Study of Bimatoprost Gel on Eyelash Growth

Duke University

Status and phase: Completed; Phase 3

Conditions: Madarosis; Hypotrichosis

Treatments: Drug: Bimatoprost eyelash gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01200251

71320 (Registry Identifier)

9459

Details and patient eligibility

About

A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 YO females
• madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer
• only breast cancer patients

Exclusion criteria

• inability to follow up, apply gel
• active eye/eyelid infection or inflammatory process
• cancer not related to breast cancer, healthy patients
• males

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Bimatoprost treated eyelid

Experimental group

Description:

one eyelid of the patient was randomized to the treatment arm and given the gel to use

Treatment:

Drug: Bimatoprost eyelash gel

control arm - no gel

No Intervention group

Description:

the other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids