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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

Inactive Publication Date: 2016-09-29
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text is about a method where a small amount of bimatoprost is applied before chemotherapy treatment to promote the growth of eyelashes. The method showed that patients who received bimatoprost had more eyelash growth compared to patients who did not receive it.

Problems solved by technology

In contrast to the natural eyelash hypotrichosis condition where the hair follicle is normal except it produces shorter and inadequate amount of eyelashes, chemotherapy treatment results in damage to the hair follicle components that make the hair fiber such that after the chemotherapy drug treatment, the natural eyelashes either fall off completely or result in patchy hair loss.
Chemotherapy-induced hair loss is known to result from the direct toxic insult to rapidly dividing cells of the hair follicle (Trueb, 2009).
While eyelash loss can be part of the experience of chemotherapy-induced hair loss (Trueb, 2009), there are no reliable data in the published literature that specifically address the incidence of eyelash loss due to chemotherapy.
However, the known mechanism by which chemotherapy induces alopecia indicates that any active hair follicle in anagen would be susceptible, including scalp, body, eyebrow, and eyelash hair.
For most cancer treatments, after the chemotherapy regimen is completed, the patient recovers from the treatment side effects relatively quickly, ie, most side effects of chemotherapy resolve within a few weeks of the last treatment; however, hair growth can continue to be depressed for a period of time.
Moreover, when the hair does recover early, it is generally much finer and thinner than the original hair and can take several hair cycles to restore to the pre-chemotherapy levels.
The loss not just of scalp hair but body hair can lead to psychosocial problems such as diminished quality of life expressed as anxiety, depression, and low self-esteem (Ulrich et al, 2008).
In the focus group studies, patients stated that the loss of eyelashes and eyebrows was worse than the loss of scalp hair because the latter could be easily concealed by a wig, whereas there was no way to make their eyelashes look “normal”.
False eyelashes were not a reasonable treatment in the opinion of the respondents because they did not have enough natural eyelashes to help the glue adhere to their eyelid margins.
Moreover, such measures can result in severe irritation and skin damage and are therefore not ideal, especially in the post-chemotherapy population.
Even though they noticed some re-growth, most complained that their eyelashes were sparse (ie, gaps between lashes), short, and lighter in color.
Currently there are no treatments available for chemotherapy induced eyelash loss.

Method used

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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

Examples

Experimental program
Comparison scheme
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% (LATISSE®) 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 ‘psychological impact’ 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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PUM

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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

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/5575A61K9/00
CPCA61K9/0048A61K31/5575A61K8/42A61K8/4953A61Q1/10A61K8/63A61Q7/00A61K9/0014A61K31/165A61K9/08A61K2800/10
Inventor AHLUWALIA, GURPREETBEDDINGFIELD, FREDERICK C.EDWARDS, SYDNEY G.WHITCUP, SCOTT M.
Owner ALLERGAN INC
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