Vitiligo, GeneralizedNCT04803461
Catecholamines Level in Vitiligo Patients Before and After Excimer Light
An observational study of Vitiligo, Generalized, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vitiligo, Generalized
- What is being tested?
- serum and urinary catecholamines
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with clinically stable non-segmental vitiligo of different ages and sex treated with excimer light
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Catecholamines Level in Urine and Serum in Stable Non-segmental Vitiligo Patients Before and After Excimer Light
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.
Read the 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.
- Conditions
- Vitiligo, Generalized
- Being tested
- serum and urinary catecholamines
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Vitiligo, GeneralizedStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa sayed ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803461
- Sponsor's protocol ID
- CLIVP
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 8959947Parsad 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.
PubMed 12588405Westerhof 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.
PubMed 17850508Gauthier 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.
PubMed 12859615Morrone 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.
PubMed 1321419Cucchi 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.
PubMed 10761993Mofty 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.
PubMed 11499536Scherschun 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.
PubMed 11369913Taneja A. Treatment of vitiligo. J Dermatolog Treat. 2002 Mar;13(1):19-25. doi: 10.1080/09546630252775207.
PubMed 12006134Friedman PM, Geronemus RG. Use of the 308-nm excimer laser for postresurfacing leukoderma. Arch Dermatol. 2001 Jun;137(6):824-5. No abstract available.
PubMed 11405786Ostovari 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.
PubMed 15334620Lilly 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.
PubMed 22365883Rossiter 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.
PubMed 8726264Schallreuter 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.
PubMed 7599386
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catecholamines Level in Urine and Serum in Stable Non-segmental Vitiligo Patients Before and After Excimer Light
- ClinicalTrials.gov ID
- NCT04803461
- Acronym / sponsor ID
- CLIVP
- Conditions
- Vitiligo, Generalized
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with clinically stable non-segmental vitiligo of different ages and sex treated with excimer light
Key exclusion criteria (3 listed)
- Pregnant and lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum and urinary catecholaminesestimation of level of serum and urinary catecholamines before and after excimer light treatment for patient with non segmental vitiligo. | Diagnostic test | – |
Primary outcome
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 * 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 8959947Kent 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.
- Background: PubMed 12588405Parsad 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.
- Background: PubMed 17850508Westerhof 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.
- Background: PubMed 12859615Gauthier 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.
- Background: PubMed 1321419Morrone 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.
- Background: PubMed 10761993Cucchi 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.
- Background: PubMed 11499536Mofty 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.
- Background: PubMed 11369913Scherschun 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.
- Background: PubMed 12006134Taneja A. Treatment of vitiligo. J Dermatolog Treat. 2002 Mar;13(1):19-25. doi: 10.1080/09546630252775207.
- Background: PubMed 11405786Friedman PM, Geronemus RG. Use of the 308-nm excimer laser for postresurfacing leukoderma. Arch Dermatol. 2001 Jun;137(6):824-5. No abstract available.
- Background: PubMed 15334620Ostovari 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.
- Background: PubMed 22365883Lilly 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo, Generalized, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azza Mahfouz, professor (01001801039, azzamahfouz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum and urinary catecholamine level in stable non segmental vitiligo patients (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803461, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.