An evaluation of the safety and efficacy of bimatoprost for eyelash growth in pediatric subjects

Mark Borchert, Suzanne Bruce, David Wirta, Steven G Yoelin, Sungwook Lee, Cheri Mao, Amanda VanDenburgh, Mark Borchert, Suzanne Bruce, David Wirta, Steven G Yoelin, Sungwook Lee, Cheri Mao, Amanda VanDenburgh

Abstract

Purpose: Evaluate the safety and effectiveness of bimatoprost 0.03% for treatment of eyelash hypotrichosis in a pediatric population.

Patients and methods: This multicenter, randomized, double-masked, parallel-group study was conducted at seven sites in the US and Brazil. Subjects with eyelash hypotrichosis caused by chemotherapy or alopecia areata (aged 5-17 years) or healthy adolescents aged 15-17 years were enrolled (N=71). Subjects applied bimatoprost 0.03% or vehicle to upper eyelid margins once nightly for 4 months and were followed for 1 month post-treatment. Eyelash prominence was assessed using the validated 4-grade Global Eyelash Assessment scale with photonumeric guide. Changes in eyelash length, thickness, and darkness were measured by digital image analysis. Safety was assessed by adverse events and ophthalmic observations.

Results: Eyelash prominence improved in a significantly greater proportion of subjects treated with bimatoprost compared with vehicle at month 4 (70.8% versus 26.1%; P<0.001). This benefit was sustained at month 5 post-treatment assessment. Digital image analysis measures were significantly improved with bimatoprost. Significant treatment benefits with bimatoprost versus vehicle were evident among the healthy adolescents but not in the postchemotherapy or alopecia areata subgroups. The safety profile of bimatoprost was consistent with previous studies in adults.

Conclusion: Bimatoprost was safe and well tolerated in pediatric subjects with eyelash hypotrichosis. In this study with limited sample size, subgroup analyses showed that treatment was effective in healthy adolescents with no concurrent contributing medical condition, but not in those with eyelash hypotrichosis due to chemotherapy or alopecia areata.

Keywords: Latisse; adolescent; child; hypotrichosis.

Figures

Figure 1
Figure 1
Percentage of pediatric subjects with at least a 1-grade improvement from baseline in Global Eyelash Assessment scores. Notes: (A) Overall population. (B) Healthy adolescents. (C) Postchemotherapy pediatric subjects. (D) Pediatric subjects with alopecia areata. Study treatment was applied once nightly for 4 months. Subjects did not use study treatment between months 4 and 5. *P=0.004 versus vehicle. **P<0.001 versus vehicle.
Figure 2
Figure 2
Examples of response to bimatoprost treatment with a 1-grade improvement in GEA score from baseline to month 4. Notes: In a healthy subject aged 17 years, GEA score at baseline was 3 (A) and improved to GEA score of 4 at month 4 (B). In a postchemotherapy subject aged 13 years, baseline GEA score of 2 (C) improved to GEA score of 3 at month 4 (D). Abbreviation: GEA, Global Eyelash Assessment.
Figure 3
Figure 3
Responses to the ESQ-3 at month 4 for (A) satisfaction with eyelash length, (B) satisfaction with eyelash fullness/thickness, and (C) overall eyelash satisfaction for the overall pediatric population aged 12–17 years. Notes: Study treatment was applied once nightly for 4 months; subjects did not use study treatment between months 4 and 5. Abbreviation: ESQ-3, 3-item Eyelash Satisfaction Questionnaire.

References

    1. Law SK. Bimatoprost in the treatment of eyelash hypotrichosis. Clin Ophthalmol. 2010;4:349–358.
    1. Kutner A, Friedman A. Hair loss in the dermatology office: an update on alopecia areata. J Drugs Dermatol. 2013;12:588–593.
    1. Paus R, Haslam IS, Sharov AA, Botchkarev VA. Pathobiology of chemotherapy-induced hair loss. Lancet Oncol. 2013;14:e50–e59.
    1. Draelos ZD. Special considerations in eye cosmetics. Clin Dermatol. 2001;19:424–430.
    1. American Academy of Ophthalmology . American Academy of Ophthalmology warns consumers about the dangers of eyelash extensions [press release] San Francisco, CA: American Academy of Ophthalmology; [Accessed December 18, 2015]. Available from:
    1. Cohen JL. Enhancing the growth of natural eyelashes: the mechanism of bimatoprost-induced eyelash growth. Dermatol Surg. 2010;36:1361–1371.
    1. Higginbotham EJ, Schuman JS, Goldberg I, et al. One-year, randomized study comparing bimatoprost and timolol in glaucoma and ocular hypertension. Arch Ophthalmol. 2002;120:1286–1293.
    1. Whitcup SM, Cantor LB, VanDenburgh AM, Chen K. A randomised, double masked, multicentre clinical trial comparing bimatoprost and timolol for the treatment of glaucoma and ocular hypertension. Br J Ophthalmol. 2003;87:57–62.
    1. Williams RD, Cohen JS, Gross RL, Liu CC, Safyan E, Batoosingh AL. Long-term efficacy and safety of bimatoprost for intraocular pressure lowering in glaucoma and ocular hypertension: year 4. Br J Ophthalmol. 2008;92:1387–1392.
    1. Fagien S. Management of hypotrichosis of the eyelashes: focus on bimatoprost. Clin Cosmet Investig Dermatol. 2010;3:39–48.
    1. Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014;38:451–460.
    1. Smith S, Fagien S, Whitcup SM, et al. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol. 2012;66:801–806.
    1. Wirta D, VanDenburgh AM, Weng E, Whitcup SM, Kurstjens S, Beddingfield FC., III Long-term safety evaluation of bimatoprost ophthalmic solution 0.03%: a pooled analysis of six double-masked, randomized, active-controlled clinical trials. Clin Ophthalmol. 2011;5:759–765.
    1. David R, Zangwill L, Briscoe D, Dagan M, Yagev R, Yassur Y. Diurnal intraocular pressure variations: an analysis of 690 diurnal curves. Br J Ophthalmol. 1992;76:280–283.
    1. Morris CL, Stinnett S, Woodward J. The role of bimatoprost eyelash gel in chemotherapy-induced madarosis: an analysis of efficacy and safety. Int J Trichology. 2011;3:84–91.
    1. Ahluwalia GS. Safety and efficacy of bimatoprost solution 0.03% topical application in patients with chemotherapy-induced eyelash loss. J Investig Dermatol Symp Proc. 2013;16:S73–S76.
    1. Ochoa BE, Sah D, Wang G, Stamper R, Price VH. Instilled bimatoprost ophthalmic solution in patients with eyelash alopecia areata. J Am Acad Dermatol. 2009;61:530–532.
    1. Roseborough I, Lee H, Chwalek J, Stamper RL, Price VH. Lack of efficacy of topical latanoprost and bimatoprost ophthalmic solutions in promoting eyelash growth in patients with alopecia areata. J Am Acad Dermatol. 2009;60:705–706.
    1. Vila TO, Camacho Martinez FM. Bimatoprost in the treatment of eyelash universalis alopecia areata. Int J Trichology. 2010;2:86–88.
    1. Zaheri S, Hughes B. Successful use of bimatoprost in the treatment of alopecia of the eyelashes. Clin Exp Dermatol. 2010;35:e161–e162.
    1. Smith JA. The impact of skin disease on the quality of life of adolescents. Adolesc Med. 2001;12(2):vii, 343–353.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa