Trial · NCT01189279
Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
NCT01189279, Phase 1, Completed, Allergan; results first posted 2013-08-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia. Trials, record NCT01189279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01189279
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
- NCT number
- NCT01189279
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 42 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Alopecia, Alopecia, Androgenetic, Baldness
- Interventions
- bimatoprost Formulation A, bimatoprost Formulation B, bimatoprost Formulation C
- First posted
- 2010-08-26
- Last updated
- 2013-08-30
- Results first posted
- 2013-08-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | 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. |
| Primary | Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | 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. |
| Secondary | Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | 17 Days | 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. |
| Secondary | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Baseline, 20 Days | 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. |
| Secondary | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Baseline, 20 Days | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | Day 1 | Per Protocol: all subjects with no major protocol deviations | Picograms/Milliliter (pg/mL) | MEAN |
| PRIMARY | Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | 17 Days | Per Protocol: all subjects with no major protocol deviations | Picograms/Milliliter (pg/mL) | MEAN |
| SECONDARY | Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | 17 Days | Safety Population: all subjects who received at least 1 dose of study medication | Percentage of Patients | NUMBER |
| SECONDARY | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Baseline, 20 Days | Safety Population: all subjects who received at least 1 dose of study medication | Patients | NUMBER |
| SECONDARY | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Baseline, 20 Days | Safety Population: all subjects who received at least 1 dose of study medication | Patients | NUMBER |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | Part 1: Bimatoprost Formulation A | 0.552 | Standard Deviation 0.575 | Picograms/Milliliter (pg/mL) | |
| Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | Part 1: Bimatoprost Formulation B | 1.77 | Standard Deviation 1.11 | Picograms/Milliliter (pg/mL) | |
| Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | Part 2: Bimatoprost Formulation C | 5.58 | Standard Deviation 3.66 | Picograms/Milliliter (pg/mL) | |
| Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | Part 1: Bimatoprost Formulation A | 1.26 | Standard Deviation 0.60 | Picograms/Milliliter (pg/mL) | |
| Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | Part 1: Bimatoprost Formulation B | 3.01 | Standard Deviation 1.66 | Picograms/Milliliter (pg/mL) | |
| Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | Part 2: Bimatoprost Formulation C | 10.1 | Standard Deviation 7.0 | Picograms/Milliliter (pg/mL) | |
| Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | Part 1: Bimatoprost Formulation A | 0.0 | 20.238 | Percentage of Patients | |
| Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | Part 1: Bimatoprost Formulation B | 0.0 | 23.460 | Percentage of Patients | |
| Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | Part 2: Bimatoprost Formulation C | 0.0 | 19.667 | Percentage of Patients | |
| Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Part 1: Bimatoprost Formulation A | Burning | 0 | Patients |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: Bimatoprost Formulation A | 14 | |
| Overall Study | STARTED | Part 1: Bimatoprost Formulation B | 14 | |
| Overall Study | STARTED | Part 2: Bimatoprost Formulation C | 14 | |
| Overall Study | COMPLETED | Part 1: Bimatoprost Formulation A | 13 | |
| Overall Study | COMPLETED | Part 1: Bimatoprost Formulation B | 14 | |
| Overall Study | COMPLETED | Part 2: Bimatoprost Formulation C | 13 | |
| Overall Study | NOT COMPLETED | Part 1: Bimatoprost Formulation A | 1 | |
| Overall Study | NOT COMPLETED | Part 1: Bimatoprost Formulation B | 0 | |
| Overall Study | NOT COMPLETED | Part 2: Bimatoprost Formulation C | 1 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Part 1: Bimatoprost Formulation A | 3 | 14 | |
| other | Headache | Nervous system disorders | Part 1: Bimatoprost Formulation B | 1 | 14 | |
| other | Headache | Nervous system disorders | Part 2: Bimatoprost Formulation C | 1 | 14 | |
| other | Feeling Hot | General disorders | Part 1: Bimatoprost Formulation A | 0 | 14 | |
| other | Feeling Hot | General disorders | Part 1: Bimatoprost Formulation B | 1 | 14 | |
| other | Feeling Hot | General disorders | Part 2: Bimatoprost Formulation C | 0 | 14 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Part 1: Bimatoprost Formulation A | 0 | 14 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Part 1: Bimatoprost Formulation B | 1 | 14 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Part 2: Bimatoprost Formulation C | 0 | 14 | |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Part 1: Bimatoprost Formulation A | 0 | 14 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Bimatoprost Formulation A | ||
| Total, all-cause mortality | Part 1: Bimatoprost Formulation B | ||
| Total, all-cause mortality | Part 2: Bimatoprost Formulation C | ||
| Total, other adverse events | Part 1: Bimatoprost Formulation A | 7 | 14 |
| Total, other adverse events | Part 1: Bimatoprost Formulation B | 6 | 14 |
| Total, other adverse events | Part 2: Bimatoprost Formulation C | 1 | 14 |
| Total, serious adverse events | Part 1: Bimatoprost Formulation A | 0 | 14 |
| Total, serious adverse events | Part 1: Bimatoprost Formulation B | 0 | 14 |
| Total, serious adverse events | Part 2: Bimatoprost Formulation C | 0 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01189279
GET https://conductscience.org/api/trials/v1/NCT01189279/results?page=2