Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-25 @ 12:51 PM
NCT ID:
NCT04269395
Pre Assignment Details:
125 participants (87 in Methyl aminolevulinate hydrochloride (MAL) 16.8% cream group and 38 in vehicle cream group) from main study RD.06.SPR.112199 were enrolled and treated in this study. Study was terminated early as in main study, primary analysis did not show superiority of MAL 16.8% cream with DL-PDT over vehicle cream with DL-PDT as of participant complete response (CR), and the sponsor decided not to apply for marketing authorization for the MAL 16.8% cream in combination with DL-PDT.
Recruitment Details:
The study was conducted at 31 study centers in United States from 7 April 2020 to 1 September 2021. Participants who completed study RD.06.SPR.112199 (NCT04085367) and achieved complete response (CR) of all treated Actinic Keratosis (AKs) lesions at final visit of treatment, were continued to be followed in this for long-term follow-up (LTFU) study to assess recurrence.
Study:
NCT04269395
Study Brief:
Results Section:
NCT04269395