Bimatoprost for Hypopigmented Scars

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

Trial Summary

What is the purpose of this trial?

Patients who have hypo-pigmented burn scar will have two scars chosen and randomized to treated scar and control scar. The subject will then have both scars treated with fractional ablative CO2 laser (FLSR). The treated scar will have bimatoprost delivered through the laser channels, while the control will have the vehicle (normal saline) only delivered. The treatment will continue for 14 days with twice daily application. The scars will then be monitored at a 2-week follow-up visit where levels of melanin will be evaluated. Tissue punch biopsies will also be used to evaluate the mechanism of action of bimatoprost. Treatment will occur for 6 sessions at 4-6 week intervals including follow- up visits and evaluations.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Bimatoprost for treating hypopigmented scars?

Bimatoprost has been shown to increase pigmentation in areas like the eyelids and eyelashes when used for other conditions, suggesting it might help with hypopigmented scars by potentially increasing pigmentation in those areas. ^{1 2 3 4 5}

Is bimatoprost generally safe for use in humans?

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 studies, no side effects were reported, but it's important to be aware of potential risks. ^{2 6 7 8 9}

What makes bimatoprost unique for treating hypopigmented scars?

Bimatoprost is unique for treating hypopigmented scars because it is a prostamide analogue originally used for glaucoma, which has shown potential in dermatology due to its side effects like increased pigmentation. This makes it a novel option for repigmentation, unlike traditional treatments that do not utilize this mechanism. ^{1 2 4 7 10}

Eligibility Criteria

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 am 18 years old or older.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Bimatoprost in Dermatology. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Topical bimatoprost 0.03% and iatrogenic eyelid and orbital lipodystrophy. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Topical bimatoprost in the treatment of eyelash loss in alopecia totalis and universalis: A prospective, open-label study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The clinical impact and incidence of periocular pigmentation associated with either latanoprost or bimatoprost therapy. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Retrospective Evaluation of Topical Bimatoprost and Iris Pigmentation Change. [2018]

6. United States 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. [2020]

7. England 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Bimatoprost-induced chemical blepharoplasty. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Open-label pilot study to evaluate the effectiveness of topical bimatoprost on rhododendrol-induced refractory leukoderma. [2019]

10. India 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. [2018]