Bimatoprost for Hypopigmented Scars

Recruiting at 1 trial location

Overseen By Alison Ross, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medstar Health Research Institute

Disqualifiers: Facial/genital scars, Bimatoprost allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6-12 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat light-colored scars from burns. Researchers are testing whether bimatoprost (also known as Latisse, Lumigan, or Durysta) can make these scars less noticeable by darkening them. Two scars will receive treatment: one with bimatoprost and the other with a harmless liquid (saline), both applied through laser channels. Individuals with two light-colored scars from skin injuries, each at least 30 cm² in size and not located on the face or private areas, may qualify for this study. The goal is to determine if bimatoprost can safely improve scar appearance over several sessions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in scar treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that bimatoprost is likely to be safe for humans?

Research has shown that bimatoprost is generally safe for people. In studies, patients experienced good results with no reported negative effects when using bimatoprost alongside laser treatment. However, some possible side effects exist. For instance, bimatoprost can cause changes in the fat around the eyes, which might not resolve on their own. More research is needed to understand its long-term safety, but it appears well-tolerated so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hypopigmented scars?

Most treatments for hypopigmented scars focus on topical applications or invasive procedures to stimulate pigmentation. However, Bimatoprost is unique because it leverages a new delivery method—laser-assisted drug delivery—which allows the medication to penetrate deeper into the skin, potentially enhancing its effectiveness. Bimatoprost, originally used for eyelash growth, may promote pigmentation by increasing melanin production. Researchers are excited about this treatment because it offers a non-invasive alternative that could yield faster and more noticeable results compared to traditional methods.

What evidence suggests that bimatoprost might be an effective treatment for hypopigmented scars?

Research shows that bimatoprost can help improve light-colored scars. In this trial, one group of participants will receive bimatoprost delivered to the scars using laser-assisted drug delivery. Previous studies have shown that patients noticed significant improvements in scar color within three months of using bimatoprost cream. Another report found that people who had laser treatment along with bimatoprost application experienced visible improvements in scars on their face and neck. Additionally, follow-up results from that study showed that 11 out of 14 patients had more than 50% improvement in scar color 12 weeks after treatment. These findings suggest that bimatoprost, especially when combined with laser treatment, could be a promising option for improving the appearance of light-colored scars. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

Exclusion Criteria

I have a light-colored scar on my face or genital area.

You are allergic to lidocaine.

Women who could become pregnant have a positive urine pregnancy test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-treatment

Pre-treatment visit to collect information about scars, including pictures, non-invasive probes, imaging, questionnaires, and blood draw

1 day

1 visit (in-person)

Treatment

Participants receive 6 laser treatments with bimatoprost application over 6-12 months, with 14 days of twice-daily application post-treatment

6-12 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including melanin evaluation and biopsies

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bimatoprost

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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

Group II: Control Placebo Group 1 Intervention

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

Bimatoprost is already approved in United States, European Union for the following indications:

Approved in United States as Lumigan for:

• Glaucoma - Open Angle
• Intraocular Hypertension
• Eyelash Hypotrichosis

Approved in European Union as Lumigan for:

• Glaucoma - Open Angle
• Intraocular Hypertension
• Eyelash Hypotrichosis

Approved in United States as Durysta for:

• Glaucoma - Open Angle
• Intraocular Hypertension

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Latham Fund

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Topical application of bimatoprost (Latisse®) not only enhances eyelashes but also significantly improves the overall appearance of the periorbital area, marking a novel finding in dermatology and plastic surgery.

The authors suggest renaming the condition associated with bimatoprost from prostaglandin-associated periorbitopathy (PAP) to prostaglandin-associated periorbital syndrome (PAPS) to reflect both the potential benefits and risks, indicating that with careful selection and dosing, bimatoprost can be beneficial for cosmetic purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost-induced chemical blepharoplasty. Sarnoff, DS., Gotkin, RH.[2022]

In a pilot study involving 11 Japanese female patients with refractory leukoderma caused by rhododendrol (RD), bimatoprost showed slight improvement in skin repigmentation for some participants after 6 months of treatment.

While bimatoprost was applied daily for the first 3 months and then twice daily for the next 3 months, the limited number of patients suggests that further research is needed to confirm its effectiveness for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label pilot study to evaluate the effectiveness of topical bimatoprost on rhododendrol-induced refractory leukoderma. Fukaya, S., Kamata, M., Kasanuki, T., et al.[2019]

A study involving 50 women using topical bimatoprost for an average of 4.59 years found no changes in iris pigmentation, indicating that its cosmetic use is safe in this regard.

The results suggest that the long-term cutaneous application of bimatoprost carries minimal risk for iris pigmentation changes, which is a concern noted in its use for glaucoma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Evaluation of Topical Bimatoprost and Iris Pigmentation Change. Zaleski-Larsen, LA., Ruth, NH., Fabi, SG.[2018]

Bimatoprost 0.03% ophthalmic solution, used once daily for treating eyelash hypotrichosis, demonstrated a favorable safety profile with similar rates of adverse events compared to a vehicle control in a pooled analysis of six clinical studies involving 1,059 participants.

Common mild adverse events included conjunctival hyperemia and eyelid pruritus, mostly occurring early in treatment and reversible upon discontinuation, indicating that bimatoprost is generally well-tolerated for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost 0.03% for the Treatment of Eyelash Hypotrichosis: A Pooled Safety Analysis of Six Randomized, Double-masked Clinical Trials. Wirta, D., Pariser, DM., Yoelin, SG., et al.[2020]

Bimatoprost, originally used to treat glaucoma, has side effects like increased eyelid pigmentation and hair growth, which have led to new uses in dermatology.

These side effects have opened up potential treatments for conditions like alopecia (hair loss) affecting eyelashes and eyebrows, as well as vitiligo, a skin condition that causes loss of pigmentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost in Dermatology. Jha, AK., Sarkar, R., Udayan, UK., et al.[2022]

In a study of patients treated for 12 months, periocular pigmentation occurred in 1% of those using latanoprost compared to 6% of those using bimatoprost, indicating a significantly lower incidence with latanoprost (p = 0.004).

Both latanoprost and bimatoprost can lead to periocular pigmentation, but latanoprost appears to be a safer option with a lower risk of this side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical impact and incidence of periocular pigmentation associated with either latanoprost or bimatoprost therapy. Sharpe, ED., Reynolds, AC., Skuta, GL., et al.[2018]

Bimatoprost ophthalmic solution 0.01% combined with narrowband ultraviolet B (NB-UVB) phototherapy significantly improved vitiligo lesions in Thai patients, particularly for non-segmental vitiligo, with notable results observed at 3 months and 6 months of treatment.

The study found no reported side effects, indicating that this combination therapy is both safe and effective for treating non-segmental vitiligo in areas of the body other than the face and neck.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of bimatoprost ophthalmic solution combined with NB-UVB phototherapy in non-segmental and segmental vitiligo: a single-blind randomized controlled study. Silpa-Archa, N., Likittanasombat, S., Apinuntham, C., et al.[2023]

Bimatoprost 0.03%, used for treating hypotrichosis and glaucoma, can cause significant periocular fat atrophy, leading to hollowing around the eyes in some patients, as observed in a retrospective review of 7 cases.

Both cosmetic (Latisse) and ophthalmic (Lumigan) formulations of bimatoprost are identical, so patients should be warned about the risk of irreversible fat changes, highlighting the need for careful consideration before prescribing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical bimatoprost 0.03% and iatrogenic eyelid and orbital lipodystrophy. Sira, M., Verity, DH., Malhotra, R.[2016]

In a study of 28 patients with hypopigmented scars, the combination of fractional CO2 laser treatment and latanoprost resulted in over 50% improvement in scar pigmentation for 11 out of 14 patients, showing significant efficacy compared to the placebo group.

Patients treated with the combination therapy reported higher satisfaction scores (6.50) compared to those receiving only the laser treatment (4.57), indicating that the addition of latanoprost enhances patient satisfaction while side effects were mild and temporary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repigmentation of Hypopigmented Scars Using Combination of Fractionated Carbon Dioxide Laser with Topical Latanoprost Vs. Fractionated Carbon Dioxide Laser Alone. Siadat, AH., Rezaei, R., Asilian, A., et al.[2018]

In a study of 17 subjects with alopecia areata totalis and universalis, topical bimatoprost was found to be effective in increasing the length and thickness of existing eyelashes, but it did not induce the regrowth of new eyelashes.

The treatment was applied nightly for an average of 30.6 weeks, and it was noted that only subjects with eyelashes present at the start of the study saw improvements, highlighting the limitations of bimatoprost in cases of complete eyelash loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical bimatoprost in the treatment of eyelash loss in alopecia totalis and universalis: A prospective, open-label study. Ricar, J., Cetkovska, P., Hordinsky, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11586295/

Hypopigmented Burn Scar Successfully Repigmented With ... Today, we report significant improvement in bilateral hypopigmented burn scars of the arms within three months of treatment with topical bimatoprost 0.03% ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352512621004781

Case report Bimatoprost drug delivery with fractional laser ... ... bimatoprost helped improve hypopigmented scars. Patients in this study with scars on the face and neck underwent 10 and 4 sessions, respectively, of laser ...

3. cureus.com cureus.com/articles/389821-non-ablative-1927-nm-fractional-thulium-laser-with-bimatoprost-to-treat-a-hypopigmented-burn-scar

Non-ablative 1927 nm Fractional Thulium Laser With ... This case report details the effectiveness of a three-step, minimally invasive protocol to treat hypopigmented burn scars: fractional laser- ...

4. journals.lww.com journals.lww.com/ijd/fulltext/2015/60040/repigmentation_of_hypopigmented_scars_using.8.aspx

Repigmentation of Hypopigmented Scars Using ... Follow-up results 12 weeks after the last treatment session demonstrated that 11 of the 14 patients in group A had more than 50% improvement in hypopigmentation ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10503939/

Laser-Assisted Prostaglandin Analogs in the Treatment of ... Conclusion. All studies evaluated demonstrated favorable treatment outcomes with no reported adverse events. Additional, large randomized controlled trials are ...

6. jcadonline.com jcadonline.com/laser-assisted-treatment-hypopigmented-review/

Laser-Assisted Prostaglandin Analogs in the Treatment ... Additional, large randomized controlled trials are needed to fully assess the effectiveness and long-term safety of PGF2α agonists for hypopigmented scars.

7. withpower.com withpower.com/trial/phase-2-hypopigmentation-6-2023-a29f5

Bimatoprost for Hypopigmented Scars Bimatoprost is generally safe for use in humans, but it can cause side effects like changes in the fat around the eyes, which may be irreversible. In some ...