Not recruiting

Study on the Effectiveness and Safety of Clascoterone Solution for Treating Male Pattern Hair Loss

Fast replyInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Androgenetic Alopecia, commonly known as male pattern hair loss. The treatment being tested is a topical solution called Clascoterone, also known by its code name CB-03-01. This solution is applied directly to the skin and is designed to help with hair loss in men.

The purpose of the study is to evaluate how effective and safe the Clascoterone solution is in treating male pattern hair loss. The study will last for a total of 12 months. During the first 6 months, participants will be randomly assigned to use either the Clascoterone solution or a vehicle solution, which does not contain the active ingredient. This part of the study is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment. After this period, all participants will use the Clascoterone solution for another 6 months in a single-blind phase, where only the researchers know the treatment details.

Participants will apply the solution twice a day and will be monitored for changes in hair growth and any side effects. The study aims to provide insights into the potential benefits of Clascoterone for men experiencing hair loss.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study initiation
Upon joining the study, the participant will be informed about its course and objectives. The study aims to evaluate the efficacy and safety of clascoterone solution in the treatment of androgenetic alopecia in men.
The participant must provide written consent to participate in the study and meet certain criteria, such as being over 18 years of age and having androgenetic alopecia in specific areas of the head.
Step 2
First part
For the first 6 months, the participant applies the clascoterone solution or the control solution twice daily (BID) to the scalp.
The purpose of this part of the study is to assess changes in hair coverage and the participant's subjective assessment of hair coverage after 6 months.
Step 3
Second part
After completing the first part of the study, the participant enters the second, 6-month phase, in which they apply the clascoterone solution or the control solution in a single-blind fashion.
During this phase, the treatment's efficacy and safety are continued.
Step 4
Follow-up visits
The participant is required to attend regular follow-up clinic visits to assess treatment progress and potential side effects.
These visits are crucial for monitoring the effectiveness and safety of the treatment.
Step 5
End of trial
After the 12-month study period, the participant stops using the solution and undergoes a final evaluation of treatment outcomes.
The final study results are analyzed to assess the long-term effectiveness and safety of the clascoterone solution.

Who can join the trial?

8 criteria

The patient must be male, at least 18 years of age.
The patient must provide written consent to participate in the study.
The patient must have mild to moderate androgenetic alopecia at the temples and vertex, rated as III vertex to V on the Norwood-Hamilton scale, with a history of ongoing hair loss.
The patient must be willing to maintain the same hairstyle, hair length, and hair color throughout the study.
The patient must be willing to follow the study instructions at home and return to the clinic for required visits.
The patient must agree to continue the same shampooing frequency and use of other general hair care products throughout the study.
The patient must agree to maintain the same dietary and supplementation pattern.
Patients who are sexually active with a partner and are not surgically sterile (vasectomy performed at least 6 months prior to treatment) must agree to use an acceptable form of birth control, as described in the consent form. For patients, acceptable forms of contraception include condoms and spermicide in combination with other forms of female contraception. For women, acceptable methods (Pearl Index <1%) would include the use of implants, injectables, combined oral contraceptives, certain intrauterine devices, or being postmenopausal (defined as the absence of menstrual periods for more than 12 consecutive months in women aged 50 years or older), being surgically sterile (hysterectomy, bilateral tubal ligation [at least 6 months prior], or bilateral oophorectomy).

Who cannot join the trial?

6 criteria

Individuals who are not adult males are not permitted to participate in the study.
Individuals with other health problems that may affect the study results are not permitted to participate.
Individuals taking other medications or therapies that may interfere with the study substance are not permitted to participate.
Individuals who cannot attend regular follow-up appointments are not permitted to participate in the study.
Individuals who are allergic to the components of the study substance are not permitted to participate.
Individuals who do not consent to participate in the study are not permitted to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Charite Research Organisation GmbH
Verified
Berlin, Germany
Diamond Clinic Sp. z o.o.
Responsive
Cracow, Poland
Not recruiting
Provita Sp. z o.o.
Verified
Katowice, Poland

Trial locations

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Investigated drugs

Clascoterone is a topical solution that is being studied for the treatment of androgenetic alopecia in men. It works by inhibiting the effects of hormones that can contribute to hair loss. A clinical trial is evaluating the effectiveness and safety of this medication over a six-month period.

Clascoterone

What is already known about the treatment

Clascoterone – Clascoterone is a topical medication in the form of a solution applied directly to the scalp. It is currently undergoing Phase 3 clinical trials to evaluate its efficacy and safety in the treatment of androgenetic alopecia in men. Its primary therapeutic indications include the treatment of androgenetic alopecia. Clascoterone's mechanism of action is to block androgen receptors in the skin, reducing the effect of hormones on hair follicles. It is classified as a topical antiandrogen.

Investigated diseases

Androgenetic alopecia – This is the most common form of hair loss in adult men and women, characterized by a gradual thinning of scalp hair. This process is associated with the action of androgen hormones and genetic predisposition. In men, it typically begins with a receding hairline on the forehead and thinning on the crown. In women, it manifests as even thinning of hair across the entire scalp, rarely leading to complete baldness. The disease progresses slowly, and its severity can vary from person to person. Early symptoms may be subtle, but become more noticeable over time.