drugset / Trial / NCT05456087
Use of Botulinum Toxin in the Treatment of Androgenic Alopecia
Phase 2
Active not recruiting
20 enrolled
Zel Skin and Laser Specialists
Merz Aesthetics Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the effect of using a purified botulinum toxin (Xeomin®, Merz, USA), the same injectable used to improve face wrinkles, to treat a specific type of hair loss seen in men and women not associated with scarring or other internal disease called 'pattern hair loss'. This type of hair loss is medically called 'androgenic or androgenetic alopecia'. In men it is typically called 'male pattern baldness' whereas in women it is called 'female pattern baldness' and in both cases is hereditary meaning there will be a history of relatives that describe having the same condition.
Timeline
- Start
- 2022-08-12
- Primary completion
- 2024-12
- Completion
- 2024-12
Publications
- Background Russo PM, Fino E, Mancini C, Mazzetti M, Starace M, Piraccini BM. HrQoL in hair loss-affected patients with alopecia areata, androgenetic alopecia and telogen effluvium: the role of personality traits and psychosocial anxiety. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):608-611. doi: 10.1111/jdv.15327. Epub 2018 Dec 2.
- Background Cash TF. The psychosocial consequences of androgenetic alopecia: a review of the research literature. Br J Dermatol. 1999 Sep;141(3):398-405. doi: 10.1046/j.1365-2133.1999.03030.x.
- Background Bienova M, Kucerova R, Fiuraskova M, Hajduch M, Kolar Z. Androgenetic alopecia and current methods of treatment. Acta Dermatovenerol Alp Pannonica Adriat. 2005 Mar;14(1):5-8.
- Background Norwood OT. Incidence of female androgenetic alopecia (female pattern alopecia). Dermatol Surg. 2001 Jan;27(1):53-4.
- Background Starace M, Orlando G, Alessandrini A, Piraccini BM. Female Androgenetic Alopecia: An Update on Diagnosis and Management. Am J Clin Dermatol. 2020 Feb;21(1):69-84. doi: 10.1007/s40257-019-00479-x.
- Background Inui S, Itami S. Androgen actions on the human hair follicle: perspectives. Exp Dermatol. 2013 Mar;22(3):168-71. doi: 10.1111/exd.12024. Epub 2012 Sep 28.
- Background Ramos PM, Miot HA. Female Pattern Hair Loss: a clinical and pathophysiological review. An Bras Dermatol. 2015 Jul-Aug;90(4):529-43. doi: 10.1590/abd1806-4841.20153370.
- Background Cousen P, Messenger A. Female pattern hair loss in complete androgen insensitivity syndrome. Br J Dermatol. 2010 May;162(5):1135-7. doi: 10.1111/j.1365-2133.2010.09661.x. Epub 2010 Feb 1.
- Background Sinclair R. Winding the clock back on female androgenetic alopecia. Br J Dermatol. 2012 Jun;166(6):1157-8. doi: 10.1111/j.1365-2133.2012.10934.x. No abstract available.
- Background Cotsarelis G, Millar SE. Towards a molecular understanding of hair loss and its treatment. Trends Mol Med. 2001 Jul;7(7):293-301. doi: 10.1016/s1471-4914(01)02027-5.
- Background Goldman BE, Fisher DM, Ringler SL. Transcutaneous PO2 of the scalp in male pattern baldness: a new piece to the puzzle. Plast Reconstr Surg. 1996 May;97(6):1109-16; discussion 1117. doi: 10.1097/00006534-199605000-00003.
- Background Ramos PM, Brianezi G, Martins AC, da Silva MG, Marques ME, Miot HA. Apoptosis in follicles of individuals with female pattern hair loss is associated with perifollicular microinflammation. Int J Cosmet Sci. 2016 Dec;38(6):651-654. doi: 10.1111/ics.12341. Epub 2016 Jun 1.
- Background Garza LA, Liu Y, Yang Z, Alagesan B, Lawson JA, Norberg SM, Loy DE, Zhao T, Blatt HB, Stanton DC, Carrasco L, Ahluwalia G, Fischer SM, FitzGerald GA, Cotsarelis G. Prostaglandin D2 inhibits hair growth and is elevated in bald scalp of men with androgenetic alopecia. Sci Transl Med. 2012 Mar 21;4(126):126ra34. doi: 10.1126/scitranslmed.3003122.
- Background Jaworsky C, Kligman AM, Murphy GF. Characterization of inflammatory infiltrates in male pattern alopecia: implications for pathogenesis. Br J Dermatol. 1992 Sep;127(3):239-46. doi: 10.1111/j.1365-2133.1992.tb00121.x.
- Background Gupta M, Mysore V. Classifications of Patterned Hair Loss: A Review. J Cutan Aesthet Surg. 2016 Jan-Mar;9(1):3-12. doi: 10.4103/0974-2077.178536.
- Background HAMILTON JB. Patterned loss of hair in man; types and incidence. Ann N Y Acad Sci. 1951 Mar;53(3):708-28. doi: 10.1111/j.1749-6632.1951.tb31971.x. No abstract available.
- Background Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009.
- Background Ludwig E. Classification of the types of androgenetic alopecia (common baldness) occurring in the female sex. Br J Dermatol. 1977 Sep;97(3):247-54. doi: 10.1111/j.1365-2133.1977.tb15179.x.
- Background Olsen EA. The midline part: an important physical clue to the clinical diagnosis of androgenetic alopecia in women. J Am Acad Dermatol. 1999 Jan;40(1):106-9. doi: 10.1016/s0190-9622(99)70539-6. No abstract available.
- Background Kasprzak M, Sicinska J, Sinclair R. The Trichoscopy Derived Sinclair Scale: Enhancing visual assessment through quantitative trichoscopy. Australas J Dermatol. 2019 May;60(2):134-136. doi: 10.1111/ajd.12964. Epub 2018 Dec 18.
- Background Sinclair R, Jolley D, Mallari R, Magee J. The reliability of horizontally sectioned scalp biopsies in the diagnosis of chronic diffuse telogen hair loss in women. J Am Acad Dermatol. 2004 Aug;51(2):189-99. doi: 10.1016/s0190-9622(03)00045-8.
- Background Dinh QQ, Sinclair R. Female pattern hair loss: current treatment concepts. Clin Interv Aging. 2007;2(2):189-99.
- Background Afifi L, Maranda EL, Zarei M, Delcanto GM, Falto-Aizpurua L, Kluijfhout WP, Jimenez JJ. Low-level laser therapy as a treatment for androgenetic alopecia. Lasers Surg Med. 2017 Jan;49(1):27-39. doi: 10.1002/lsm.22512. Epub 2016 Apr 25.
- Background Jimenez JJ, Wikramanayake TC, Bergfeld W, Hordinsky M, Hickman JG, Hamblin MR, Schachner LA. Efficacy and safety of a low-level laser device in the treatment of male and female pattern hair loss: a multicenter, randomized, sham device-controlled, double-blind study. Am J Clin Dermatol. 2014 Apr;15(2):115-27. doi: 10.1007/s40257-013-0060-6.
- Background Starace M, Alessandrini A, D'Acunto C, Melandri D, Bruni F, Patrizi A, Piraccini BM. Platelet-rich plasma on female androgenetic alopecia: Tested on 10 patients. J Cosmet Dermatol. 2019 Feb;18(1):59-64. doi: 10.1111/jocd.12550. Epub 2018 Apr 30.
- Background Giordano S, Romeo M, di Summa P, Salval A, Lankinen P. A Meta-analysis On Evidence Of Platelet-rich Plasma for Androgenetic Alopecia. Int J Trichology. 2018 Jan-Feb;10(1):1-10. doi: 10.4103/ijt.ijt_74_16.
- Background Singh S, Neema S, Vasudevan B. A Pilot Study to Evaluate Effectiveness of Botulinum Toxin in Treatment of Androgenetic Alopecia in Males. J Cutan Aesthet Surg. 2017 Jul-Sep;10(3):163-167. doi: 10.4103/JCAS.JCAS_77_17.
- Background Zhou Y, Yu S, Zhao J, Feng X, Zhang M, Zhao Z. Effectiveness and Safety of Botulinum Toxin Type A in the Treatment of Androgenetic Alopecia. Biomed Res Int. 2020 Aug 4;2020:1501893. doi: 10.1155/2020/1501893. eCollection 2020.
- Background Melo DF, Ramos PM, Antelo DAP, Machado CJ, Barcaui CB. Is there a rationale for the use of botulinum toxin in the treatment of Androgenetic Alopecia? J Cosmet Dermatol. 2021 Jul;20(7):2093-2095. doi: 10.1111/jocd.14177. Epub 2021 May 3. No abstract available.
- Background Zhang L, Yu Q, Wang Y, Ma Y, Shi Y, Li X. A small dose of botulinum toxin A is effective for treating androgenetic alopecia in Chinese patients. Dermatol Ther. 2019 Jul;32(4):e12785. doi: 10.1111/dth.12785. Epub 2019 Jan 8. No abstract available.
- Background Unger WP, Unger RH. Hair transplanting: an important but often forgotten treatment for female pattern hair loss. J Am Acad Dermatol. 2003 Nov;49(5):853-60. doi: 10.1016/s0190-9622(03)01568-8.
- Background Kanti V, Messenger A, Dobos G, Reygagne P, Finner A, Blumeyer A, Trakatelli M, Tosti A, Del Marmol V, Piraccini BM, Nast A, Blume-Peytavi U. Evidence-based (S3) guideline for the treatment of androgenetic alopecia in women and in men - short version. J Eur Acad Dermatol Venereol. 2018 Jan;32(1):11-22. doi: 10.1111/jdv.14624. Epub 2017 Nov 27.
- Background Witmanowski H, Blochowiak K. The whole truth about botulinum toxin - a review. Postepy Dermatol Alergol. 2020 Dec;37(6):853-861. doi: 10.5114/ada.2019.82795. Epub 2019 Feb 5.
- Background Martina E, Diotallevi F, Radi G, Campanati A, Offidani A. Therapeutic Use of Botulinum Neurotoxins in Dermatology: Systematic Review. Toxins (Basel). 2021 Feb 5;13(2):120. doi: 10.3390/toxins13020120.
- Background Rakowska A, Slowinska M, Kowalska-Oledzka E, Olszewska M, Rudnicka L. Dermoscopy in female androgenic alopecia: method standardization and diagnostic criteria. Int J Trichology. 2009 Jul;1(2):123-30. doi: 10.4103/0974-7753.58555.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 150 iu | Other |