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Br J Dermatol. 2015;172(5):1384-94. doi: 10.1111/bjd.13443. Epub 2015 Mar 7.

Long-term safety and efficacy of bimatoprost solution 0·03% application to the eyelid margin for the treatment of idiopathic and chemotherapy-induced eyelash hypotrichosis: a randomized controlled trial.

Author information

1
Department of Dermatology, Saint Louis University, St Louis, MO, U.S.A.
2
NIHR Wellcome Trust Clinical Research Facility, Southampton General Hospital, University of Southampton, Southampton, U.K.
3
Department of Dermatology, Nottingham University Hospitals, Nottingham, U.K.
4
The Dermatology Centre, Salford Royal NHS Foundation Trust, Salford, U.K.
5
University of Manchester, Manchester, U.K.
6
Allergan, Inc., Irvine, CA, U.S.A.
7
Department of Medicine, Division of Dermatology, David Geffen School of Medicine, University of California, Los Angeles, CA, U.S.A.
8
Kythera Biopharmaceuticals, Inc., Westlake Village, CA, U.S.A.

Abstract

BACKGROUND:

Bimatoprost ophthalmic solution 0·03% is approved in several countries for the treatment of eyelash hypotrichosis. Previous trials were limited to 4 months of treatment and primarily idiopathic hypotrichosis.

OBJECTIVES:

To evaluate the long-term safety and efficacy of bimatoprost in patients with idiopathic or chemotherapy-induced hypotrichosis.

METHODS:

This multicentre, double-masked, randomized, parallel-group study included two 6-month treatment periods [treatment period 1 (TP1) and treatment period 2 (TP2)]. Patients with idiopathic hypotrichosis were randomized to three treatment groups: (i) bimatoprost (TP1 and TP2); (ii) bimatoprost (TP1) and vehicle (TP2); and (iii) vehicle (TP1) and bimatoprost (TP2). Patients with chemotherapy-induced hypotrichosis were randomized to two treatment groups: (i) bimatoprost or vehicle (TP1) and (ii) bimatoprost (TP2). Primary end point was a composite of at least a one-grade improvement in investigator-assessed Global Eyelash Assessment and at least a three-point improvement in patient-reported Eyelash Satisfaction Questionnaire Domain 2 at month 4. Secondary measures included digitally assessed eyelash characteristics.

RESULTS:

The primary efficacy end point was met in both populations (idiopathic responder rate was 40·2% for bimatoprost vs. 6·8% for vehicle; postchemotherapy responder rate was 37·5% for bimatoprost vs. 18·2% for vehicle). Efficacy by month 6 was maintained (idiopathic) or enhanced (postchemotherapy) at 12 months. Treatment effects were maintained for approximately 2 months but markedly diminished 4-6 months following treatment cessation in patients with idiopathic hypotrichosis. No drug-related serious adverse events were reported.

CONCLUSIONS:

Daily treatment with bimatoprost ophthalmic solution 0·03% for 1 year was effective and well tolerated in patients with idiopathic and chemotherapy-induced hypotrichosis.

PMID:
25296533
PMCID:
PMC4832276
DOI:
10.1111/bjd.13443
[Indexed for MEDLINE]
Free PMC Article

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