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NCT Number: NCT01189279

Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia

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.

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Key information

Conditions

Alopecia Alopecia, Androgenetic Baldness Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tempe, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

bimatoprost Formulation A

Drug

bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.

bimatoprost Formulation B

Drug

bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.

bimatoprost Formulation C

Drug

bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings

    Time frame: 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.

  2. Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment

    Time frame: 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.

  3. Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 26, 2010
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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