Keywords
eyelash rejuvenation - prostaglandin - Trulush - bimatoprost
Introduction
Eyelash serves an important biological function and is an important aesthetic feature.
The state of eyelash can affect an individual's self-image. To achieve longer, fuller
eyelashes, available modalities include use of cosmetics, eyelash extensions, permanent
pigment tattooing, and eyelash transplants.[1] However, there is no standardized evidence-based treatment for pharmaceutical eyelash
rejuvenation.
Bimatoprost ophthalmic solution 0.03% is an ocular hypotensive agent used worldwide
as a second-line treatment of open-angle glaucoma and ocular hypertension.[2] Eyelash growth was the most frequently reported adverse outcome during these studies.[3]
Animal studies and recent Food and Drug Administration phase 3 clinical trials have
shown that bimatoprost increases the percentage of eyelash and eyebrow follicles in
the anagen phase. This results in increase in its length. It also increases the size
of the dermal papilla and hair bulb resulting in thicker and fuller eyelashes. In
addition, bimatoprost induced melanogenesis of eyelash follicles resulting in darker
eyelashes.[4]
Previous clinical trials have proven that bimatoprost 0.03% is associated with increased
growth of eyelashes when applied topically over the upper eyelash line resulting in
longer, thicker, and darker eyelashes. Therefore, the use of bimatoprost 0.03% has
been considered for improvement in eyelash rejuvenation.
Also, previous studies focused on topical bimatoprost 0.03% to determine prominence
of eyelash growth.[5] Most studies report objective assessment and do not report on the satisfaction score
of subjects.[6] We did not find any studies with subjective as well as objective assessment with
topical application of bimatoprost 0.03% for eyelash enhancement, especially among
Indian population.
Therefore, we aim to study the efficacy and safety of topical application of bimatoprost
0.03% to the upper eyelash line for aesthetic eyelash rejuvenation among Indian population
that is based upon subjective and objective evaluation and assessment.
Materials and Methods
Study Design
This is a prospective pilot study conducted over 12 weeks. Subjects above 15 years
of age, desirous of improving their natural eyelashes were included in the study.
Those excluded from the study were individuals previously diagnosed with glaucoma
or ocular hypertension, any known hypersensitivity to bimatoprost 0.03%, history of
any uncontrolled systemic disease or abnormality, pregnant or lactating women, or
those planning a pregnancy, or not using reliable form of birth control, history of
nonsurgical eyelash enhancement procedure, any previous trauma to the upper eyelid,
or history of permanent makeup procedure of eyelids.
Treatment Protocol
Informed consent was taken from all the subjects. The subjects were provided with
two vials labeled “A” and “B” at the beginning of this study. Vial “A” contained only
the vehicle without bimatoprost 0.03% and vial “B” contained bimatoprost 0.03% as
the active agent.
Subjects were instructed to apply contents of vial “A” on the base of the right eyelash
line and those of vial “B” on the base of the left eyelash line with the applicator
included with the vials, in the evening, once daily for 4 weeks. At the end of 4th
week the subjects were instructed to apply contents of vial “A” on the base of the
left eyelash line and those of vial “B” on the base of the right eyelash line as before,
in the evening, once daily for 4 weeks. They were then asked to discontinue the application
at the end of 8 weeks and were called for final review at 12 weeks.
Clinical Examination
All the subjects were reviewed pretreatment (baseline), at 4 weeks, 8 weeks, and then
at 12 weeks (end of study). At each review the subjects reported on apparent improvement
and adverse effects if any. Digital images were also taken at each of these review
points under standard conditions with DSLR (digital single-lens reflex) camera. All
the above data was transferred onto a master sheet.
Photographic Documentation and Analysis
The digital images of the subjects were documented and used for comparison of all
three parameters of length, darkness, and density using ImageJ software. The scores
obtained were averaged for each follow-up. The mean average for the length, darkness,
and density of eyelashes was calculated. Mean average for eyelash satisfaction as
per the questionnaire for pretreatment and at 12 weeks was calculated.
Health Outcome Questionnaire
To track adverse effects health outcome questionnaire was provided to the patients.
Subjects were asked to answer the questionnaire at weeks 4, 8, and 12.
Eyelash Satisfaction Questionnaire
To assess subjects' satisfaction with the treatment and subjective evaluation of their
eyelashes appearance at 12th week, the Eyelash Satisfaction Questionnaire (ESQ) was
given to the patients at each follow-up.
Results
Patient Demographics
Nine out of 10 patients enrolled in the study were women. Based on the medical histories
collected all subjects were in good general health.
Adverse Effects
Subjects 1, 4, and 6 reported burning sensation after 3rd and 2nd follow-up, respectively.
As per subject 1 the stinging lasted for 1 to 2 minutes and was barely noticeable.
Subjects 4 and 6 reported that the stinging lasted for less than a minute and was
barely noticeable. Remaining 7 subjects did not report any stinging/burning.
Questionnaire Responses
Subjects reported significantly greater improvements from baseline. Upon final review
at 12 weeks' follow-up, 7 subjects reported overall significant improvement, 2 subjects
reported marked improvement, and 1 subject reported moderate improvement in all three
parameters.
Subjective evaluation determining the patient satisfaction with respect to length,
density, and darkness of the eyelashes:
[Fig. 1] represents mean change in eyelash satisfaction questionnaire from baseline to 12th
week.
Fig. 1 The graph depicts the mean change in the Eyelash Satisfaction Questionnaire from
baseline (pretreatment) to the 12th week (posttreatment follow-up) in 10 patients.
At baseline, the mean score was 1.273, while at the 12th week, it increased to 1.674.
The improvement in mean change reflects subjective satisfaction in all three parameters
(length, darkness, and density).
Photographic assessment:
Objective evaluation using ImageJ analysis software determining the length, darkness,
density of the eyelash.
[Fig. 2]: Mean change from baseline to third follow-up in eyelash length, darkness, and density.
Fig. 2 The graph represents the objective evaluation of all three parameters at baseline,
1st follow-up (4th week), 2nd follow-up (8th week), and 3rd follow-up (12th week)
by comparing change in mean at different follow-ups. The average mean at baseline
for eyelash length, darkness, and density was 7.39, 12.5, and 138.29, respectively,
whereas after 12 weeks it was increased to 9.37, 16.85, and 176.25, respectively.
[Fig. 3A] and [3B] represents effect of Bimatoprost on eyelash length, darkness and density at 12th
week on 5 study subjects.
Fig. 3 Representation of the effects of bimatoprost in patients 1, 2, and 3 (A). Representation of the effects of bimatoprost in patients 4 and 5 (B).
Discussion
Bimatoprost 0.03% is an ophthalmic solution used for the treatment of glaucoma and
ocular hypertension. It was accidentally found to result in eyelash enhancement as
a side effect in patients of glaucoma.
A research paper by Johnstone has highlighted hypertrichosis and pigmentation effects
linked to prostaglandin analogs like latanoprost, providing foundational knowledge
of prostaglandin-induced follicular activity.[7] Further supporting this, a clinical trial reported that 4% of patients suffered
from redness and itching in the eye after application of LATISSE (bimatoprost 0.03%).[8] However, the Wester et al study provided important safety data, finding no significant
ocular adverse events in subjects who completed the study. While there were no periocular
or iris pigmentation changes documented during study visits, two patients noted subjective
periocular changes between visits, which they self-treated and which did not recur.
Importantly, these changes were not deemed significant by the patients themselves.[9]
In contrast, our study on Trulush 0.03% revealed distinct safety outcomes. None of
our subjects reported redness and itching after the application of Trulush. Three
out of 10 patients reported a stinging sensation after its application for 1 to 2 minutes,
which subsided on its own. However, a larger subject cohort needs to be studied to
validate these findings. Additionally, variations in application, duration of application,
and persistence of results after discontinuation need further investigation.
While safety and tolerability form a crucial part of the evaluation, subject satisfaction
is equally important in assessing product efficacy. The ESQ findings ([Fig. 1]) demonstrate a significant improvement in subject satisfaction from baseline to
the 12th week. The mean ESQ score increased from approximately 1.273 at baseline to
1.674 at 12 weeks, indicating a noticeable enhancement in perceived eyelash length,
density, and overall satisfaction. These results suggest that Trulush 0.03% effectively
meets user expectations for eyelash enhancement.
In terms of formulation, Trulush 0.03% offers a key point of differentiation compared
with established formulations like LATISSE and Lumigan. Both LATISSE and Lumigan formulations
rely on bimatoprost 0.03% as the active ingredient, supplemented with similar excipients
such as benzalkonium chloride, sodium chloride, sodium phosphate, and citric acid.
Trulush, while containing the same concentration of bimatoprost, differentiates itself
by incorporating sodium hyaluronate, a known humectant. This addition enhances the
product's hydrating properties, potentially improving user comfort and tolerability.
To truly assess the efficacy and safety of Trulush 0.03% relative to established formulations,
comparative studies are essential.
Conclusion
Bimatoprost 0.03%, in the available formulation (Trulush), is found to be effective
for eyelash rejuvenation by topical application and demonstrates subjective as well
as objective increase in length, darkness, and density of the eyelashes. There are
no significant associated side effects.
