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Prostaglandin Analog

Bimatoprost for Hypopigmented Scars

Phase 2

Recruiting

Research Sponsored by Medstar Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

2 different hypopigmented scars (at least 100cm2 each) with at least 2 inches of normal skin or hyperpigmented scar surrounding each hypopigmented scar

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow-up number 6, an average of 8 months

Awards & highlights

Study Summary

This trial will test if laser + bimatoprost can lighten hypo-pigmented burn scars after 6 treatments over 14 days.

Who is the study for?

This trial is for adults with hypopigmented scars from burns or other trauma, who have two such scars each at least 100cm2 in size. Participants must not be pregnant, breastfeeding, imprisoned, allergic to bimatoprost or lidocaine, and the scars should not be on the face or genitalia.Check my eligibility

What is being tested?

The study tests if Bimatoprost can improve pigmentation in burn scars compared to saline when delivered through laser-created channels. Each participant will have one scar treated with Bimatoprost and another with saline as a control over six sessions spaced 4-6 weeks apart.See study design

What are the potential side effects?

Bimatoprost may cause side effects like darkening of the skin around eyes, eye redness and itching, eyelash growth where applied; however specific side effects related to scar treatment are monitored during this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have 2 large light-colored scars with normal or darker skin around them.

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I have a light-colored scar from a skin injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow-up number 6, an average of 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow-up number 6, an average of 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up number 6, an average of 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area of pigmentation

Secondary outcome measures

Differential gene expression of tyrosinase

Differential gene expression of tyrosinase-related protein 1

Differential gene expression of tyrosinase-related protein 2

+1 more

Other outcome measures

Non-invasive measurement of elasticity

Non-invasive measurement of melanin

Non-invasive measurement of stiffness

+2 more

Side effects data

From 2021 Phase 3 trial • 485 Patients • NCT03825380

Conjunctival hyperaemia

100%

80%

60%

40%

20%

Study treatment Arm

T4032

Lumigan®

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Bimatoprost will be delivered to the scars using laser-assisted drug delivery in this arm

Group II: ControlPlacebo Group1 Intervention

Saline control will be delivered to the scars using laser-assisted drug delivery in this arm

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bimatoprost

2018

Completed Phase 4

~3930

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Latham FundUNKNOWN

Medstar Health Research InstituteLead Sponsor

189 Previous Clinical Trials

115,548 Total Patients Enrolled

2 Trials studying Scarring

30 Patients Enrolled for Scarring

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are participating in this research project?

"Yes, as per the clinicaltrials.gov database, this medical trial is still inviting participants to join. It was initially posted on July 18th 2023 and most recently edited on November 2nd 2023; there are 25 spots available at a single site."

Answered by AI

Has this treatment attained official sanction from the FDA?

"This treatment's safety was rated at 2, as it is only in phase 2 of clinical trials; while there are some preliminary data suggesting its safety, no efficacy has been established."

Answered by AI

Is it feasible to participate in this endeavor at present?

"Affirmative, the clinicaltrials.gov records demonstrate that this research is actively enrolling patients. This trial was first introduced on July 18th 2023 and its information has been recently revised as of November 2nd 2023. The study requires 25 participants from one site to partake in it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Hypopigmented Scars With Bimatoprost

Bonnie Carney 2023. "Treatment of Hypopigmented Scars With Bimatoprost". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06122090.

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