drugset / Trial / NCT05008887
Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus 5-fluorouracil in Stable Non-segmental Vitiligo
RandomizedParallel-groupOpen-labelTreatment
Summary
Vitiligo is a common acquired, depigmenting skin disease that affect the patient's psychological state and quality of life.
Timeline
- Start
- 2022-09
- Primary completion
- 2023-03
- Completion
- 2023-04
Publications
- Background Lai YC, Yew YW, Kennedy C, Schwartz RA. Vitiligo and depression: a systematic review and meta-analysis of observational studies. Br J Dermatol. 2017 Sep;177(3):708-718. doi: 10.1111/bjd.15199. Epub 2017 Jul 23.
- Background Agarwal K, Podder I, Kassir M, Vojvodic A, Schwartz RA, Wollina U, Valle Y, Lotti T, Rokni GR, Grabbe S, Goldust M. Therapeutic options in vitiligo with special emphasis on immunomodulators: A comprehensive update with review of literature. Dermatol Ther. 2020 Mar;33(2):e13215. doi: 10.1111/dth.13215. Epub 2020 Jan 12.
- Background Kim HJ, Hong ES, Cho SH, Lee JD, Kim HS. Fractional Carbon Dioxide Laser as an "Add-on" Treatment for Vitiligo: A Meta-analysis with Systematic Review. Acta Derm Venereol. 2018 Feb 7;98(2):180-184. doi: 10.2340/00015555-2836.
- Background Shin J, Lee JS, Hann SK, Oh SH. Combination treatment by 10 600 nm ablative fractional carbon dioxide laser and narrowband ultraviolet B in refractory nonsegmental vitiligo: a prospective, randomized half-body comparative study. Br J Dermatol. 2012 Mar;166(3):658-61. doi: 10.1111/j.1365-2133.2011.10723.x. Epub 2012 Jan 19.
- Background Abdelmaksoud A, Dave DD, Lotti T, Vestita M. Topical methotrexate 1% gel for treatment of vitiligo: A case report and review of the literature. Dermatol Ther. 2019 Sep;32(5):e13013. doi: 10.1111/dth.13013. Epub 2019 Jul 16.
- Background Aickara D, Bashyam AM, Pichardo RO, Feldman SR. Topical methotrexate in dermatology: a review of the literature. J Dermatolog Treat. 2022 Feb;33(1):512-517. doi: 10.1080/09546634.2020.1770170. Epub 2020 May 25.
- Background Taudorf EH, Lerche CM, Vissing AC, Philipsen PA, Hannibal J, D'Alvise J, Hansen SH, Janfelt C, Paasch U, Anderson RR, Haedersdal M. Topically applied methotrexate is rapidly delivered into skin by fractional laser ablation. Expert Opin Drug Deliv. 2015 Jul;12(7):1059-69. doi: 10.1517/17425247.2015.1031216. Epub 2015 Apr 20.
- Background Doghaim NN, El-Tatawy RA, Ismail MA, Ali DAM, El Attar YA. Study the effect of erbium:YAG laser plus topical 5-flurouracil in stable vitiligo resistant to NB-UVB phototherapy. J Cosmet Dermatol. 2020 Jan;19(1):122-130. doi: 10.1111/jocd.13134. Epub 2019 Oct 1.
- Background Anbar TS, Westerhof W, Abdel-Rahman AT, Ewis AA, El-Khayyat MA. Effect of one session of ER:YAG laser ablation plus topical 5Fluorouracil on the outcome of short-term NB-UVB phototherapy in the treatment of non-segmental vitiligo: a left-right comparative study. Photodermatol Photoimmunol Photomed. 2008 Dec;24(6):322-9. doi: 10.1111/j.1600-0781.2008.00385.x.
- Background Vaccaro M, Cannavo SP, Imbesi S, Cristani M, Barbuzza O, Tigano V, Gangemi S. Increased serum levels of interleukin-23 circulating in patients with non-segmental generalized vitiligo. Int J Dermatol. 2015 Jun;54(6):672-4. doi: 10.1111/ijd.12392. Epub 2014 Nov 27.
- Background Kadry M, Tawfik A, Abdallah N, Badawi A, Shokeir H. Platelet-rich plasma versus combined fractional carbon dioxide laser with platelet-rich plasma in the treatment of vitiligo: a comparative study. Clin Cosmet Investig Dermatol. 2018 Nov 8;11:551-559. doi: 10.2147/CCID.S178817. eCollection 2018.
- Ismail SA, Sayed AM, Elkabsh MM, Rayan AA, Mekkawy MM. Methotrexate Cutaneous Delivery by Fractional CO2 Laser Against 5-Fluorouracil in Stable, Nonsegmental Vitiligo. Dermatol Surg. 2026 Jun 22. doi: 10.1097/DSS.0000000000005222. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 2.5 % | Topical |
| Comparator | fluorouracil | Small molecule | 5 % | Topical |