Androgenetic AlopeciaPhase 2NCT02503137

A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing

A Phase 2 study testing Topical SM04554 solution in people with Androgenetic Alopecia, run by Biosplice Therapeutics, Inc. at 5 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of 0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554 and compared to placebo may lead to a… Read more about this study

Who is it for?: Ages 18 to 65 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: 49 participants
Where: 5 sitesUnited States
Study dates: Aug 2015to Apr 2016
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 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 4, 5, 5A, 5V, or 6
In good general health, as determined by the Investigator
Willing and able to attend all study visits
Willing to undergo two punch biopsies of the scalp
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 not use permanent or semi-permanent hair products (e.g., color, texturizers, relaxers) for the duration of the study; daily styling products will be allowed on non-study visit days (e.g., hair gel, mousse, styling spray)
Willing to use sponsor-supplied shampoo and conditioner in place of regular shampoo and conditioner, for the duration of the study; use of sponsor-supplied conditioner is optional for subjects who do not use conditioner

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 a highly effective method of birth control and are not willing to use a highly 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, eczema, sun damage, seborrheic dermatitis, actinic keratosis), cuts and/or abrasions on the scalp or hands or condition (e.g., sunburn, tattoos) on the treatment area or hands that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
History of or current skin cancer (e.g., melanoma, basal cell carcinoma, squamous cell carcinoma) located anywhere on the body
History of surgical correction of hair loss on the scalp

Show all 20Show fewer

Previous exposure to SM04554
Use of blood thinners (e.g., Coumadin, Plavix, Lovenox, and aspirin >81mg); low dose aspirin (e.g., ≤81 mg) is allowable
Use of any products or devices clinically proven to promote scalp hair growth (e.g., finasteride or minoxidil) within 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
Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to study start
Use of medicated shampoo or conditioner (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the-counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth) within 30 days 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
Poor peripheral venous access
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
Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Research Site
Cleveland, Ohio
Research Site
Clinton Township, Michigan
Research Site
College Station, Texas
Research Site
Houston, Texas
Research Site
Lynchburg, Virginia

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia (AGA) Analyzed by Biopsy of the Scalp Prior To and Post Dosing

Conditions: Androgenetic Alopecia
Being tested: Topical SM04554 solution, Topical vehicle solution
Keywords: male pattern baldness, SM04554, AGA
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 NCT02503137
Study group	Role	What they receive
Topical SM04554 0.15% solution	Experimental	Topical SM04554 0.15% solution, once daily for approximately 90 days Receives: Drug: Topical SM04554 solution
Topical SM04554 0.25% solution	Experimental	Topical SM04554 0.25% solution, once daily for approximately 90 days Receives: Drug: Topical SM04554 solution
Vehicle	Placebo comparator	Topical vehicle solution, once daily for approximately 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/Day 91 in Number of Terminal Hair Follicles (Terminal Anagen + Terminal Catagen and Telogen Follicles)
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135
Change From Baseline/Day 91 in Number of Terminal Anagen Hair Follicles
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135
Change From Baseline/Day 91 in Number of Terminal Catagen and Telogen Hair Follicles
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135
Change From Baseline/Day 91 in Number of Miniaturized Hair Follicles (Indeterminate + Vellus Follicles)
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135
Change From Baseline/Day 91 in Number of Indeterminate Hair Follicles
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135
Change From Baseline/Day 91 in Number of Vellus Hair Follicles
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135

Secondary outcomes (5)

Terminal and Miniaturized Hair Follicle Density/mm²
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135
Ratio of Terminal to Miniaturized Hair Follicles
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135
Beta-catenin in Epidermis and Infundibulum
Immunohistochemistry of scalp biopsies were used to analyze the nuclear expression outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Percentage of positively-stained nuclei were reported at each timepoint. Change from baseline in percentage of positively-stained nuclei is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135
Ki-67 in Epidermis and Infundibulum
Immunohistochemistry of scalp biopsies were used to analyze the nuclear expression outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Percentage of positively-stained nuclei were reported at each timepoint. Change from baseline in percentage of positively-stained nuclei is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135
Ki-67 in Hair Bulb
Immunohistochemistry of scalp biopsies were used to analyze the nuclear expression outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Percentage of positively-stained nuclei were reported at each timepoint. Change from baseline in percentage of positively-stained nuclei is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Measured: Day 91 and Day 135

Timeline

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

Aug 2015Apr 2016

First posted20 Jul 2015 (estimated)
Study startAug 2015
Primary completionApr 2016
Study completionApr 2016

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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02503137
Sponsor's protocol ID: SM04554-AGA-04
Status last verified: Sep 2026
First submitted: 16 Jul 2015
Last updated: 1 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Double-Blind Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia (AGA) Analyzed by Biopsy of the Scalp Prior To and Post Dosing
ClinicalTrials.gov ID: NCT02503137
Acronym / sponsor ID: SM04554-AGA-04
Conditions: Androgenetic Alopecia
Keywords: male pattern baldness, SM04554, AGA
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2015
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 20 Jul 2015 (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: Triple blind (participant, care provider, investigator)
Number of arms: 3

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

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 4, 5, 5A, 5V, or 6
In good general health, as determined by the Investigator
Willing and able to attend all study visits
Willing to undergo two punch biopsies of the scalp
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

Key exclusion criteria (20 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 a highly effective method of birth control and are not willing to use a highly 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, eczema, sun damage, seborrheic dermatitis, actinic keratosis), cuts and/or abrasions on the scalp or hands or condition (e.g., sunburn, tattoos) on the treatment area or hands that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
History of or current skin cancer (e.g., melanoma, basal cell carcinoma, squamous cell carcinoma) located anywhere on the body

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/Day 91 in Number of Terminal Hair Follicles (Terminal Anagen + Terminal Catagen and Telogen Follicles)
Time frame: Day 91 and Day 135
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Change From Baseline/Day 91 in Number of Terminal Anagen Hair Follicles
Time frame: Day 91 and Day 135
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Change From Baseline/Day 91 in Number of Terminal Catagen and Telogen Hair Follicles
Time frame: Day 91 and Day 135
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Change From Baseline/Day 91 in Number of Miniaturized Hair Follicles (Indeterminate + Vellus Follicles)
Time frame: Day 91 and Day 135
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Change From Baseline/Day 91 in Number of Indeterminate Hair Follicles
Time frame: Day 91 and Day 135
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.
Change From Baseline/Day 91 in Number of Vellus Hair Follicles
Time frame: Day 91 and Day 135
Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

5 secondary outcomes

Terminal and Miniaturized Hair Follicle Density/mm²
Time frame: Day 91 and Day 135
Ratio of Terminal to Miniaturized Hair Follicles
Time frame: Day 91 and Day 135
Beta-catenin in Epidermis and Infundibulum
Time frame: Day 91 and Day 135
Ki-67 in Epidermis and Infundibulum
Time frame: Day 91 and Day 135
Ki-67 in Hair Bulb
Time frame: Day 91 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%	16	12
SM04554 0.25%	14	11
Vehicle	19	17

Primary outcome: Change From Baseline/Day 91 in Number of Terminal Hair Follicles (Terminal Anagen + Terminal Catagen and Telogen Follicles)

Time frame: Day 91 and Day 135. Mean (Standard Deviation). Unit: Hair Count

Measure	SM04554 0.15% n = 16	SM04554 0.25% n = 14	Vehicle n = 19
Day 91 (Primary) - Change from Baseline	-1.6 (3.8)	-0.3 (7.2)	-1.7 (4.1)
Day 135 - Change from Baseline	-2.1 (8.0)	-2.7 (6.0)	-3.5 (3.9)
Day 135 - Change from Day 91	-1.4 (5.0)	-0.1 (4.3)	-1.9 (4.1)

SM04554 0.15% vs Vehicle: Mean Difference (Final Values): -0.05, p = 0.9740, ANCOVA
SM04554 0.15% vs Vehicle: Mean Difference (Final Values): 2.75, p = 0.1277, ANCOVA
SM04554 0.15% vs Vehicle: Mean Difference (Final Values): 2.06, p = 0.2379, ANCOVA

Population analysed: The Intent-to-Treat includes all subjects who were randomized and describes the analysis set which is as complete and as close as possible to the intent-to-treat ideal of including all randomized subjects. Subjects' observed data were analyzed as randomized for the ITT without imputation. Of note, the Day 135 biopsy was amended to the protocol was optional.

Primary outcome: Change From Baseline/Day 91 in Number of Terminal Anagen Hair Follicles

Time frame: Day 91 and Day 135. Mean (Standard Deviation). Unit: Hair Count

Measure	SM04554 0.15% n = 16	SM04554 0.25% n = 14	Vehicle n = 19
Day 91 (Primary) - Change from Baseline	-1.1 (3.3)	1.3 (5.4)	-1.1 (3.7)
Day 135 - Change from Baseline	-2.4 (4.1)	-0.9 (2.7)	-1.9 (3.5)
Day 135 - Change from Day 91	-1.5 (2.3)	-0.6 (3.7)	-0.9 (3.1)

SM04554 0.15% vs Vehicle: Mean Difference (Final Values): 0.07, p = 0.9560, ANCOVA
SM04554 0.15% vs Vehicle: Mean Difference (Final Values): 0.78, p = 0.4476, ANCOVA
SM04554 0.15% vs Vehicle: Mean Difference (Final Values): 0.59, p = 0.6285, ANCOVA

Primary outcome: Change From Baseline/Day 91 in Number of Terminal Catagen and Telogen Hair Follicles

Time frame: Day 91 and Day 135. Mean (Standard Deviation). Unit: Hair Count

Measure	SM04554 0.15% n = 16	SM04554 0.25% n = 14	Vehicle n = 19
Day 91 (Primary) - Change from Baseline	-0.5 (2.8)	-1.6 (3.4)	-0.6 (2.3)
Day 135 - Change from Baseline	0.3 (5.7)	-1.9 (4.6)	-1.6 (1.9)
Day 135 - Change from Day 91	0.1 (5.2)	0.4 (1.6)	-1.0 (2.0)

SM04554 0.15% vs Vehicle: Mean Difference (Final Values): -0.26, p = 0.7323, ANCOVA
SM04554 0.15% vs Vehicle: Mean Difference (Final Values): 1.45, p = 0.1689, ANCOVA
SM04554 0.15% vs Vehicle: Mean Difference (Final Values): 1.53, p = 0.1711, ANCOVA

Primary outcome: Change From Baseline/Day 91 in Number of Miniaturized Hair Follicles (Indeterminate + Vellus Follicles)

Time frame: Day 91 and Day 135. Mean (Standard Deviation). Unit: Hair Count

Measure	SM04554 0.15% n = 16	SM04554 0.25% n = 14	Vehicle n = 19
Day 91 (Primary) - Change from Baseline	-1.8 (18.3)	0.3 (19.0)	-5.0 (11.5)
Day 135 - Change from Baseline	4.1 (13.1)	1.4 (5.3)	-2.8 (7.7)
Day 135 - Change from Day 91	8.0 (18.7)	-3.9 (19.2)	4.4 (14.0)

SM04554 0.15% vs Vehicle: Mean Difference (Final Values): 2.95, p = 0.5815, ANCOVA
SM04554 0.15% vs Vehicle: Mean Difference (Final Values): 7.92, p = 0.0665, ANCOVA
SM04554 0.15% vs Vehicle: Mean Difference (Final Values): 8.91, p = 0.1663, ANCOVA

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent AEs reporting start with the subject's first exposure to study medication at Day 1 through Day 135 (End of Study) or early termination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SM04554 0.15%	0 of 16 (0%)	9 of 16 (56.3%)	0 of 16
SM04554 0.25%	0 of 14 (0%)	9 of 14 (64.3%)	0 of 14
Vehicle	0 of 19 (0%)	11 of 19 (57.9%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
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

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.

5 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 5 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 20 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 1 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 5 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/Day 91 in Number of Terminal Hair Follicles (Terminal Anagen + Terminal Catagen and Telogen Follicles) (time frame: Day 91 and Day 135). The study lists 6 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 NCT02503137.

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 1 Oct 2026.