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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 randomised controlled trial

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 randomised controlled trial
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 randomised controlled trial
BACKGROUND: Bimatoprost ophthalmic solution 0.03% is approved in several countries for treating eyelash hypotrichosis. Previous trials were limited to 4 months of treatment and primarily idiopathic hypotrichosis.

OBJECTIVE: Evaluate long-term safety and efficacy of bimatoprost among subjects with idiopathic or chemotherapy-induced hypotrichosis.

METHODS: This multicentre, double-masked, randomised, parallel-group study included two 6-month treatment periods. Subjects with idiopathic hypotrichosis were randomised to 3 treatment groups: 1) treatment period 1 (TP1) and TP2: bimatoprost; 2) TP1: bimatoprost; TP2: vehicle; and 3) TP1: vehicle; TP2: bimatoprost. Subjects with chemotherapy-induced hypotrichosis were randomised to 2 treatment groups: 1) TP1: bimatoprost or vehicle; and 2) TP2: bimatoprost. The primary endpoint was a composite of at least a 1-grade improvement in investigator-assessed Global Eyelash Assessment (GEA), and at least a 3-point improvement in subject-reported Eyelash Satisfaction Questionnaire (ESQ) Domain 2 (self-perceived confidence, attractiveness, and professionalism) at month 4. Secondary measures included digitally assessed eyelash characteristics (ie, eyelash length, fullness, and darkness).

RESULTS: The study randomised 368 subjects. The primary efficacy endpoint was met in both populations (responder rates: idiopathic: 40.2% bimatoprost vs 6.8% vehicle; post-chemotherapy: 37.5% bimatoprost vs 18.2% vehicle). Efficacy by month 6 was maintained (idiopathic) or enhanced (post-chemotherapy) at 12 months. Treatment effects were maintained for approximately 2 months but markedly diminished 4 to 6 months following treatment cessation in subjects 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 subjects with idiopathic and chemotherapy-induced hypotrichosis.
0007-0963
Glaser, D.A.
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Hossain, Parwez
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Perkins, W.
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Griffiths, T.
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Ahluwalia, G.
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Weng, E.
bed073cd-c0e0-47ae-9b33-a983122de461
Beddingfield, F.C.
377b3185-cca7-4952-a27b-9ce3fd06a077
Glaser, D.A.
0bd8c2a0-b9c3-4624-8b77-f54c5b0b1579
Hossain, Parwez
563de5fc-84ad-4539-9228-bde0237eaf51
Perkins, W.
b2779ed4-a351-4fa9-9d90-7c60aeb89659
Griffiths, T.
62fb7ece-94e1-4294-acd0-c6b54f116728
Ahluwalia, G.
2a40a465-4028-4328-8f1f-17edbedbc79c
Weng, E.
bed073cd-c0e0-47ae-9b33-a983122de461
Beddingfield, F.C.
377b3185-cca7-4952-a27b-9ce3fd06a077

Glaser, D.A., Hossain, Parwez, Perkins, W., Griffiths, T., Ahluwalia, G., Weng, E. and Beddingfield, F.C. (2015) 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 randomised controlled trial. British Journal of Dermatology. (doi:10.1111/bjd.13443). (PMID:25296533)

Record type: Article

Abstract

BACKGROUND: Bimatoprost ophthalmic solution 0.03% is approved in several countries for treating eyelash hypotrichosis. Previous trials were limited to 4 months of treatment and primarily idiopathic hypotrichosis.

OBJECTIVE: Evaluate long-term safety and efficacy of bimatoprost among subjects with idiopathic or chemotherapy-induced hypotrichosis.

METHODS: This multicentre, double-masked, randomised, parallel-group study included two 6-month treatment periods. Subjects with idiopathic hypotrichosis were randomised to 3 treatment groups: 1) treatment period 1 (TP1) and TP2: bimatoprost; 2) TP1: bimatoprost; TP2: vehicle; and 3) TP1: vehicle; TP2: bimatoprost. Subjects with chemotherapy-induced hypotrichosis were randomised to 2 treatment groups: 1) TP1: bimatoprost or vehicle; and 2) TP2: bimatoprost. The primary endpoint was a composite of at least a 1-grade improvement in investigator-assessed Global Eyelash Assessment (GEA), and at least a 3-point improvement in subject-reported Eyelash Satisfaction Questionnaire (ESQ) Domain 2 (self-perceived confidence, attractiveness, and professionalism) at month 4. Secondary measures included digitally assessed eyelash characteristics (ie, eyelash length, fullness, and darkness).

RESULTS: The study randomised 368 subjects. The primary efficacy endpoint was met in both populations (responder rates: idiopathic: 40.2% bimatoprost vs 6.8% vehicle; post-chemotherapy: 37.5% bimatoprost vs 18.2% vehicle). Efficacy by month 6 was maintained (idiopathic) or enhanced (post-chemotherapy) at 12 months. Treatment effects were maintained for approximately 2 months but markedly diminished 4 to 6 months following treatment cessation in subjects 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 subjects with idiopathic and chemotherapy-induced hypotrichosis.

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More information

Accepted/In Press date: 24 September 2014
e-pub ahead of print date: 7 March 2015
Published date: 11 May 2015
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 369963
URI: https://eprints.soton.ac.uk/id/eprint/369963
ISSN: 0007-0963
PURE UUID: fa428e69-dd21-4bdf-a1ce-1b78d5f71fe3
ORCID for Parwez Hossain: ORCID iD orcid.org/0000-0002-3131-2395

Catalogue record

Date deposited: 15 Oct 2014 10:22
Last modified: 20 Jul 2019 00:55

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Contributors

Author: D.A. Glaser
Author: Parwez Hossain ORCID iD
Author: W. Perkins
Author: T. Griffiths
Author: G. Ahluwalia
Author: E. Weng
Author: F.C. Beddingfield

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