A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

September 30, 2026 updated by: Biosplice Therapeutics, Inc.

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle- Controlled Study of the Safety, Tolerability, and Efficacy of 0.15% and 0.25% Concentrations of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

The purpose of this study is to characterize the safety, tolerability, and efficacy of topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with Androgenetic Alopecia (AGA).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
302

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encinitas, California, United States, 92024
      • San Diego, California, United States, 92123
    • Connecticut
      • New Haven, Connecticut, United States, 06511
    • Florida
      • Miami, Florida, United States, 33143
      • West Palm Beach, Florida, United States, 33401
    • Indiana
      • Plainfield, Indiana, United States
    • Kansas
      • Wichita, Kansas, United States, 67207
    • Michigan
      • Clinton Township, Michigan, United States, 48038
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Fridley, Minnesota, United States, 55432
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • New York, New York, United States
      • Stony Brook, New York, United States, 11790
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Oregon
      • Portland, Oregon, United States, 97210
      • Portland, Oregon, United States, 97223
    • Texas
      • Austin, Texas, United States, 78759
      • College Station, Texas, United States, 77845
      • Dallas, Texas, United States, 75246
      • Houston, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States, 84117
    • Virginia
      • Lynchburg, Virginia, United States, 24501
      • Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Clinical diagnosis of AGA
  • Willing to inform females, with whom they may interact, that they are using a topical investigational product and direct contact should be avoided as potential harm to a fetus is unknown
  • Willing to maintain the same hair style as at study start for the duration of the study
  • Willing to not use semi-permanent hair products (e.g., color, texturizers, relaxers) for the duration of the study. Daily styling products will be allowed (e.g., hair gel, mousse, styling spray).
  • Willing to use a mild non-medicated shampoo and conditioner for the duration of the study
  • Willing to receive a small scalp tattoo
  • Able to read and understand English

Exclusion Criteria:

  • Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
  • Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
  • Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized, that are not using an effective method of birth control and are not willing to use an effective method of birth control during the study treatment period until 90 days post last dose of study medication
  • Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and/or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
  • History of surgical correction of hair loss on the scalp
  • Previous exposure to SM04554
  • Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 24 weeks prior to study start
  • Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 12 weeks prior to study start
  • History of hair transplants
  • Current use of an occlusive wig, hair extensions, or hair weaves
  • Participation in any other investigational drug or medical device trial, which included administration of an investigational study medication or medical device, within 30 days or 5 half-lives of the investigational agent, whichever is longer, prior to study start
  • Subjects with a history of clinically significant cardiac arrhythmia as determined by the Investigator
  • Subjects with clinically significant findings from medical history, clinical laboratory tests, electrocardiogram (ECG), or vital signs that, in the opinion of the Investigator, could interfere with the objectives of the study or put the subject at risk
  • Subjects unwilling to refrain from sperm donation during the study treatment period until 90 days post last dose of study medication
  • Subjects with pregnant partners at study start
  • Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to study start
  • Use of medicated shampoo or conditioner within 30 days prior to study start

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Topical SM04554 0.15% solution

Topical SM04554 0.15% solution, applied once a day for 90 days
Drug: Topical SM04554 solution

Study medication application will be performed by the individual subject at approximately the same time each day.
Experimental: Topical SM04554 0.25% solution

Topical SM04554 0.25% solution, applied once a day for 90 days
Drug: Topical SM04554 solution

Study medication application will be performed by the individual subject at approximately the same time each day.
Placebo Comparator: Vehicle

Topical vehicle solution, applied once a day for 90 days
Drug: Topical vehicle solution

Vehicle solution application will be performed by the individual subject at approximately the same time each day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Non-vellus Hair Count
Time Frame: Day 45, Day 90, and Day 135

Change from baseline in non-vellus hair count over time.

Non-vellus hair count was determined by macrophotography. Standardized macrophotography color photographs of the treatment area were taken on Visit Day 0 (pre-treatment), as well as on Visit Days 45 and 90, and 135. A circular area of the subject's hair 1.9 cm in diameter was clipped to approximately 1 mm in length prior to performing the macrophotography. On Visit Day 0, a scalp tattoo approximately 1 mm in size and located in the center of the target area of hair was applied to anchor the macrophotography. Photos were uploaded from sites to the vendor where blinded assessment of the macrophotography took place.
Day 45, Day 90, and Day 135
Change in Subject Assessment of Hair Growth and Quality
Time Frame: Day 45, Day 90, and Day 135

Change in Men's Hair Growth Questionnaire (MHGQ) over time as compared to Baseline. The MHGQ is a subject-completed assessment that asks the subject to evaluate his hair growth and quality since the start of the study.
Day 45, Day 90, and Day 135

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Hair Growth as Assessed by the Investigator
Time Frame: Day 45, Day 90, and Day 135

Change in hair growth over time as compared to Baseline, as assessed by the investigator, using a 7-point scale from -3 (greatly decreased) to +3 (greatly increased). Responses were analyzed using logistic regression modeling improvement vs no change/worsening of hair status at each visit.
Day 45, Day 90, and Day 135
Impact of AGA on Quality of Life
Time Frame: Day 45, Day 90, and Day 135

Change from baseline in subject responses to the Kingsley Alopecia Profile (KAP) questionnaire over time.

The KAP is a validated, patient-reported outcome that quantitatively measure the impact androgenetic alopecia on the subject's quality of life. Each of the 38 KAP 5-category Likert-scaled questions was scored +2 'Strongly Agree' to -2 'Strongly Disagree.' The KAP score was summed across all 38 questions for a score ranging from +76 to -76, with higher scores indicating an increasing negative impact on quality of life. Change from baseline was calculated as visit - baseline such that negative values reflecting improving quality of life.
Day 45, Day 90, and Day 135
Change From Baseline in Total Sum of Hair Width
Time Frame: Day 45, Day 90, and Day 135

Non-vellus hair width was determined by macrophotography. Standardized macrophotography color photographs of the treatment area were taken on Visit Day 0 (pre-treatment), as well as on Visit Days 45 and 90, and 135. A circular area of the subject's hair 1.9 cm in diameter was clipped to approximately 1 mm in length prior to performing the macrophotography. On Visit Day 0, a scalp tattoo approximately 1 mm in size and located in the center of the target area of hair was applied to anchor the macrophotography. Photos were uploaded from sites to the vendor where blinded assessment of the macrophotography took place.

While the protocol and SAP listed this outcome as hair density, the actual outcome analyzed was the total sum of non-vellus hair width in microns within the target area provided by macrophotography.
Day 45, Day 90, and Day 135

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosplice Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yusuf Yazici, M.D., Biosplice Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SM04554-AGA-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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