Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

Launched by SAMSON CLINICAL OPERATIONS PTY LTD · Apr 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called minoxidil, specifically in the form of tablets that dissolve under the tongue, to see if it can help men with male pattern baldness, also known as androgenetic alopecia. The trial will last for about 32 weeks and will involve taking the tablets twice a day. The main goal is to find out if these tablets can increase hair growth in men who have thinning hair or bald spots on the top of their heads.

To participate, men must be at least 18 years old and have specific types of hair loss classified as Norwood-Hamilton Type III, IV, V, or VI. They should also be in good health and agree to follow the study rules, which include attending regular visits and keeping their hair styled and colored the same throughout the trial. There are several health conditions and recent treatments that could exclude someone from participating, so it’s important for interested individuals to discuss their health history with the study team. Participants can expect close monitoring of their health and hair growth throughout the study, and they will receive more information about what is involved before they decide to join.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Cisgender males of at least 18 years of age (inclusive) at the time of Screening.
• • In good general health in the opinion of the Investigator.
• • Presence of androgenetic alopecia with hair density reduction in the centroparietal area or vertex of the scalp classified as Norwood-Hamilton Type III vertex, IV, V or VI.
• • Willing and able to attend all study visits and comply with treatment plan and required study procedures including scalp tattooing and hair trimming.
• • Willing to maintain the same hair style, hair colour, and hair length in non-balding areas.
• • Able to comprehend and willing to sign and date a written patient informed consent form (PICF).
• Exclusion Criteria:
• • Norwood-Hamilton Type IIIa, IVa, and Va grades (i.e. participants must have vertex balding).
• • Use of topical minoxidil, oral minoxidil, dutasteride, finasteride, drugs with anti-androgenetic or androgenetic properties, or medications that cause hypertrichosis or hypotrichosis within the 6 months prior to enrolment.
• • Laser treatment of the scalp within 3 months prior to enrolment.
• • History of scalp micropigmentation or hair restoration surgery.
• • Use of wigs, hair extensions, hair pieces, or hair weaves at time of enrolment.
• • Use of anti-hypertensive medication.
• • Current participation in any other investigational drug or medical device trial, which includes administration of an investigational study medication or medical device, or participation in such a trial within 3 months or 5 half-lives of the investigational product, whichever is longer, prior to receiving the first dose.
• • History of hypersensitivity or allergies to minoxidil or any of the excipients contained in the study medication.
• • Known allergy or sensitivity to tattoo ink.
• • Dermatological disorder (e.g. eczema, psoriasis) or infection affecting the target area (vertex or centroparietal area).
• • Scalp characteristics, including scarring, that may interfere with examinations.
• • Medical condition which adversely affects hair loss.
• • Specific underlying conditions (e.g. cardiovascular disease, congestive cardiac failure, cardiac arrhythmia, systemic lupus erythematosus, history of phaeochromocytoma, pulmonary hypertension secondary to mitral stenosis, minoxidil hypersensitivity), clinically significant findings from medical history, clinical laboratory tests, ECG, or vital signs that, in the opinion of the Investigator, could interfere with the objectives of the study or put the participant at risk.
• • Moderate to severe renal or hepatic impairment.
• • Hypotension (blood pressure less than 90/60 mmHg) or a history of significant symptomatic postural hypotension.
• • Untreated or uncontrolled hypertension (blood pressure greater than 150/90 mmHg, not stable on current medication for the past 3 months).
• • History or evidence of hair loss other than androgenetic alopecia.
• • Unwilling to comply with all study procedures and assessments.
• • Scalp hair length less than \~2.5 cm
• • History of alcohol and/or substance abuse, or drug-abuse disorders.
• • Major surgery within 4 weeks prior to the screening evaluation, or planned surgery prior to completion of all study procedures.
• • Site employees or immediate family members of study site employees.