Haematocrit over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement % - Changes from baseline of Haemoglobin over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement g/dl - Changes from baseline of MCV over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement fL - Changes from baseline of MCH over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement pg - Changes from baseline of MCHC over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement g/dL - Changes from baseline of Platelets over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L - Changes from baseline of neutrophils over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement 10E0/L - Changes from baseline of Lymphocytes over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L - Changes from baseline of Monocytes over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L - Changes from baseline of Eosinophils over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L - Changes from baseline of Basophils over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L - Changes from baseline of Differential blood count over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement % - Changes from baseline in AST (GOT) over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement U/L - Changes from baseline in ALT (GPT) over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement U/L - Changes from baseline in Triglycerides over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement mg/dl - Changes from baseline in Total cholesterol over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement mg/dl - Changes from baseline in HDL-C (high-density lipoprotein cholesterol) over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement mg/dl - Changes from baseline in LDL-C (low-density lipoprotein cholesterol) over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement mg/dl - Changes from baseline in Plasma glucose over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement mmol/L - Changes from baseline in HbA1c (glycated haemoglobin) over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement % - Changes from baseline in Insulinemia over the study duration — From enrollment to the end of treatment at 52 weeks
unit of measurement μU/mL - Changes from baseline in beta-HCG over the study duration — From enrollment to the end of treatment at 52 weeks
postive or negative
Trial sites (59)
| Facility | City | Region | Status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria Delle Marche | Ancona | AN | |
| Azienda USL Toscana Centro | Florence | FI | |
| IRCCS Ospedale Policlinico San Martino | Genova | GE | |
| Azienda Ospedaliero Universitaria Parma | Parma | PR | |
| Fondazione IRCCS Policlinico San Matteo | Pavia | PV | |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata | Roma | RM | |
| I.F.O. Istituti Fisioterapici Ospitalieri | Roma | RM | |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | |
| Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania | Catania | Italy | |
| University Hospital Of Ferrara | Ferrara | Italy | |
| Universita Degli Studi Di Modena E Reggio Emilia | Modena | Italy | |
| Azienda Ospedaliera Universitaria Federico II Di Napoli | Naples | Italy | |
| Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli | Naples | Italy | |
| Azienda Ospedaliero-Universitaria Maggiore Della Carita | Novara | Italy | |
| Azienda Ospedaliera di Padova | Padova | Italy | |
| Hospital Santa Maria Della Misericordia | Perugia | Italy | |
| Azienda USL Toscana Centro | Prato | Italy | |
| Fondazione Luigi Maria Monti | Roma | Italy | |
| Specderm Poznanska Sp. j. | Bialystok | Poland | |
| Vitamed Galaj I Cichomski Sp. j. | Bydgoszcz | Poland | |
| DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska | Chorzów | Poland | |
| NZOZ Przychodnia Specjalistyczna "A-DERM-SERWIS" | Częstochowa | Poland | |
| Centrum Badan Klinicznych Pi-House Sp. z o.o. | Gdansk | Poland | |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | |
| Provita Sp. z o.o. | Katowice | Poland | |
| Silmedic Sp. z o.o. | Katowice | Poland | |
| Vita Longa Sp. z o.o. | Katowice | Poland | |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. | Krakow | Poland | |
| Jagiellońskie Centrum Innowacji Sp. z o.o. | Krakow | Poland | |
| Amicare Sp. z o.o. S.K. | Lodz | Poland | |
| Dermed Centrum Medyczne Sp. z o.o. | Lodz | Poland | |
| Clinical Best Solutions Sp. z o.o. S.K. | Lublin | Poland | |
| Velocity Nova Sp. z o.o. | Lublin | Poland | |
| St-Inspire Sp. z o.o. | Mikołów | Poland | |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. | Nowa Sól | Poland | |
| Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. | Olsztyn | Poland | |
| Labderm Essence Sp. z o.o. | Ożarowice | Poland | |
| Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o. | Poznan | Poland | |
| Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie | Rzeszów | Poland | |
| Lukmed 2 Sp. z o.o. | Siedlce | Poland |
+ 19 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07389109 on ClinicalTrials.gov ↗ ← All trials in Spain