drugset / Trial / NCT05083286
Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a blinded, randomized study in the US to compare the duration response of two different concentrations of BOTOX in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.
Timeline
- Start
- 2021-10-20
- Primary completion
- 2022-08-01
- Completion
- 2022-08-01
Publications
- Background Blitzer A, Binder WJ, Aviv JE, Keen MS, Brin MF. The management of hyperfunctional facial lines with botulinum toxin. A collaborative study of 210 injection sites in 162 patients. Arch Otolaryngol Head Neck Surg. 1997 Apr;123(4):389-92. doi: 10.1001/archoto.123.4.389.
- Background Carruthers A, Carruthers J, Said S. Dose-ranging study of botulinum toxin type A in the treatment of glabellar rhytids in females. Dermatol Surg. 2005 Apr;31(4):414-22; discussion 422. doi: 10.1111/j.1524-4725.2005.31107.
- Background Carruthers JA, Lowe NJ, Menter MA, Gibson J, Nordquist M, Mordaunt J, Walker P, Eadie N; BOTOX Glabellar Lines I Study Group. A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2002 Jun;46(6):840-9. doi: 10.1067/mjd.2002.121356.
- Background Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 20 iu | — |
Indications
No indication recorded.