AlopeciaPhase 1NCT01189279
Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
A Phase 1 study testing bimatoprost Formulation A, bimatoprost Formulation B and bimatoprost Formulation C in people with Alopecia and Alopecia, Androgenetic, run by Allergan at 1 site in United States.
Trial summary
This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Alopecia, Alopecia, Androgenetic, Baldness
- What is being tested?
- bimatoprost Formulation A, bimatoprost Formulation B and bimatoprost Formulation C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Feb 2011
- Phase
- Phase 1
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males with moderate male-pattern baldness (androgenic alopecia)
- Females with moderate female pattern hair loss
- Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products
Who cannot join
- Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females)
- Use of bimatoprost or other prostaglandin analogs within 3 months
- Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months
- Any prior hair growth procedures (eg, hair transplant or laser)
- Blood donation or equivalent blood loss within 90 days
- History of alcohol or drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.
- Conditions
- Alopecia, Alopecia, Androgenetic, Baldness
- Being tested
- bimatoprost Formulation A, bimatoprost Formulation B, bimatoprost Formulation C
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost Formulation ADrug
bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
bimatoprost Formulation BDrug
bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
bimatoprost Formulation CDrug
bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: bimatoprost Formulation A | Experimental | bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. Receives: Drug: bimatoprost Formulation A |
| Part 1: bimatoprost Formulation B | Experimental | bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. Receives: Drug: bimatoprost Formulation B |
| Part 2: bimatoprost Formulation C | Experimental | bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. Receives: Drug: bimatoprost Formulation C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost
Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
Measured: Day 1
Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost
Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
Measured: 17 Days
Secondary outcomes (3)
Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings
An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T [measured in milliseconds (ms)], as well as the heart rate [measured in beats per minute (bpm)]. Clinically significant abnormal results include maximum post-treatment QTcB>500 ms, maximum post-treatment QTcF>500 ms, maximum post-treatment QT interval >500 ms, PR interval 25% increase from baseline and >200 ms, QRS interval 25% increase from baseline and >100 ms, heart rate 25% increase from baseline and >100 bpm, and heart rate 25% decrease from baseline and <50 bpm.
Measured: 17 Days
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment
Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms.
Measured: Baseline, 20 Days
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment
Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms.
Measured: Baseline, 20 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2011
- Study completionFeb 2011
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 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
- NCT01189279
- Sponsor's protocol ID
- 192024-053
- Status last verified
- Jun 2013
- First submitted
- 25 Aug 2010
- Last updated
- 30 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
- ClinicalTrials.gov ID
- NCT01189279
- Acronym / sponsor ID
- 192024-053
- Conditions
- Alopecia, Alopecia, Androgenetic, Baldness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Posted 30 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: bimatoprost Formulation A | Experimental | Drug: bimatoprost Formulation Abimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. |
| Part 1: bimatoprost Formulation B | Experimental | Drug: bimatoprost Formulation Bbimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. |
| Part 2: bimatoprost Formulation C | Experimental | Drug: bimatoprost Formulation Cbimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males with moderate male-pattern baldness (androgenic alopecia)
- Females with moderate female pattern hair loss
- Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products
Key exclusion criteria (6 listed)
- Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females)
- Use of bimatoprost or other prostaglandin analogs within 3 months
- Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months
- Any prior hair growth procedures (eg, hair transplant or laser)
- Blood donation or equivalent blood loss within 90 days
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 |
|---|---|---|
| bimatoprost Formulation Abimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. | Drug | Part 1: bimatoprost Formulation A |
| bimatoprost Formulation Bbimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. | Drug | Part 1: bimatoprost Formulation B |
| bimatoprost Formulation Cbimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. | Drug | Part 2: bimatoprost Formulation C |
Primary outcome
Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost
Time frame: Day 1
Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost
Time frame: 17 Days
Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
3 secondary outcomes
Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings
Time frame: 17 Days
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment
Time frame: Baseline, 20 Days
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment
Time frame: Baseline, 20 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Alopecia
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
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
1 site 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 Formulation A, bimatoprost Formulation B and bimatoprost Formulation C in people with Alopecia and Alopecia, Androgenetic, run by Allergan 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 3 inclusion and 6 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 30 Aug 2013. 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. 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?
Yes. Results are posted in the registry (first posted 30 Aug 2013). 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?
Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost (time frame: Day 1). 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?
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 30 Aug 2013.