Cited by 29Hair Growth and DisordersChemotherapy-related skin toxicityOcular Surface and Contact Lens

Bimatoprost for Eyelash Growth in Japanese Subjects: Two Multicenter Controlled Studies

Open access
Harii, K., Arase, S., Tsuboi, R., Weng, E., Daniels, S., VanDenburgh, A.·2014·Aesthetic Plastic Surgery

Abstract

BACKGROUND: Bimatoprost 0.03% has enhanced eyelash prominence in clinical trials enrolling mostly Caucasian subjects. The studies described in this report evaluated the efficacy and safety of bimatoprost in Japanese subjects with idiopathic and chemotherapy-induced eyelash hypotrichosis. METHODS: In two multicenter, double-masked, randomized, parallel-group studies (study 1: n=173 [idiopathic]; study 2: n=36 [chemotherapy-induced]), subjects received bimatoprost 0.03% or vehicle applied once daily to the upper eyelid margins. The primary efficacy measure was eyelash prominence measured by Global Eyelash Assessment (GEA) scores. Additional measures were eyelash length, thickness, and darkness, assessed by digital image analysis, and patient satisfaction (Eyelash Satisfaction Questionnaire-9). Safety assessments included adverse-event monitoring and ophthalmic examinations. RESULTS: Significantly more bimatoprost-treated subjects had at least a one-grade improvement in GEA score from baseline to month 4 compared with vehicle in study 1 (77.3 vs 17.6%; P<0.001) and study 2 (88.9 vs 27.8%; P<0.001). Bimatoprost-treated subjects had significantly greater increases in eyelash length, thickness, and darkness at the primary time point (month 4 in both studies; all P<0.001, study 1; P≤0.04, study 2). The bimatoprost group showed greater subject satisfaction in both studies. The incidence of adverse events was similar in the two groups. Ophthalmic examination showed slightly greater mean reductions in intraocular pressure (IOP) with bimatoprost than with vehicle, and the reductions were within the normal range for daily IOP fluctuations. CONCLUSION: Bimatoprost 0.03% was shown to be effective and safe in these studies of Japanese subjects with eyelash hypotrichosis. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

AI snapshot

Written from the paper’s full text.

TL;DR

Bimatoprost 0.03 % applied nightly to the upper eyelid margins improved eyelash prominence, length, thickness, and darkness versus vehicle in Japanese subjects with idiopathic or chemotherapy-induced eyelash hypotrichosis. The safety profile was similar between groups, with small IOP reductions within normal daily fluctuation ranges.

Key findings

  • At month 4, significantly more bimatoprost-treated subjects had at least a one-grade GEA improvement versus vehicle in study 1 (77.3 vs 17.6 %; P < 0.001) and study 2 (88.9 vs 27.8 %; P < 0.001).
  • In study 1, bimatoprost produced mean improvements from baseline to month 4 of 1.62 mm (24 %) in upper eyelash length, 0.35 mm² (44.8 %) in thickness, and −12.02 intensity units (8 %) in darkness; vehicle parameters were essentially unchanged.
  • In study 2, month 4 improvements favored bimatoprost for eyelash length (2.65 vs 0.99 mm; P = 0.003), thickness (0.76 vs 0.28 mm²; P = 0.007), and darkness (−21.07 vs −4.60 intensity units; P = 0.040).
  • Adverse-event incidence was similar between groups in study 1 (41.4 vs 37.6 %; P = 0.643) and study 2 (66.7 vs 72.2 %; P > 0.999); ophthalmic exams showed small mean IOP reductions with bimatoprost that were within normal daily IOP fluctuation ranges.

Methods

  • Two multicenter, double-masked, randomized, parallel-group, vehicle-controlled studies of 5 months’ duration in Japan: study 1 enrolled 173 subjects with idiopathic eyelash hypotrichosis at eight centers; study 2 enrolled 36 subjects with chemotherapy-induced eyelash hypotrichosis at nine centers.
  • Subjects were ≥20 years old with GEA score 1 or 2, best-corrected visual acuity 20/100 or better per eye, and IOP ≤20 mmHg per eye; they applied bimatoprost 0.03 % or vehicle once nightly to upper eyelid margins for 4 months.
  • Primary efficacy analysis was intent-to-treat, with clinical response defined as ≥1-grade GEA improvement from baseline at month 4; between-group comparisons used Pearson’s Chi square or Fisher’s exact test, secondary DIA and ESQ-9 measures used Wilcoxon rank-sum tests, and missing efficacy data were imputed by last-observation-carried-forward up to month 4.

Limitations

  • The paper states that a limitation was the relatively short duration of the studies.
  • The paper states that study 2 was primarily a safety study, was not powered for efficacy, and enrolled a much smaller cohort.
  • Evident from the text: study 2 had only 36 subjects and all were women; study 1 was 89.6 % women, and both studies were limited to Japanese subjects, so generalizability to other populations or longer-term outcomes is not established by these data.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1007/s00266-014-0293-7

Cites

25 of 25 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

5 of 27 cited sources checked · 4 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    Bimatoprost 0.03% has enhanced eyelash prominence in clinical trials enrolling mostly Caucasian subjects.

    “Bimatoprost 0.03 % has enhanced eyelash prominence in clinical trials enrolling mostly Caucasian subjects.”
    • Also stated in: § Introduction · boosted
      “Bimatoprost 0.03 % solution has been shown in several clinical trials to enhance eyelash growth when applied topically to the upper eyelid margins [15–18].”
    Quote in the paperSubstantial claim1 of 4 sources checked
    • cites [15] Smith S, Fagien S, Whitcup SM, Ledon F, Somogyi C, Weng E, Beddingfield FC III (2012) Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol 66:801–806 source
    • cites [16] Wester ST, Lee WW, Shi W (2010) Eyelash growth from application of bimatoprost in gel suspension to the base of the eyelashes. Ophthalmology 117:1024–1031 source

      The Methods describe a randomized trial using bimatoprost 0.03% in a gel suspension, and the Results report significantly greater eyelash lengthening than with control gel. The Results identify the 19 participants as female but do not report their race or ethnicity, so the claim that subjects were mostly Caucasian is not supported by our copy. (LLM, conf=0.87)

      Experimental — accuracy not yet measured
    • cites [17] Woodward JA, Haggerty CJ, Stinnett SS, Williams ZY (2010) Bimatoprost 0.03 % gel for cosmetic eyelash growth and enhancement. J Cosmet Dermatol 9:96–102 source
    • cites [18] Yoelin S, Walt JG, Earl M (2010) Safety, effectiveness, and subjective experience with topical bimatoprost 0.03 % for eyelash growth. Dermatol Surg 36:638–649 source
  • Premisecitation

    The total dose of bimatoprost applied to the eyelid margins for eyelash hypotrichosis was approximately 5% of the dose compared with an eyedrop.

    “Although the same 0.03 % drug concentration was used for treatment of hypotrichosis of the eyelashes, the total dose applied to the eyelid margins was only approximately 5 % of the dose compared with an eyedrop [21].”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [21] Fagien S (2010) Management of hypotrichosis of the eyelashes: focus on bimatoprost. Clin Cosmet Investig Dermatol 3:39–48 source
  • Premisecitation

    The long-term safety of bimatoprost 0.03% for glaucoma and ocular hypertension has been established.

    “As noted earlier, the long-term safety of bimatoprost 0.03 % for glaucoma and ocular hypertension has been established.”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [11] Williams RD, Cohen JS, Gross RL, Liu CC, Safyan E, Batoosingh AL (2008) Long-term efficacy and safety of bimatoprost for intraocular pressure lowering in glaucoma and ocular hypertension: year 4. Br J Ophthalmol 92:1387–1392 source
    • cites [20] Wirta D, VanDenburgh AM, Weng E, Whitcup SM, Kurstjens S, Beddingfield FC III (2011) Long-term safety evaluation of bimatoprost ophthalmic solution 0.03 %: A pooled analysis of six double-masked, randomized, active-controlled clinical trials. Clin Ophthalmol 5:759–765 source
  • Findingown data

    In study 1, at month 4, in the bimatoprost group, improvements from baseline in ESQ-9 domain 1 were positively and significantly correlated with improvements in GEA score (ρ = 0.451; P < 0.001).

    “At month 4, for the bimatoprost group, the improvements from baseline in subject satisfaction with eyelashes, as measured by question 3 (ρ = 0.381), domain 1 (ρ = 0.451), and domain 2 (ρ = 0.409), were positively and significantly correlated with improvements from baseline in eyelash prominence, as measured by GEA score (all P < 0.001).”
    Quote in the paperNot a substantial claim
  • Findingown data

    In study 1, biomicroscopy and ophthalmoscopy findings of a one-grade increase from baseline were observed more frequently in the bimatoprost group, reflecting higher rates of conjunctival hyperemia (9.2 vs 0%; P = 0.007).

    “Biomicroscopy and ophthalmoscopy findings of a one-grade increase from baseline were observed more frequently in the bimatoprost group and reflected higher rates of conjunctival hyperemia (9.2 vs 0 %; P = 0.007).”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim. 12
  • May combine two claims. 20
  • The quote only partly states this claim. 3
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The effect of bimatoprost on eyelash growth is thought to arise by interaction with prostamide-sensitive receptors in hair follicles.

    “Eyelash growth was noted as an adverse effect of bimatoprost use in clinical trials of patients with glaucoma and ocular hypertension [9, 10, 12, 13], an effect thought to arise by the interaction of bimatoprost with prostamide-sensitive receptors in hair follicles [14].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [14] Woodward DF, Tang ES, Attar M, Wang JW (2013) The biodisposition and hypertrichotic effects of bimatoprost in mouse skin. Exp Dermatol 22:145–148 source
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The safety profile of bimatoprost 0.03% has been well established for treatment of open-angle glaucoma and ocular hypertension.

    “The safety profile of bimatoprost 0.03 % has been well established for treatment of open-angle glaucoma and ocular hypertension [11, 20].”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [11] Williams RD, Cohen JS, Gross RL, Liu CC, Safyan E, Batoosingh AL (2008) Long-term efficacy and safety of bimatoprost for intraocular pressure lowering in glaucoma and ocular hypertension: year 4. Br J Ophthalmol 92:1387–1392 source
    • cites [20] Wirta D, VanDenburgh AM, Weng E, Whitcup SM, Kurstjens S, Beddingfield FC III (2011) Long-term safety evaluation of bimatoprost ophthalmic solution 0.03 %: A pooled analysis of six double-masked, randomized, active-controlled clinical trials. Clin Ophthalmol 5:759–765 source
  • May combine two claims.

    Findingown data

    In study 2, visual acuity remained unchanged in most subjects, except for a decline of more than two lines in one subject and an increase of more than two lines in one subject, both in the bimatoprost group.

    “Visual acuity remained unchanged in most of the subjects, except for a decline of more than two lines in one subject and an increase of more than two lines in one subject, both in the bimatoprost group.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    In study 2, no subject had an intraocular pressure of 6 mmHg or lower, and no subject had an adverse event report of reduced intraocular pressure.

    “As in study 1, no subject had an IOP of 6 mmHg or lower, and no subject had an AE report of reduced IOP.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    In study 1, serious adverse events in the bimatoprost group included one case each of appendicitis and pyelonephritis, which were not considered associated with treatment.

    “The serious AEs in the bimatoprost group included one case each of appendicitis and pyelonephritis, which were not considered to be associated with treatment.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    In study 1, ophthalmic examination showed no statistically or clinically significant differences between the bimatoprost and vehicle groups in change from baseline in intraocular pressure at month 1 (−0.79 vs −0.47 mmHg; P = 0.264) or month 4 (−0.84 vs −0.23 mmHg; P = 0.085).

    “In study 1, ophthalmic examination showed no statistically or clinically significant differences between the bimatoprost and vehicle groups in terms of change from baseline in IOP (mean change from baseline to month 1, −0.79 vs −0.47 mmHg, P = 0.264; mean change from baseline to month 4, −0.84 vs −0.23 mmHg, P = 0.085).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    In study 1, the most common adverse events in the bimatoprost group were nasopharyngitis (13.8%), conjunctival hyperemia (4.6%), punctate keratitis (3.4%), eye discharge (3.4%), and skin hyperpigmentation (3.4%).

    “The most common AEs in the bimatoprost group were nasopharyngitis (13.8 %), conjunctival hyperemia (4.6 %), punctate keratitis (3.4 %), eye discharge (3.4 %), and skin hyperpigmentation (3.4 %).”
    Quote in the paperNot a substantial claim
  • The quote only partly states this claim.

    Findingown data

    In study 1, bimatoprost-treated subjects had significantly greater mean decrease (darkening) from baseline to month 4 in upper eyelash darkness than vehicle (−12.02 intensity units, 8%; P < 0.001).

    “In study 1, from baseline to month 4, the bimatoprost-treated subjects experienced mean improvements of 1.62 mm (24 %) in upper eyelash length, 0.35 mm2 (44.8 %) in upper eyelash thickness, and −12.02 intensity units (negative value represents darkening; 8 %) in upper eyelash darkness (Fig. 3).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    In study 1, visual acuity remained unchanged (between −2 and +2 lines) for more than 90% of patients at month 1 and more than 85% at month 4.

    “Visual acuity remained unchanged (between −2 and +2 lines) for more than 90 % of the patients in both groups (P = 0.248) at month 1 and for more than 85 % at month 4 (P = 0.257).”
    Quote in the paperSubstantial claim
  • The quote only partly states this claim.

    Findingown data

    In study 1, bimatoprost-treated subjects had significantly greater mean increase from baseline to month 4 in upper eyelash length than vehicle (1.62 mm, 24%; P < 0.001).

    “In study 1, from baseline to month 4, the bimatoprost-treated subjects experienced mean improvements of 1.62 mm (24 %) in upper eyelash length, 0.35 mm2 (44.8 %) in upper eyelash thickness, and −12.02 intensity units (negative value represents darkening; 8 %) in upper eyelash darkness (Fig. 3).”
    Quote in the paperSubstantial claim
  • The quote only partly states this claim.

    Findingown data

    In study 1, bimatoprost-treated subjects had significantly greater mean increase from baseline to month 4 in upper eyelash thickness than vehicle (0.35 mm2, 44.8%; P < 0.001).

    “In study 1, from baseline to month 4, the bimatoprost-treated subjects experienced mean improvements of 1.62 mm (24 %) in upper eyelash length, 0.35 mm2 (44.8 %) in upper eyelash thickness, and −12.02 intensity units (negative value represents darkening; 8 %) in upper eyelash darkness (Fig. 3).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    In study 1, significantly higher GEA response rates with bimatoprost were evident by month 1 and maintained at the month 5 posttreatment assessment.

    “In study 1, significantly higher response rates with bimatoprost, reflecting improved eyelash prominence, were evident by month 1 and maintained at the month 5 posttreatment assessment (Fig. 1).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    In study 1, no subject had an intraocular pressure of 6 mmHg or lower, and no subject had an adverse event report of reduced intraocular pressure.

    “No subject had an IOP of 6 mmHg or lower, and no subject had an AE report of reduced IOP.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    In study 2, no subjects in the bimatoprost group had serious adverse events, and no subjects discontinued the study due to adverse events.

    “No subjects in the bimatoprost group had serious AEs, and no subjects discontinued the study due to AEs.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationown data

    Bimatoprost 0.03% applied to upper eyelid margins once nightly for 4 months was effective and safe for Japanese subjects with hypotrichosis of the eyelashes, regardless of etiology.

    “These randomized clinical trials demonstrated that bimatoprost 0.03 % applied to upper eyelid margins once nightly for 4 months was effective and safe for Japanese subjects with hypotrichosis of the eyelashes, regardless of etiology.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Premisecitation

    The normal range for intraocular pressure is reportedly 7-21 mmHg, and daily fluctuations in intraocular pressure can show an approximate range of 3-7 mmHg.

    “The normal range for IOPs is reportedly 7–21 mmHg, and daily fluctuations in IOP can show an approximate range of 3–7 mmHg [22–25].”
    Quote in the paperSubstantial claim0 of 4 sources checked
    • cites [22] Martin XD (1992) Normal intraocular pressure in man. Ophthalmologica 205:57–63 source
    • cites [23] Murgatroyd H, Bembridge J (2008) Intraocular pressure. Cont Educ Anaesth Crit Care Pain 8:100–103 source
    • cites [24] David R, Zangwill L, Briscoe D, Dagan M, Yagev R, Yassur Y (1992) Diurnal intraocular pressure variations: an analysis of 690 diurnal curves. Br J Ophthalmol 76:280–283 source
    • cites [25] Fogagnolo P, Orzalesi N, Ferreras A, Rossetti L (2009) The circadian curve of intraocular pressure: can we estimate its characteristics during office hours? Invest Ophthalmol Vis Sci 50:2209–2215 source
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    A limitation of these studies was their relatively short duration.

    “A limitation of these studies was their relatively short duration.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Study design and conductnone given

    The primary efficacy end point was prospectively identified as clinical response, defined as at least a one-grade increase in GEA score from baseline at month 4.

    “The primary efficacy end point was prospectively identified as the clinical response and defined as at least a one-grade increase in GEA score from baseline at month 4.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    The studies were multicenter, double-masked, randomized, parallel-group, vehicle-controlled, and had a duration of 5 months.

    “The reported multicenter, double-masked, randomized, parallel-group, vehicle-controlled studies had a similar design and a duration of 5 months.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

    Study design and conductnone given

    The ESQ-9 has been translated, culturally adapted, and psychometrically validated with the Japanese population.

    “The ESQ-9 has been translated, culturally adapted, and psychometrically validated with the Japanese population.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Each study was performed in compliance with Japanese Good Clinical Practice, Good Clinical Practice, and International Conference on Harmonisation guidelines; institutional review board approval was obtained at each site; and all subjects gave written informed consent.

    “Each study was performed in compliance with Japanese Good Clinical Practice, Good Clinical Practice, and the International Conference on Harmonisation guidelines. Institutional review board approval was obtained at each site before initiation of the study, and all the subjects gave written informed consent.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Study design and conductown data

    Eyelash length, thickness, and darkness were measured using a validated digital image analysis of superior-view digital eyelash photographs taken with standardized equipment and subject positioning.

    “The secondary efficacy end points included measurements of upper eyelash length (mm), eyelash thickness (mm2), and eyelash darkness (intensity units) using a validated digital image analysis (DIA) of superior-view digital eyelash photographs taken with standardized equipment and subject positioning at each study visit (except for week 1).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Study design and conductown data

    Study 2 was primarily a safety study not powered for efficacy and enrolled a much smaller cohort.

    “Study 2 was primarily a safety study not powered for efficacy and enrolled a much smaller cohort.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Premisecitation

    In the North American study, statistically significant between-group differences in intraocular pressure were reported from week 1 through week 16, and by week 20 these differences had resolved.

    “Statistically significant between-group differences in IOP were reported in the North American study from week 1 through week 16. By the week 20 visit, these differences had resolved [15].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] Smith S, Fagien S, Whitcup SM, Ledon F, Somogyi C, Weng E, Beddingfield FC III (2012) Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol 66:801–806 source
  • Classified as probably not a substantial claim.

    Study design and conductown data

    All subjects in the studies were Japanese.

    “Note: GEA Global Eyelash Assessment All the subjects were Japanese”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationreasoning

    The changes in intraocular pressure observed in the current studies were well within normal ranges, consistent with low exposure to bimatoprost after topical application to the upper eyelid margins.

    “Accordingly, the changes observed in the current studies were well within normal ranges, consistent with the low exposure to bimatoprost after topical application to the upper eyelid margins.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim.

    Study design and conductnone given

    All efficacy analyses were conducted on the intent-to-treat population, which comprised all randomized subjects whether they had received study treatment or not.

    “All efficacy analyses were conducted on the intent-to-treat (ITT) population, which comprised all of the randomized subjects whether they had received study treatment or not.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationown data

    Bimatoprost 0.03% applied topically to the upper eyelid margins is effective in producing longer, thicker, darker, and more prominent eyelashes in Japanese subjects with hypotrichosis of the eyelashes, with a favorable safety profile supported by ophthalmic examination.

    “In summary, the current studies demonstrated that bimatoprost 0.03 % applied topically to the upper eyelid margins is effective in producing longer, thicker, darker, and more prominent eyelashes in Japanese subjects who have hypotrichosis of the eyelashes, with a favorable safety profile supported by ophthalmic examination.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationown data

    Ophthalmic examinations conducted at months 1 and 4 confirmed the safety of bimatoprost 0.03% for treatment of hypotrichosis of the eyelashes and indicated a good safety profile in Japanese subjects with hypotrichosis.

    “The ophthalmic examinations conducted at months 1 and 4 further confirmed the safety of bimatoprost 0.03 % for treatment of hypotrichosis of the eyelashes and indicated a good safety profile in Japanese subjects with hypotrichosis.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Study design and conductcitation

    Both the GEA and the GEA-J scales have been validated in previous clinical studies.

    “Both the GEA and the GEA-J scales have been validated in previous clinical studies [15].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] Smith S, Fagien S, Whitcup SM, Ledon F, Somogyi C, Weng E, Beddingfield FC III (2012) Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol 66:801–806 source
  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Eligible subjects were randomly assigned in a 1:1 ratio to bimatoprost 0.03% or vehicle by an interactive voice or Web response system on day 1 (baseline).

    “The eligible subjects were randomly assigned in a 1:1 ratio to bimatoprost 0.03 % or vehicle by an interactive voice or by a Web response system on day 1 (baseline).”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Safety parameters were evaluated in the safety population, which consisted of all subjects who received at least one dose of study medication.

    “Safety parameters were evaluated in the safety population, which consisted of all the subjects who received at least one dose of study medication.”
    Quote in the paperNot a substantial claim
32 of 32
  • The paper relies on this without support.

    Differences between Asian and Caucasian eyelash morphology may affect the efficacy or safety of bimatoprost for eyelash hypotrichosis, making evaluation in Japanese subjects necessary.

    “However, differences have been observed between Asian and Caucasian individuals in the number, thickness, and curliness of eyelashes [19]. Therefore, the two clinical trials described in this report aimed to evaluate the efficacy and safety of bimatoprost 0.03 % for Japanese subjects with hypotrichosis of the eyelashes.”
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Authors
Harii, K., Arase, S., Tsuboi, R., Weng, E., Daniels, S., & VanDenburgh, A.
Affiliations
  • Kyorin University (JP)
  • Naruto, Tokushima Prefecture hospital (JP)
  • Tokyo Medical University (JP)
  • Allergan (United States) (US)
Corresponding author
VanDenburgh, A.
Venue
Aesthetic Plastic Surgery
Published
2014-03-19
Volume
38
Issue
2
Pages
451-460
ISSN
  • 0364-216X (ISSN-L)
  • 1432-5241
OpenAlex
W2014721020
Cited by
29
References
25
Citations by year
2026: 1 · 2025: 4 · 2024: 4 · 2023: 2 · 2022: 3 · 2021: 2 · 2018: 1 · 2017: 5 · 2016: 3 · 2015: 3 · 2014: 1
FWCI
4.53
Type
journal article
Language
en
Open access
Locations
  • Aesthetic Plastic Surgery (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (submittedVersion)
  • PubMed Central (submittedVersion, cc-by)
Funders
Allergan
Topics
  • Health Sciences › Medicine › Urology › Hair Growth and Disorders
  • Health Sciences › Medicine › Dermatology › Chemotherapy-related skin toxicity
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ocular Surface and Contact Lens
Keywords
bimatoprost, eyelash growth, intraocular pressure, adverse events, Japanese subjects
MeSH terms
Bimatoprost, Adult, Amides, Cloprostenol, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Esthetics, Eyelashes, Female, Follow-Up Studies, Humans, Middle Aged, Ophthalmic Solutions, Reference Values, Chi-Square Distribution, Treatment Outcome, Patient Satisfaction, Risk Assessment, Statistics, Nonparametric, Asian People

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