NCT04803461

Brief Summary

Vitiligo is an acquired cutaneous disorder of pigmentation, with a 1-2% incidence worldwide, without predilection for sex or race. People affected by vitiligo have a vast reduction of quality of life, caused by the color contrast between healthy pigmented skin and the depigmented vitiligo patches due to death of melanocytes, which may cause psychological problems to the patient.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 13, 2021

Last Update Submit

March 16, 2021

Conditions

Vitiligo, Generalized

Outcome Measures

Primary Outcomes (1)

  • serum and urinary catecholamine level in stable non segmental vitiligo patients

    Lesions will be Patients will be treated by Excimer light twice weekly for a maximum of 20 sessions * Catecholamines level will be measured in urine and serum before beginning of sessions. * catecholamines level in urine and serum will be measured after completion of sessions.

    three months

Interventions

serum and urinary catecholaminesDIAGNOSTIC_TEST

estimation of level of serum and urinary catecholamines before and after excimer light treatment for patient with non segmental vitiligo.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Our study will include 21 stable non segmental vitiligo patients subjected to excimer light treatment .All patients will be recruited from the outpatient clinic of dermatology and andrology department of Assiut University.

You may qualify if:

  • Patients with clinically stable non-segmental vitiligo of different ages and sex treated with excimer light

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 8959947BACKGROUND

  • 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.

    PMID: 12588405BACKGROUND

  • 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.

    PMID: 17850508BACKGROUND

  • 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.

    PMID: 12859615BACKGROUND

  • 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.

    PMID: 1321419BACKGROUND

  • 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.

    PMID: 10761993BACKGROUND

  • 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.

    PMID: 11499536BACKGROUND

  • 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.

    PMID: 11369913BACKGROUND

  • Taneja A. Treatment of vitiligo. J Dermatolog Treat. 2002 Mar;13(1):19-25. doi: 10.1080/09546630252775207.

    PMID: 12006134BACKGROUND

  • 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.

    PMID: 11405786BACKGROUND

  • 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.

    PMID: 15334620BACKGROUND

  • 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.

    PMID: 22365883BACKGROUND

  • 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.

    PMID: 8726264BACKGROUND

  • 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.

    PMID: 7599386BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Serum

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Azza Mahfouz, professor

CONTACT

01001801039azzamahfouz@yahoo.com

Reham Maher, Lecturer

CONTACT

01005043777rehamaher707@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 13, 2021

First Posted

March 17, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

September 30, 2022

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share