WHO ICTRP trial

Clinical study to compare two creams with the active substance imiquimod and one…

EUCTR2016-000712-15-DE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2016-000712-15-DE
Public title Clinical study to compare two creams with the active substance imiquimod and one cream without active substance for patients with actinic keratosis
Scientific title Double-blind, randomised clinical study comparing efficacy and safety of Imiquimod 5% Cream (Test) vs. Aldara® 5% Cream (Reference) vs. Vehicle in patients with actinic keratosis
Primary sponsor Dermapharm AG
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Germany
Conditions Actinic keratosis MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue…
Interventions Product Name: Imiquimod 5% cream Pharmaceutical Form: Cream INN or Proposed INN: IMIQUIMOD CAS Number: 99011-02-6 Current Sponsor code: n.a. Other descriptive name: Imiquimod Concentration unit: % (W/W) percent weight/weight Concentration…
Registration date Oct 14, 2016
Target size 426
Secondary IDs 16-04/Imi-C
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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