Effect Of Topical Prostaglandin F2α Analogs,Fractional CO2 Laser, Excimer Laser Or Their Combination In Treatment Of Vitiligo
Safety And Efficacy Of Topical Prostaglandin F2α Analogs In Combination With Fractional CO2 Laser And 308 Excimer Light In Treatment Of Vitiligo
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
Vitiligo is a chronic disease with an unpredictable clinical course, characterized by the appearance of white macules and patches on the skin and mucous membranes due to the disappearance of melanocytes in the affected area. It affects approximately 0.5% - 2% of the population worldwide and may occur at any age. Vitiligo is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 6, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedOctober 22, 2020
September 1, 2020
1 year
September 26, 2020
October 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
clinical improvement through VASI score
VASI score will be calculated for each patient at start, every 4 weeks and 6 months after the last session. VASI = ∑ all treated sites \[number of hand units\] X \[% residual depigmentation\].
9 months
Secondary Outcomes (3)
Patients satisfaction
9 months
percent of repigmentation
9 months
Histopathological evaluation
9 months
Study Arms (1)
vitiligo patients
EXPERIMENTALThirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
Interventions
30 Patches treated with Topical Travoprost 0.004% solution: Topical travoprost 0.004% solution once daily (1 drop for each 2.5 x 2.5 cm2) for 3 months.
30 Patches treated with Fractional CO2 laser: Fractional CO2 laser sessions twice monthly for 3 months, parameters settings as follows: Energy\\ dot 100mj, pulse duration 5ms, density level 17, pattern: array, depth level 1, 2 passes used
30 Patches treated with Excimer laser: Excimer laser sessions will be repeated twice weekly on the selected patch only, The starting dose will be 200 mj /cm2, an increase of 100 mJ/cm2 in the following session if no erythema appears, an increase of 50 mJ/cm2 every session till the appearance of erythema that lasts 24 hours or more.
30 Patches treated with Combination therapy: Fractional CO2 laser twice per month followed by application of topical travoprost 0,004% daily and excimer laser twice weekly .
30 Patches treated with Excimer laser twice weekly and topical travoprost once daily for 3 months
30 Patches treated with fractional CO2 laser twice monthly and topical travoprost once daily for 3 months
Eligibility Criteria
You may qualify if:
- Patients older than 12 years.
- Patients with generalized non-segmental vitiligo.
- No previous treatment for vitiligo in the last 1 month.
- Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.
You may not qualify if:
- Patients with sensitivity to travoprost.
- Patients with photosensitivity.
- Patients with history or active skin cancer.
- No other dermatological or systemic diseases.
- Active infections .
- Pregnant or lactating females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Fa Y, Lin Y, Chi XJ, Shi WH, Wang JL, Guo X, Geng JH, Liu HX, Zhang FR. Treatment of vitiligo with 308-nm excimer laser: our experience from a 2-year follow-up of 979 Chinese patients. J Eur Acad Dermatol Venereol. 2017 Feb;31(2):337-340. doi: 10.1111/jdv.13917. Epub 2016 Sep 19.
PMID: 27538097BACKGROUNDKim 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.
PMID: 29110015BACKGROUNDKhattab FM, Abdelbary E, Fawzi M. Evaluation of combined excimer laser and platelet-rich plasma for the treatment of nonsegmental vitiligo: A prospective comparative study. J Cosmet Dermatol. 2020 Apr;19(4):869-877. doi: 10.1111/jocd.13103. Epub 2019 Sep 21.
PMID: 31541597BACKGROUNDWong L, Vasconez HC. Patient satisfaction after Nd:YAG laser-assisted lipolysis. Ann Plast Surg. 2011 May;66(5):561-3. doi: 10.1097/SAP.0b013e31820b3d1e.
PMID: 21451378BACKGROUNDDoghaim NN, Gheida SF, El-Tatawy RA, Mohammed Ali DA. Combination of fractional carbon dioxide laser with narrow band ultraviolet B to induce repigmentation in stable vitiligo: A comparative study. J Cosmet Dermatol. 2019 Feb;18(1):142-149. doi: 10.1111/jocd.12553. Epub 2018 Apr 30.
PMID: 29707867BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Yasmin Tawfik, DR
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Masking Details
- no masking
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
September 26, 2020
First Posted
October 6, 2020
Study Start
January 1, 2021
Primary Completion
January 1, 2022
Study Completion
April 1, 2022
Last Updated
October 22, 2020
Record last verified: 2020-09