- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04803461
Catecholamines Level in Vitiligo Patients Before and After Excimer Light
Catecholamines Level in Urine and Serum in Stable Non-segmental Vitiligo Patients Before and After Excimer Light
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite much research, the etiology of vitiligo and the causes of melanocyte death are not clear. Conventionally, there have been three hypotheses to explain the pathogenesis of vitiligo: neural, immune and self-destructive, but none can completely explain the disease and are probably interrelated.
From therapeutic and prognostic viewpoint, vitiligo is broadly classified in two major subtypes, segmental vitiligo (SV) including focal lesions confined to a segment of the body that does not progress towards generalized disease; and non-segmental vitiligo (NSV) which comprises all generalized usually symmetrical forms, including acrofacial vitiligo.
The increased release of catecholamines (CA) from the autonomic nerve endings in the micro-environment of melanocytes in the affected skin areas might be involved in the aetiopathogenesis of vitiligo through two main mechanisms: a direct cytotoxic action of CA and/or their o-diphenol catabolites and an indirect action, skin and mucosa arterioles possess receptors, activation of which by CA discharge may cause a severe vasoconstriction, leading to epidermal and dermal hypoxia with excessive production of toxic oxyradicals generated by different pathways.In both cases, a genetic predisposition due to insufficient radical scavengers in the affected areas should be taken into account.
First line of non-surgical therapy includes topical corticosteroid therapy and phototherapy (solar exposition, Psoralen + UVA (PUVA), narrowband UVB (NB-UVB). (8-10). The NB-UVB is now considered as the best treatment for extensive vitiligo vulgaris due to its relatively good efficacy and excellent tolerance .
Contrary to the majority of laser devices, the 308-nm excimer laser is not a ''destructive'' form of therapy but induces photobiological effects similar to selective UVB phototherapy (311-312 nm).As for UVB phototherapy, it could be judged that the efficiency of the 308-nm excimer laser in treating vitiligo depends on immunomodulatory effects (induction of the secretion of cytokines, T-lymphocytes apoptosis) and stimulation of melanocyte migration and proliferation from the niche located in hair follicles. The 308-nm excimer laser allows a selective treatment of the lesions. This device has already shown interesting results in post-resurfacing leukoderma.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Azza Mahfouz, professor
- Phone Number: 01001801039
- Email: azzamahfouz@yahoo.com
Study Contact Backup
- Name: Reham Maher, Lecturer
- Phone Number: 01005043777
- Email: rehamaher707@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with clinically stable non-segmental vitiligo of different ages and sex treated with excimer light
Exclusion Criteria:
Pregnant and lactating women.
- Personal history of hypertrophic scarring, melanoma or other skin cancer.
- Immunosuppression or taking immunosuppressive or photosensitizing drugs, and phototherapy or any other vitiligo treatment during the last 3 months.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum and urinary catecholamine level in stable non segmental vitiligo patients
Time Frame: three months
|
Lesions will be Patients will be treated by Excimer light twice weekly for a maximum of 20 sessions
|
three months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kent G, Al'Abadie M. Psychologic effects of vitiligo: a critical incident analysis. J Am Acad Dermatol. 1996 Dec;35(6):895-8. doi: 10.1016/s0190-9622(96)90112-7.
- Parsad D, Pandhi R, Dogra S, Kanwar AJ, Kumar B. Dermatology Life Quality Index score in vitiligo and its impact on the treatment outcome. Br J Dermatol. 2003 Feb;148(2):373-4. doi: 10.1046/j.1365-2133.2003.05097_9.x. No abstract available.
- Westerhof W, d'Ischia M. Vitiligo puzzle: the pieces fall in place. Pigment Cell Res. 2007 Oct;20(5):345-59. doi: 10.1111/j.1600-0749.2007.00399.x.
- Gauthier Y, Cario Andre M, Taieb A. A critical appraisal of vitiligo etiologic theories. Is melanocyte loss a melanocytorrhagy? Pigment Cell Res. 2003 Aug;16(4):322-32. doi: 10.1034/j.1600-0749.2003.00070.x.
- Morrone A, Picardo M, de Luca C, Terminali O, Passi S, Ippolito F. Catecholamines and vitiligo. Pigment Cell Res. 1992 Mar;5(2):65-9. doi: 10.1111/j.1600-0749.1992.tb00003.x.
- Cucchi ML, Frattini P, Santagostino G, Orecchia G. Higher plasma catecholamine and metabolite levels in the early phase of nonsegmental vitiligo. Pigment Cell Res. 2000 Feb;13(1):28-32. doi: 10.1034/j.1600-0749.2000.130106.x.
- Mofty ME, Zaher H, Esmat S, Youssef R, Shahin Z, Bassioni D, Enani GE. PUVA and PUVB in vitiligo--are they equally effective? Photodermatol Photoimmunol Photomed. 2001 Aug;17(4):159-63. doi: 10.1034/j.1600-0781.2001.170403.x.
- Scherschun L, Kim JJ, Lim HW. Narrow-band ultraviolet B is a useful and well-tolerated treatment for vitiligo. J Am Acad Dermatol. 2001 Jun;44(6):999-1003. doi: 10.1067/mjd.2001.114752.
- Taneja A. Treatment of vitiligo. J Dermatolog Treat. 2002 Mar;13(1):19-25. doi: 10.1080/09546630252775207.
- Friedman PM, Geronemus RG. Use of the 308-nm excimer laser for postresurfacing leukoderma. Arch Dermatol. 2001 Jun;137(6):824-5. No abstract available.
- Ostovari N, Passeron T, Zakaria W, Fontas E, Larouy JC, Blot JF, Lacour JP, Ortonne JP. Treatment of vitiligo by 308-nm excimer laser: an evaluation of variables affecting treatment response. Lasers Surg Med. 2004;35(2):152-6. doi: 10.1002/lsm.20057.
- Lilly E, Lu PD, Borovicka JH, Victorson D, Kwasny MJ, West DP, Kundu RV. Development and validation of a vitiligo-specific quality-of-life instrument (VitiQoL). J Am Acad Dermatol. 2013 Jul;69(1):e11-8. doi: 10.1016/j.jaad.2012.01.038. Epub 2012 Feb 25.
- Rossiter ND, Chapman P, Haywood IA. How big is a hand? Burns. 1996 May;22(3):230-1. doi: 10.1016/0305-4179(95)00118-2.
- Schallreuter KU, Wood JM, Lemke KR, Levenig C. Treatment of vitiligo with a topical application of pseudocatalase and calcium in combination with short-term UVB exposure: a case study on 33 patients. Dermatology. 1995;190(3):223-9. doi: 10.1159/000246690.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLIVP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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