Androgenetic AlopeciaPhase 2NCT02275351

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

A Phase 2 study testing Topical SM04554 solution in people with Androgenetic Alopecia, run by Biosplice Therapeutics, Inc. at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 to 55 years, men only
Conditions the study is for: Androgenetic Alopecia
What is being tested?: Topical SM04554 solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 302 participants
Where: 24 sitesUnited States
Study dates: Nov 2014to Nov 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

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

Other trials in United States

About this study

Official title: 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)

Conditions: Androgenetic Alopecia
Being tested: Topical SM04554 solution, Topical vehicle solution
Keywords: alopecia, topical, Samumed
Medical subject headings: Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Topical SM04554 solutionDrug
Study medication application will be performed by the individual subject at approximately the same time each day.
Topical SM04554 solutionDrug
Study medication application will be performed by the individual subject at approximately the same time each day.
Topical vehicle solutionDrug
Vehicle solution application will be performed by the individual subject at approximately the same time each day.

Study groups in NCT02275351
Study group	Role	What they receive
Topical SM04554 0.15% solution	Experimental	Topical SM04554 0.15% solution, applied once a day for 90 days Receives: Drug: Topical SM04554 solution
Topical SM04554 0.25% solution	Experimental	Topical SM04554 0.25% solution, applied once a day for 90 days Receives: Drug: Topical SM04554 solution
Vehicle	Placebo comparator	Topical vehicle solution, applied once a day for 90 days Receives: Drug: Topical vehicle solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Non-vellus Hair Count
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.
Measured: Day 45, Day 90, and Day 135
Change in Subject Assessment of Hair Growth and Quality
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.
Measured: Day 45, Day 90, and Day 135

Secondary outcomes (3)

Change in Hair Growth as Assessed by the Investigator
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.
Measured: Day 45, Day 90, and Day 135
Impact of AGA on Quality of Life
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.
Measured: Day 45, Day 90, and Day 135
Change From Baseline in Total Sum of Hair Width
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.
Measured: Day 45, Day 90, and Day 135

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Nov 2015

First posted27 Oct 2014 (estimated)
Study startNov 2014
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02275351
Sponsor's protocol ID: SM04554-AGA-02
Status last verified: Sep 2026
First submitted: 23 Oct 2014
Last updated: 21 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

All Androgenetic Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02275351
Acronym / sponsor ID: SM04554-AGA-02
Conditions: Androgenetic Alopecia
Keywords: alopecia, topical, Samumed
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2014 (actual)
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 27 Oct 2014 (estimated)
Results: Posted 1 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Topical SM04554 0.15% solution	Experimental	Drug: Topical SM04554 solutionTopical SM04554 0.15% solution, applied once a day for 90 days
Topical SM04554 0.25% solution	Experimental	Drug: Topical SM04554 solutionTopical SM04554 0.25% solution, applied once a day for 90 days
Vehicle	Placebo comparator	Drug: Topical vehicle solutionTopical vehicle solution, applied once a day for 90 days

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Topical SM04554 solutionStudy medication application will be performed by the individual subject at approximately the same time each day.	Drug	Topical SM04554 0.15% solution
Topical SM04554 solutionStudy medication application will be performed by the individual subject at approximately the same time each day.	Drug	Topical SM04554 0.25% solution
Topical vehicle solutionVehicle solution application will be performed by the individual subject at approximately the same time each day.	Drug	Vehicle

Primary outcome

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.
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.

3 secondary outcomes

Change in Hair Growth as Assessed by the Investigator
Time frame: 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 Total Sum of Hair Width
Time frame: Day 45, Day 90, and Day 135

Results and safety

Results posted to the registry on 1 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SM04554 0.15%	102	74
SM04554 0.25%	102	77
Vehicle	98	76

Primary outcome: Change From Baseline in Non-vellus Hair Count

Time frame: Day 45, Day 90, and Day 135. Mean (Standard Deviation). Unit: Non-vellus hair count

Measure	SM04554 0.15% n = 102	SM04554 0.25% n = 102	Vehicle n = 98
Day 45	4.6 (16.97)	2.6 (14.35)	5.7 (13.27)
Day 90 (Primary efficacy, treatment completion, time point)	4.2 (17.88)	3.2 (15.66)	6.2 (14.75)
Day 135	7.9 (17.95)	3.3 (15.78)	4.2 (18.77)

SM04554 0.15% vs Vehicle: Least squares estimate of difference: -0.9, p = 0.6869, ANCOVA
SM04554 0.25% vs Vehicle: Least squares estimate of difference: -3.1, p = 0.1658, ANCOVA
SM04554 0.15% vs Vehicle: Least squares estimate of difference: -2.1, p = 0.4297, ANCOVA

Population analysed: The overall number of participants analyzed includes all subjects who received at least one dose of study treatment.

Primary outcome: Change in Subject Assessment of Hair Growth and Quality

Time frame: Day 45, Day 90, and Day 135. Count of participants. Unit: Participants

Measure	SM04554 0.15% n = 102	SM04554 0.25% n = 102	Vehicle n = 98
1. Bald spot getting smaller - Day 45: Worsening	55	39	38
1. Bald spot getting smaller - Day 45: No Change	24	37	32
1. Bald spot getting smaller - Day 45: Improvement	13	21	20
1. Bald spot getting smaller - Day 90: Worsening	51	44	40
1. Bald spot getting smaller - Day 90: No Change	14	20	23
1. Bald spot getting smaller - Day 90: Improvement	13	18	17
1. Bald spot getting smaller - Day 135: Worsening	51	47	44
1. Bald spot getting smaller - Day 135: No Change	11	18	19

SM04554 0.15% vs Vehicle: Odds Ratio (OR): 0.54 (95% CI 0.248 to 1.185), p = 0.1248, Regression, Logistic
SM04554 0.15% vs Vehicle: Odds Ratio (OR): 0.66 (95% CI 0.290 to 1.490), p = 0.3155, Regression, Logistic
SM04554 0.15% vs Vehicle: Odds Ratio (OR): 1.26 (95% CI 0.533 to 2.966), p = 0.6002, Regression, Logistic

Population analysed: The overall number of participants analyzed includes all subjects who received at least one dose of study treatment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were assessed at each study visit from the start of study medication application on Day 1 through Day 135 (End of Study) which was 45 days after last application of study medication.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SM04554 0.15%	0 of 102 (0%)	45 of 102 (44.1%)	0 of 102
SM04554 0.25%	0 of 102 (0%)	46 of 102 (45.1%)	0 of 102
Vehicle	1 of 98 (1%)	47 of 98 (48%)	0 of 98

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Androgenetic Alopecia

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
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Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
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Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yusuf Yazici, M.D. study director

Biosplice Therapeutics, Inc.

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topical SM04554 solution in people with Androgenetic Alopecia, run by Biosplice Therapeutics, Inc. at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Non-vellus Hair Count (time frame: Day 45, Day 90, and Day 135). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02275351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.