Viewing Study NCT05910450



Ignite Creation Date: 2024-05-06 @ 7:10 PM
Last Modification Date: 2024-10-26 @ 3:01 PM
Study NCT ID: NCT05910450
Status: RECRUITING
Last Update Posted: 2024-02-12
First Post: 2023-06-06

Brief Title: A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
Sponsor: Cassiopea SpA
Organization: Cassiopea SpA

Study Overview

Official Title: A 6-month Phase 3 Multicenter Prospective Randomized Double-Blind Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topically Applied Clascoterone Solution for the Treatment of Androgenetic Alopecia in Males Followed by a 6-month Single-Blind Treatment With Clascoterone or Vehicle Solution
Status: RECRUITING
Status Verified Date: 2024-02
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: SCALP1
Brief Summary: The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects

Within this study the Clascoterone solution will be compared to a placebo

The study has 2 parts

Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months

Part 2 will see the long-term safety and efficacy of the Clascoterone solution compared to placebo for additional 6 months in subjects defined as responders in Part 1 A responder is defined as someone who have responded to the study drug based on research data

Part 1 of the study is double-blind meaning that neither the subject nor the study doctor knows which treatment subject is receiving Part 2 of the study is single-blind and only the study doctor doing the study knows which treatment subject is receiving

Part 1 of the study will start with baseline visit during which subjects will be randomly assigned by chance in ratio 21 to apply either Clascoterone or placebo solution to their balding areas of the scalp Subjects will have 5 clinic visits and 2 follow-up phone calls during 6 months of Part 1 duration Subjects identified as Part 1 responders at Month 6 visit will be again randomly assigned in ratio 21 to receive either study drug or placebo

Part 2 of the study will consist of 2 additional clinic visits and treatment will last for further 6 months

Each subject will have also an end of study visit one month after the study drug treatment has been completed or discontinued it will be one month after end of Part 1 for not responder subjects

For those subjects who complete the whole study Part 1 and Part 2 the total duration of the study will be about 14 months with 12 months of treatment with a total of eight clinic visits and two phone calls

Subjects taking part in this study will have the medical tests or procedures described below

They will be asked about their previous medical history and current medications
A brief physical examination will be performed
Vital signs weight and height will be measured
Electrocardiograms will be performed
Subjects scalp will be checked for any signs of irritation
Two different types of photos will be taken during this study global photos ie general photos of the subjects scalp and macro photos ie close up photos of a region of the subjects scalp Global photos will be taken to help the subject and the study doctor to assess whether there has been a change in subjects hair growth Macro photos will be used to count the number of hairs in a region of the subjects scalp and measure other properties of the hair hair width and hair darkness
Blood draws and urine sample collection for safety laboratory tests
Subject will be asked to complete on site the following two questionnaires

Cosmetic Evaluation - a couple of cosmetic questions on acceptability and how easy the study drug is to use
Male Androgenetic Alopecia Questionnaire - some questions about subjects hair assessment

Eligible subjects will be given a supply of the study drug and shown how to use and store it The first study drug dose will be applied at the clinic under the supervision of the study staff Subjects will be instructed to apply about 15 ml of study drug with a dropper to the balding areas of the scalp on the vertex and the temples twice daily once in the morning and once in the evening

Subjects will be asked to bring back all used containers of study drug and all unused study drug to each study visit Subjects will also be given a diary shown what things have to be recorded on it and asked to bring back the completed diary to the study center at each visit
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None