AlopeciaPhase 1NCT02676310
Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)
A Phase 1 study testing Bimatoprost in people with Alopecia and Alopecia, Androgenetic, run by Allergan at 3 sites in United States.
Trial summary
This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA). Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- Alopecia, Alopecia, Androgenetic, Baldness
- What is being tested?
- Bimatoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2016to Mar 2017
- Phase
- Phase 1
- 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 18 to 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
Who cannot join
- History of Paget's disease, osteoporosis, or bone malignancy
- History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures
- Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study
- Drug or alcohol abuse within 12 months
- HIV positive
- Received hair transplants or had scalp reductions
- Use of hair weaves, hair extensions or wigs within 3 months
- Application of topical medications, minoxidil or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DermResearch, LLC
Austin, Texas, 78759
J&S Studies Inc.
College Station, Texas, 77845
E&R Research Foundation
Lynchburg, Virginia, 24501
About this study
Official title: Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men
This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).
- Conditions
- Alopecia, Alopecia, Androgenetic, Baldness
- Being tested
- Bimatoprost
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimatoprostDrug
Also called Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Bimatoprost 0.3% (Formulation B) | Experimental | 0.25 mL of bimatoprost 0.3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. Receives: Drug: Bimatoprost |
| Cohort 2: Bimatoprost 1% (Formulation A) | Experimental | 0.25 mL of bimatoprost 1% (Formulation A) applied onto pre-specified area on the scalp once daily for 28 days. Receives: Drug: Bimatoprost |
| Cohort 2: Bimatoprost 1% (Formulation B) | Experimental | 0.25 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. Receives: Drug: Bimatoprost |
| Cohort 3: Bimatoprost 1% (Formulation B) | Experimental | 1 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. Receives: Drug: Bimatoprost |
| Cohort 4: Bimatoprost 3% (Formulation B) | Experimental | 1 mL of bimatoprost 3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. Receives: Drug: Bimatoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: 42 Days
Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
Measured: Baseline, 42 Days
Maximum plasma level (Cmax) of bimatoprost and its acid metabolite
Measured: 31 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676310
- Sponsor's protocol ID
- 192024-085
- Status last verified
- Mar 2017
- First submitted
- 4 Feb 2016
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men
- ClinicalTrials.gov ID
- NCT02676310
- Acronym / sponsor ID
- 192024-085
- Conditions
- Alopecia, Alopecia, Androgenetic, Baldness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 53 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Feb 2016 (estimated)
- 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.
This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Bimatoprost 0.3% (Formulation B) | Experimental | Drug: Bimatoprost0.25 mL of bimatoprost 0.3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. |
| Cohort 2: Bimatoprost 1% (Formulation A) | Experimental | Drug: Bimatoprost0.25 mL of bimatoprost 1% (Formulation A) applied onto pre-specified area on the scalp once daily for 28 days. |
| Cohort 2: Bimatoprost 1% (Formulation B) | Experimental | Drug: Bimatoprost0.25 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. |
| Cohort 3: Bimatoprost 1% (Formulation B) | Experimental | Drug: Bimatoprost1 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. |
| Cohort 4: Bimatoprost 3% (Formulation B) | Experimental | Drug: Bimatoprost1 mL of bimatoprost 3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
Key exclusion criteria (8 listed)
- History of Paget's disease, osteoporosis, or bone malignancy
- History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures
- Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study
- Drug or alcohol abuse within 12 months
- HIV positive
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 |
|---|---|---|
| BimatoprostAlso: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days. | Drug | Cohort 1: Bimatoprost 0.3% (Formulation B), Cohort 2: Bimatoprost 1% (Formulation A), Cohort 2: Bimatoprost 1% (Formulation B), Cohort 3: Bimatoprost 1% (Formulation B), Cohort 4: Bimatoprost 3% (Formulation B) |
Primary outcome
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: 42 Days
Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
Time frame: Baseline, 42 Days
Maximum plasma level (Cmax) of bimatoprost and its acid metabolite
Time frame: 31 Days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
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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.
Medical Director study director
Allergan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bimatoprost in people with Alopecia and Alopecia, Androgenetic, run by Allergan at 3 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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early. Results are not available in the source record.
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?
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) (time frame: 42 Days). The study lists 3 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 17 Mar 2017.