WHO ICTRP trial

A CLINICAL STUDY TO EVALUATE THE LONG-TERM DERMAL SAFETY PROFILE OF 12-WEEKS…

EUCTR2017-003796-58-IT · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2017-003796-58-IT
Public title A CLINICAL STUDY TO EVALUATE THE LONG-TERM DERMAL SAFETY PROFILE OF 12-WEEKS TOPICAL ADMINISTRATION OF N-ACETYL-GED-0507-34-LEVO GEL 5% IN PATIENTS WITH FACIAL ACNE
Scientific title AN OPEN LABEL CLINICAL STUDY TO EVALUATE THE LONG-TERM DERMAL SAFETY PROFILE OF 12-WEEKS TOPICAL ADMINISTRATION OF N-ACETYL-GED-0507-34-LEVO GEL 5% IN PATIENTS WITH FACIAL ACNE - NAC-GED-0507 GEL 5% IN ACNE
Primary sponsor PPM SERVICES S.A.
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Italy
Conditions FACIAL ACNE MedDRA version: 20.0 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Interventions Product Name: N-Acetyl-GED-0507-34-Levo %5 gel Product Code: NAC-GED-0507 5% GEL Pharmaceutical Form: Gel CAS Number: 1190427-41-8 Current Sponsor code: N-ACETYL-GED-0507-34-LEVO Concentration unit: % (W/W) percent weight/weight…
Registration date Apr 11, 2020
Target size 25
Secondary IDs NAC-GED-0507-ACN-02-17
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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