Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide f2 alpha agonists

a technology of prostamide and alpha agonist, which is applied in the field of postchemotherapeutic hypotrichosis treatment, can solve the problems of chemotherapy-induced hair loss, patchy hair loss, damage to the hair follicle components, etc., and achieve the effect of preventing the loss of eyelashes

a technology of prostamide and alpha agonist, which is applied in the field of postchemotherapeutic hypotrichosis treatment, can solve the problems of chemotherapy-induced hair loss, patchy hair loss, damage to the hair follicle components, etc., and achieve the effect of preventing the loss of eyelashes

US20160279143A1Inactive Publication Date: 2016-09-29ALLERGAN INC
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  • Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide f2 alpha agonists
  • Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide f2 alpha agonists
  • Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide f2 alpha agonists

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Experimental program
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Effect test

example 1

[0057]

TABLE IList of Components and Quantitative CompositionConcen-Concen-trationtrationIngredients(% w / v)(mg / mL)FunctionActive ingredientBimatoprosta0.030.3ActiveingredientOther ingredientsBenzalkonium chlorideb0.0050.05PreservativeSodium phosphate0.2682.68BufferingdibasicheptahydrateagentCitric acid monohydrate0.0140.14BufferingagentSodium chloride0.838.3TonicityagentHydrochloric acidc and / or sodiumAdjust to pH 7.2-7.4pH adjusterhydroxidecPurified waterq.s. adq.s. adVehicle100%1 mL

Clinical Data:

[0058]A clinical study was conducted that demonstrated the clinical benefits of bimatoprost 0.03% solution in treating eyelash loss resulting from chemotherapy treatment.

Study Design and Structure:

[0059]This was a 1-year, multicenter, double-masked, randomized, parallel-group study to evaluate the safety and efficacy of bimatoprost solution 0.03% in increasing overall eyelash prominence following dermal application to the upper eyelid margins in normal adults and postchemotherapy adults exh...

example 2

[0086]This is a long-term safety and efficacy study of bimatoprost ophthalmic solution 0.03% (LATISSEĀ®) bimtoprost carried out in idiopathic and post-chemotherapy hypotrichosis populations. In this study, eyelash loss from chemotherapy was studied.

Study Design:

[0087]A one-year, multicenter, randomized, double-masked, vehicle-controlled study. Adult post-chemotherapy and idiopathic eyelash hypotrichosis subjects were enrolled based on their score of 1 or 2 on a four point ordinal Global Eyelash Assessment (GEA) scale, and in addition having a low score on a PRO measure associated with ā€˜psychological impactā€™ of the condition, a domain-2 of the Eyelash Satisfaction Questionnaire (ESQ). The study involved two treatment periods of six months each. In the first treatment period, subjects for both populations were randomized 3:1 for QD bimatoprost: vehicle treatment. In the second 6-month treatment period, all subjects were moved to bimatoprost treatment, except for a group of bimatoprost ...

example iii

Objective:

[0100]To evaluate long-term safety and efficacy of bimatoprost among subjects with idiopathic or chemotherapy-induced hypotrichosis.

Methods:

[0101]This multicenter, double-masked, randomized, parallel-group study included two 6-month treatment periods. Subjects with idiopathic hypotrichosis were randomized 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 randomized 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 (i.e.,...

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Abstract

The present invention is directed to compositions and methods for the treatment of post-chemotherapeutic hypotrichosis. More specifically, the present invention is directed to the use of compositions comprising bimatoprost for the treatment of post-chemotherapeutic hypotrichosis which may be applied before, during and after receiving chemotherapeutic treatment.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 14 / 251,394, filed Apr. 11, 2014, which in turn is a continuation-in-part of U.S. patent application Ser. No. 14 / 199,402, filed Mar. 6, 2014, which is a continuation of U.S. patent application Ser. No. 13 / 738,732, filed Jan. 10, 2013, now U.S. Pat. No. 8,758,733 issued Jun. 24, 2014, which claims priority to U.S. Provisional Application No. 61 / 611,920, filed Mar. 16, 2012, and U.S. Provisional Application No. 61 / 584,877, filed Jan. 10, 2012. This application is also a continuation-in-part of U.S. patent application Ser. No. 13 / 937,512, filed Jul. 9, 2013, now U.S. Pat. No. 8,926,953 issued Jan. 6, 2015, which is a continuation of U.S. patent application Ser. No. 13 / 441,783, filed Apr. 6, 2012, now U.S. Pat. No. 8,632,760, issued Jan. 21, 2014, which is a continuation of U.S. Pptent application Ser. No. 13 / 356,284, filed Jan. 23, 2012, now U.S. Pat. No. 8,263,054, issued...

Claims

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Application Information

Patent Timeline
29 Sep 2016
Publication
US20160279143A1
IPC
A61K31/5575; A61K9/00
CPC
A61K9/0048; A61K31/5575; A61K8/42; A61K8/4953; A61Q1/10; A61K8/63; A61Q7/00; A61K9/0014
Inventors
AHLUWALIA, GURPREET; BEDDINGFIELD, FREDERICK C.