Male Pattern Hair LossPhase 2NCT03852992
Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia
A Phase 2 study testing Post-Laser Minoxidil 2%, At-Home Minoxidil 5% and Laser in people with Male Pattern Hair Loss and Androgenetic Alopecia, run by University of Minnesota at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of fractionated ablative 10,600nm CO2 laser assisted delivery of 2% minoxidil solution in the treatment of MPHL. Read more about this study
- Who is it for?
- Ages 21 to 65 years, men only
- Conditions the study is for
- Male Pattern Hair Loss, Androgenetic Alopecia, Male Pattern Baldness
- What is being tested?
- Post-Laser Minoxidil 2%, At-Home Minoxidil 5% and Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 1 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 21 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males ages 21-65 years old with MPHL
- Norwood III vertex-V. The vertex scalp must be involved
- MPHL diagnosed by a board-certified dermatologist
- Willing to abstain from use of over the counter products and prescription products other than those supplied in the study
- Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation
- Subjects must be capable of giving informed consent
- Willing to adhere to protocol, including scalp examinations and photography
Who cannot join
- Allergy or intolerance to minoxidil
- Underlying disease that might be adversely affected by minoxidil.
- Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV)
- Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks
- Systemic administration of corticosteroid or other systemic treatment (e.g. prednisone) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks or planned usage at any time throughout the study
- Clinical evidence of secondary skin infection (e.g. folliculitis)
Show all 33Show fewer
- Other inflammatory or infectious skin disease that might interfere with evaluations during the study
- Investigational medications within the past 30 days
- Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies
- Oral retinoids within the past 6 months and topical retinoid usage within the past 4 weeks
- Patients with history of or susceptible to keloid formation
- Finasteride or dutasteride within the past 6 weeks
- Spironolactone within the past 6 weeks
- Active infection
- Lesions in the treated area suspicious for malignancy
- Known allergy to hair dye or hair dye components
- Relevant history of hypotension
- Hypertension that is untreated or uncontrolled
- Radiation or chemotherapy to the site
- Use of topical or oral ketoconazole in the past 6 weeks
- Hair transplants or weaves
- Other concomitant types of history of hair loss such as telogen effluvium
- Medical problems including HIV, connective tissue disorder, PCOS, untreated thyroid disease
- Psychiatric disease that that may increase risks within the trial
- Current use of tanning beds or any active tanning
- Use of antihypertensives or vasodilators following a first-time diagnosis of hypertension within the past 6 months
- Planned upcoming surgeries
- Tattoo on scalp
- Use of oral minoxidil within the past 6 months
- History of orthostatic hypotension
- Adults lacking capacity to consent
- Adults who do not speak English.
- A medical history or clinical evidence of: acute myocardial infarction, angina, cardiac disease, cardiac tamponade, cerebrovascular disease, coronary artery disease, hypotension, orthostatic hypotension, pericardial effusion, peripheral edema, heart failure, pulmonary hypertension, renal disease, renal failure, renal impairment, pregnancy, breast-feeding, children, pheochromocytoma, skin abrasion, and geriatric.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: The Safety and Efficacy of Fractional Ablative 10, 600nm CO2 Laser-assisted Treatments for Male Pattern Hair Loss: a Randomized Cohort Study Comparing Stand-alone Laser Treatment, Laser Assisted Drug Delivery of Minoxidil 2% Solution , and Laser Assisted Drug Delivery of Minoxidil 2% Solution Plus Self-administration of Minoxidil 5% at Home.
The objective of this study is to evaluate the safety and efficacy of fractionated ablative 10,600nm CO2 laser assisted delivery of 2% minoxidil solution in the treatment of MPHL. In this cohort study, patients will randomly be assigned stand-alone laser treatment, laser assisted drug delivery of minoxidil 2% solution, and laser assisted drug delivery of minoxidil 2% solution plus at home 5% minoxidil treatment. The primary endpoints will be to assess the change from baseline in investigator and subject Hair Growth Assessments (HGA), Hair Growth Index (HGI) and the Hair Growth Satisfaction Scale (HGSS) over 8-12 weeks in each of the three groups. The secondary endpoints will be expert assessment of hair density from baseline and evaluation of safety and adverse events, and pharmacokinetic (PK) data.
Read the detailed description
Male pattern hair loss (MPHL) is a common, frustrating, and difficult to manage scalp disease with few treatment options available. Though the mechanism remains unclear, minoxidil is a well-established treatment for MPHL. With the advent of laser assisted drug delivery, the investigators seek to investigate the use of laser assisted minoxidil delivery to improve bioavailability, and subsequent hair growth for subjects MPHL. With an improved clinical outcome and increased treatment efficiency, patient quality of life would be enhanced and fewer at home topical treatments with minoxidil may be required. Additionally, this study will assist in understanding the effects of stand-alone laser therapy on hair growth and may also be used as a background or framework for a growing number of studies investigating this technology as a drug delivery system.
MPHL, also known as androgenetic alopecia, is a non-scarring alopecia resulting in gradual hair loss localized to the scalp. In men, this progressive hair loss disorder results in characteristic thinning of hair over the vertex and frontal regions.1 The Hamilton-Norwood scale categorizes this typical clinical progression.2 While the pathogenesis of MPHL is not entirely elucidated, it has been proposed to be an age and hormone dependent process with dihydrotestosterone playing a significant role.2,3 Genetic factors may also contribute to the disease.4
Topical minoxidil is an FDA approved treatment for MPHL. Minoxidil 2 and 5% solution are known to increase hair regrowth in men with androgenetic alopecia.7 While the mechanism remains unknown, it has been proposed minoxidil increases the duration of anagen and vascular supply to the follicular structure.8
Topical treatments for MPHL such as minoxidil have limited efficacy, as topical delivery of medication has low bioavailability.9 With the advent of fractionated ablative and non-ablative laser technologies, more efficient drug delivery to the level of the superficial epidermis and dermis is now possible.
The outermost layer of skin, the stratum corneum, impedes the diffusion of topical medications to follicular structures in the dermis and hypodermis. 9 Ablative fractionated laser devices create vertical channels, permitting topical medication to breach the skin's top layer, the stratum corneum, and reach deep skin layers where hair follicles reside.9
Both ablative and non-ablative fractionated laser treatments augment collagen deposition and cause growth factor mediated changes to skin ultrastructure.10 Non-ablative fractionated laser therapy in MPHL patients improves hair density with and without topical administration of growth factor.10 Our proposed study confers an additional mode of treatment beyond laser-only therapy by using an ablative fractionated laser to deliver minoxidil 2% solution percutaneously.
Herein, the investigators seek to further optimize patient treatment by investigating a combination of these treatment modalities for management of MPHL. The investigators hypothesize that fractionated ablative 10,600nm CO2 laser treatment and laser assisted drug delivery of minoxidil 2% solution will result in increased hair growth. With this improved clinical outcome and increased treatment efficiency, patient quality of life will be enhanced and fewer at home topical treatments may be required.
- Being tested
- Post-Laser Minoxidil 2%, At-Home Minoxidil 5%, Laser, Post-laser 5mg minoxidil, Post-laser 10mg minoxidil
- Keywords
- Male Pattern Hair Loss, Androgenetic Alopecia, Male Baldness, Bald, Baldness
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-Laser Minoxidil 2%Drug
Also called Rogaine
2ml of 20mg/ml sterile solution, applied post-laser procedure
At-Home Minoxidil 5%Drug
Also called Rogaine
2ml of 50mg/ml foam q24 h for duration of study
LaserDevice
Fractional ablative, deep mode, 5% fractional coverage
Post-laser 5mg minoxidilDrug
Also called Rogaine
0.25ml of 20mg/ml sterile solution, applied post-laser procedure
Post-laser 10mg minoxidilDrug
Also called Rogaine
0.5ml of 20mg/ml sterile solution, applied post-laser procedure
Post-laser 20mg minoxidilDrug
Also called Rogaine
1ml of 20mg/ml sterile solution, applied post-laser procedure
| Study group | Role | What they receive |
|---|---|---|
| Safety Group | Experimental | will participate in one visit, receiving laser assisted delivery of minoxidil and PK data. The safety group treatments will follow dose escalation as follows:
* Safety Participant 1: Post-laser 5mg minoxidil (0.25ml of 20mg/ml sterile solution, applied post-laser procedure)
* Safety Participant 2: Post-laser 10mg minoxidil (0.5ml of 20mg/ml sterile solution, applied post-laser procedure)
* Safety Participant 3: Post-laser 20mg minoxidil (1mL of 20mg/mL sterile solution, applied post-laser procedure) Receives: Device: Laser; Drug: Post-laser 5mg minoxidil; Drug: Post-laser 10mg minoxidil; Drug: Post-laser 20mg minoxidil |
| Placebo | Placebo comparator | Laser: Fractional ablative, deep mode, 5% fractional coverage
Post-Laser Saline 0.9%: 2ml of sterile saline solution applied post-laser procedure Receives: Device: Laser |
| Treatment A | Experimental | Laser: Fractional ablative, deep mode, 5% fractional coverage
Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure Receives: Drug: Post-Laser Minoxidil 2% |
| Treatment B | Experimental | Laser: Fractional ablative, deep mode, 5% fractional coverage
Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure
At-Home Minoxidil 5%: 2ml of 50mg/ml foam q24 h for duration of study Receives: Drug: Post-Laser Minoxidil 2%; Drug: At-Home Minoxidil 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Growth Assessment (HGA)
Scale indicating graded degree of change represented as no change, worse outcome, better outcome.
Measured: End of trial (8-16 weeks)
Hair Growth Index (HGI)
Hair growth is compared from baseline by three self-report questions on a health outcome questionnaire
Measured: End of trial (8-16 weeks)
Change in Hair Growth Satisfaction Scale (HGSS)
Hair appearance/growth is compared from baseline by five self-report questions that rank satisfaction with hair growth on a scale from -3 (very dissatisfied) to 3 (very satisfied).
Measured: Week 0, Week 4(+4), Week 8(+4)
Change in Investigator Global Assessment of Photography
Scale from -3 (significant worsening) to 3 (significant improvement) assessing hair loss/growth
Measured: Week 0, end of trial (8-16 weeks)
Secondary outcomes (2)
Change in Additional Investigator Global Assessment of Photography
Scale from -3 (significant worsening) to 3 (significant improvement) assessing hair loss/growth
Measured: Week 0, end of trial (8-16 weeks)
Change in Scalp Symptom Assessments
Measure 4 criteria, erythema, scaling, pruritis, and burning/stinging, on a scale from 0 (none) to 4 (severe)
Measured: Week 0, Week 4(+4), Week 8(+4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start30 Sep 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Why it stopped: Study was closed with IRB on 10/22/22
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Pattern Hair LossStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852992
- Sponsor's protocol ID
- DERM-2018-27024
- Status last verified
- Sep 2023
- First submitted
- 21 Feb 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Fractional Ablative 10, 600nm CO2 Laser-assisted Treatments for Male Pattern Hair Loss: a Randomized Cohort Study Comparing Stand-alone Laser Treatment, Laser Assisted Drug Delivery of Minoxidil 2% Solution , and Laser Assisted Drug Delivery of Minoxidil 2% Solution Plus Self-administration of Minoxidil 5% at Home.
- ClinicalTrials.gov ID
- NCT03852992
- Acronym / sponsor ID
- DERM-2018-27024
- Keywords
- Male Pattern Hair Loss, Androgenetic Alopecia, Male Baldness, Bald, Baldness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was closed with IRB on 10/22/22
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of fractionated ablative 10,600nm CO2 laser assisted delivery of 2% minoxidil solution in the treatment of MPHL. In this cohort study, patients will randomly be assigned stand-alone laser treatment, laser assisted drug delivery of minoxidil 2% solution, and laser assisted drug delivery of minoxidil 2% solution plus at home 5% minoxidil treatment. The primary endpoints will be to assess the change from baseline in investigator and subject Hair Growth Assessments (HGA), Hair Growth Index (HGI) and the Hair Growth Satisfaction Scale (HGSS) over 8-12 weeks in each of the three groups. The secondary endpoints will be expert assessment of hair density from baseline and evaluation of safety and adverse events, and pharmacokinetic (PK) data.
Detailed description
Male pattern hair loss (MPHL) is a common, frustrating, and difficult to manage scalp disease with few treatment options available. Though the mechanism remains unclear, minoxidil is a well-established treatment for MPHL. With the advent of laser assisted drug delivery, the investigators seek to investigate the use of laser assisted minoxidil delivery to improve bioavailability, and subsequent hair growth for subjects MPHL. With an improved clinical outcome and increased treatment efficiency, patient quality of life would be enhanced and fewer at home topical treatments with minoxidil may be required. Additionally, this study will assist in understanding the effects of stand-alone laser therapy on hair growth and may also be used as a background or framework for a growing number of studies investigating this technology as a drug delivery system.
MPHL, also known as androgenetic alopecia, is a non-scarring alopecia resulting in gradual hair loss localized to the scalp. In men, this progressive hair loss disorder results in characteristic thinning of hair over the vertex and frontal regions.1 The Hamilton-Norwood scale categorizes this typical clinical progression.2 While the pathogenesis of MPHL is not entirely elucidated, it has been proposed to be an age and hormone dependent process with dihydrotestosterone playing a significant role.2,3 Genetic factors may also contribute to the disease.4
Topical minoxidil is an FDA approved treatment for MPHL. Minoxidil 2 and 5% solution are known to increase hair regrowth in men with androgenetic alopecia.7 While the mechanism remains unknown, it has been proposed minoxidil increases the duration of anagen and vascular supply to the follicular structure.8
Topical treatments for MPHL such as minoxidil have limited efficacy, as topical delivery of medication has low bioavailability.9 With the advent of fractionated ablative and non-ablative laser technologies, more efficient drug delivery to the level of the superficial epidermis and dermis is now possible.
The outermost layer of skin, the stratum corneum, impedes the diffusion of topical medications to follicular structures in the dermis and hypodermis. 9 Ablative fractionated laser devices create vertical channels, permitting topical medication to breach the skin's top layer, the stratum corneum, and reach deep skin layers where hair follicles reside.9
Both ablative and non-ablative fractionated laser treatments augment collagen deposition and cause growth factor mediated changes to skin ultrastructure.10 Non-ablative fractionated laser therapy in MPHL patients improves hair density with and without topical administration of growth factor.10 Our proposed study confers an additional mode of treatment beyond laser-only therapy by using an ablative fractionated laser to deliver minoxidil 2% solution percutaneously.
Herein, the investigators seek to further optimize patient treatment by investigating a combination of these treatment modalities for management of MPHL. The investigators hypothesize that fractionated ablative 10,600nm CO2 laser treatment and laser assisted drug delivery of minoxidil 2% solution will result in increased hair growth. With this improved clinical outcome and increased treatment efficiency, patient quality of life will be enhanced and fewer at home topical treatments may be required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Safety Group | Experimental | Device: Laser, Drug: Post-laser 5mg minoxidil, Drug: Post-laser 10mg minoxidil, Drug: Post-laser 20mg minoxidilwill participate in one visit, receiving laser assisted delivery of minoxidil and PK data. The safety group treatments will follow dose escalation as follows: * Safety Participant 1: Post-laser 5mg minoxidil (0.25ml of 20mg/ml sterile solution, applied post-laser procedure) * Safety Participant 2: Post-laser 10mg minoxidil (0.5ml of 20mg/ml sterile solution, applied post-laser procedure) * Safety Participant 3: Post-laser 20mg minoxidil (1mL of 20mg/mL sterile solution, applied post-laser procedure) |
| Placebo | Placebo comparator | Device: LaserLaser: Fractional ablative, deep mode, 5% fractional coverage Post-Laser Saline 0.9%: 2ml of sterile saline solution applied post-laser procedure |
| Treatment A | Experimental | Drug: Post-Laser Minoxidil 2%Laser: Fractional ablative, deep mode, 5% fractional coverage Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure |
| Treatment B | Experimental | Drug: Post-Laser Minoxidil 2%, Drug: At-Home Minoxidil 5%Laser: Fractional ablative, deep mode, 5% fractional coverage Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure At-Home Minoxidil 5%: 2ml of 50mg/ml foam q24 h for duration of study |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males ages 21-65 years old with MPHL
- Norwood III vertex-V. The vertex scalp must be involved
- MPHL diagnosed by a board-certified dermatologist
- Willing to abstain from use of over the counter products and prescription products other than those supplied in the study
- Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation
Key exclusion criteria (33 listed)
- Allergy or intolerance to minoxidil
- Underlying disease that might be adversely affected by minoxidil.
- Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV)
- Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks
- Systemic administration of corticosteroid or other systemic treatment (e.g. prednisone) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks or planned usage at any time throughout the study
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 |
|---|---|---|
| Post-Laser Minoxidil 2%Also: Rogaine2ml of 20mg/ml sterile solution, applied post-laser procedure | Drug | Treatment A, Treatment B |
| At-Home Minoxidil 5%Also: Rogaine2ml of 50mg/ml foam q24 h for duration of study | Drug | Treatment B |
| LaserFractional ablative, deep mode, 5% fractional coverage | Device | Placebo, Safety Group |
| Post-laser 5mg minoxidilAlso: Rogaine0.25ml of 20mg/ml sterile solution, applied post-laser procedure | Drug | Safety Group |
| Post-laser 10mg minoxidilAlso: Rogaine0.5ml of 20mg/ml sterile solution, applied post-laser procedure | Drug | Safety Group |
| Post-laser 20mg minoxidilAlso: Rogaine1ml of 20mg/ml sterile solution, applied post-laser procedure | Drug | Safety Group |
Primary outcome
Hair Growth Assessment (HGA)
Time frame: End of trial (8-16 weeks)
Scale indicating graded degree of change represented as no change, worse outcome, better outcome.
Hair Growth Index (HGI)
Time frame: End of trial (8-16 weeks)
Hair growth is compared from baseline by three self-report questions on a health outcome questionnaire
Change in Hair Growth Satisfaction Scale (HGSS)
Time frame: Week 0, Week 4(+4), Week 8(+4)
Hair appearance/growth is compared from baseline by five self-report questions that rank satisfaction with hair growth on a scale from -3 (very dissatisfied) to 3 (very satisfied).
Change in Investigator Global Assessment of Photography
Time frame: Week 0, end of trial (8-16 weeks)
Scale from -3 (significant worsening) to 3 (significant improvement) assessing hair loss/growth
2 secondary outcomes
Change in Additional Investigator Global Assessment of Photography
Time frame: Week 0, end of trial (8-16 weeks)
Change in Scalp Symptom Assessments
Time frame: Week 0, Week 4(+4), Week 8(+4)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Post-Laser Minoxidil 2%, At-Home Minoxidil 5% and Laser in people with Male Pattern Hair Loss and Androgenetic Alopecia, run by University of Minnesota at 1 site 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 33 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: withdrawn, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Hair Growth Assessment (HGA) (time frame: End of trial (8-16 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.