Comparative Study Between Topical 5-fluorouracil and Latanoprost in Vitiligo.
NCT ID: NCT05513924
Last Updated: 2023-07-11
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2022-03-15
2022-12-01
Brief Summary
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Detailed Description
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Theories regarding loss of melanocytes are based on autoimmune, cytotoxic, oxidant-antioxidant and neural mechanisms.
Therapeutic strategies for vitiligo include nonsurgical and surgical methods. Nonsurgical options include topical corticosteroids and topical calcineurin inhibitors. Phototherapy as psoralen and ultraviolet A (PUVA) and narrow-band ultraviolet B (NB-UVB).
Two types of surgical techniques are available: tissue grafts and cellular grafts, within between autologous cultured epithelial grafts.
Microneedling is a method of transdermal drug delivery using a microneedling device applied to the skin for creating transport pathways through the stratum corneum, increasing the absorption of drugs and decreasing the duration of therapy. In addition, microneedling keeps the epidermis partially intact, fastens recovery, and limits the risk of infection and scarring. 5-Fluorouracil (5-FU) is a chemotherapeutic agent used in the treatment of many malignant tumors and it has been approved for topical use in the treatment of several dermatologic disorders. Localized hyperpigmentation occurred as a side effect of 5-FU use in cancer treatment attracts the attention toward its application in inducing repigmentation in vitiligo patches.
Latanoprost (LT), a prostaglandin F2 alpha analogue used in the treatment of glaucoma, was found to induce skin pigmentation in guinea pigs in addition to its known periocular and iridal pigmentation side effect.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A (topical latanoprost)
20 vitiligo patients will receive topical latanoprost solution (the concentration of the solution is 0.005%, pharmaceutically available eye-drop formulation)
Latanoprost 0.005% Ophthalmic Solution
The affected area cleaned with betadine surgical solution followed by alcohol 70%.
Local anesthetic, pridocaine cream, applied on the treated area under occlusion for 30 min before the procedure.
Using automated microneedling device (Dr Pen Derma Pen Ultima A6®) , which has a disposable head that personalized for each patient and sterilized after each session.
The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern until pinpoint bleeding appears.
The LT solution will be applied immediately to vitiligo patch one drop (contains 1.5 μg of LT) for every 2.5 cm.
This procedure will be repeated every two weeks for six months.
Group B (topical 5-fluorouracil)
20 vitiligo patients will receive topical 5-fluorouracil 5% solution available as ampoules (Utoral®, EIMC United Pharmaceuticals, Egypt)
5Fluorouracil
The affected area cleaned with betadine surgical solution followed by alcohol 70%.
Local anesthetic, pridocaine cream, applied on the treated area under occlusion for 30 min before the procedure.
Using automated microneedling device (Dr Pen Derma Pen Ultima A6®) , which has a disposable head that personalized for each patient and sterilized after each session.
The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern until pinpoint bleeding appears.
Topical application of 5-fluorouracil 5% solution will be rubbed over the affected area for about 2 minutes. Occlusive dressing for hours.
This procedure will be repeated every two weeks for six months.
Interventions
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Latanoprost 0.005% Ophthalmic Solution
The affected area cleaned with betadine surgical solution followed by alcohol 70%.
Local anesthetic, pridocaine cream, applied on the treated area under occlusion for 30 min before the procedure.
Using automated microneedling device (Dr Pen Derma Pen Ultima A6®) , which has a disposable head that personalized for each patient and sterilized after each session.
The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern until pinpoint bleeding appears.
The LT solution will be applied immediately to vitiligo patch one drop (contains 1.5 μg of LT) for every 2.5 cm.
This procedure will be repeated every two weeks for six months.
5Fluorouracil
The affected area cleaned with betadine surgical solution followed by alcohol 70%.
Local anesthetic, pridocaine cream, applied on the treated area under occlusion for 30 min before the procedure.
Using automated microneedling device (Dr Pen Derma Pen Ultima A6®) , which has a disposable head that personalized for each patient and sterilized after each session.
The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern until pinpoint bleeding appears.
Topical application of 5-fluorouracil 5% solution will be rubbed over the affected area for about 2 minutes. Occlusive dressing for hours.
This procedure will be repeated every two weeks for six months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Active Koebner's phenomenon.
* Age less than 10 years.
* All patients included had not received any local or systemic medication for at least 2 months before the study.
* Keloidal tendency.
10 Years
60 Years
ALL
No
Sponsors
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South Valley University
OTHER
Responsible Party
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Amal Mohamed Abdelaziz Ashour
Principal Investigator
Principal Investigators
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Hassan M Ibrahim, professor
Role: STUDY_CHAIR
South Valley University
Locations
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South Valley University
Qina, Qena Governorate, Egypt
Countries
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References
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Bacigalupi RM, Postolova A, Davis RS. Evidence-based, non-surgical treatments for vitiligo: a review. Am J Clin Dermatol. 2012 Aug 1;13(4):217-37. doi: 10.2165/11630540-000000000-00000.
Laddha NC, Dwivedi M, Mansuri MS, Gani AR, Ansarullah M, Ramachandran AV, Dalai S, Begum R. Vitiligo: interplay between oxidative stress and immune system. Exp Dermatol. 2013 Apr;22(4):245-50. doi: 10.1111/exd.12103. Epub 2013 Feb 21.
van Geel N, Ongenae K, Naeyaert JM. Surgical techniques for vitiligo: a review. Dermatology. 2001;202(2):162-6. doi: 10.1159/000051626.
Prausnitz MR. Microneedles for transdermal drug delivery. Adv Drug Deliv Rev. 2004 Mar 27;56(5):581-7. doi: 10.1016/j.addr.2003.10.023.
Prince GT, Cameron MC, Fathi R, Alkousakis T. Topical 5-fluorouracil in dermatologic disease. Int J Dermatol. 2018 Oct;57(10):1259-1264. doi: 10.1111/ijd.14106. Epub 2018 Jun 25.
Mohamed HA, Mohammed GF, Gomaa AH, Eyada MM. Carbon dioxide laser plus topical 5-fluorouracil: a new combination therapeutic modality for acral vitiligo. J Cosmet Laser Ther. 2015;17(4):216-23. doi: 10.3109/14764172.2014.1003241. Epub 2015 Jan 30.
Anbar TS, El-Ammawi TS, Abdel-Rahman AT, Hanna MR. The effect of latanoprost on vitiligo: a preliminary comparative study. Int J Dermatol. 2015;54(5):587-93. doi: 10.1111/ijd.12631. Epub 2014 Dec 29.
Nugroho H, Fadzil MH, Yap VV, Norashikin S, Suraiya HH. Determination of skin repigmentation progression. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:3442-5. doi: 10.1109/IEMBS.2007.4353071.
Other Identifiers
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370
Identifier Type: -
Identifier Source: org_study_id
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