VitiligoNCT03158675
Fractional Carbon Dioxide Laser,Topical Corticosteroid and Narrow Band Ultraviolet B in Treatment of Stable Vitiligo
A study testing fractional carbon dioxide(CO2) laser, Topical corticosteroid and Ultraviolet B narrow band in people with Vitiligo, run by Assiut University.
Trial summary
Vitiligo is an acquired disease with a variable course. It is characterized clinically by well-defined depigmented macules or patches thought to occur secondary to melanocyte dysfunction and loss. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- fractional carbon dioxide(CO2) laser, Topical corticosteroid and Ultraviolet B narrow band
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Jul 2019
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient age ≥ 14 years old.
- Any sex
Who cannot join
- Patients less than 14 years old.
- Patients with new, spreading lesions of vitiligo within the preceding 6 months.
- Pregnant female patients.
- Patients with history of keloid formation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Fractional Carbon Dioxide Laser Combined With Topical Corticosteroid and Narrow Band Ultraviolet B in Treatment of Stable Vitiligo.
Vitiligo is an acquired disease with a variable course. It is characterized clinically by well-defined depigmented macules or patches thought to occur secondary to melanocyte dysfunction and loss. it is the most common depigmentation disorder, affecting approximately 0.5 to 2.0 percent of the population and has no predilection for gender or race .
Read the detailed description
Vitiligo is primarily a clinical diagnosis without the need for diagnostic tools. It classified into three types: segmental vitiligo , nonsegmental vitiligo , and unclassifiable vitiligo .
Onset and disease course may vary by subtype .Although the disease is typically asymptomatic and non-fatal; the profound cosmetic disfigurement it produces has a significant negative impact on the patient's quality of life .
Vitiligo occurs due to a complex interaction among genetic, environmental and immunologic factors. This ultimately leads to melanocyte damage resulting characteristic depigmented lesions.
Conventional vitiligo treatments include topical steroid, topical and oral immunomodulators and phototherapy. In spite of much advancement in pharmacotherapy, treatment for vitiligo still remains a challenge for physicians. Re-pigmentation of the lesions on the extremities or over bony prominences is particularly poor due to the reduced numbers of follicle-based melanocytes in these areas .
Treatment of vitiligo with narrowband ultraviolet B light is an important component of the current standard of care.Narrowband ultraviolet B therapy or topical corticosteroid has long been used in vitiligo. However, the re-pigmentation is always transient and time-consuming .
Using surgical therapies (Dermabrasion) may increase the rate of re-pigmentation or erbium-doped yttrium aluminum garnet laser to stimulate melanocyte stem cells and enhance drug absorption and autoinoculation of melanocytes from the margin, but create wounds that take a longer time to heal . In addition to being costly and time consuming, special training, staff, and equipment are needed in order to perform the procedures.
Fractional carbon dioxide lasers, originally developed for tissue rejuvenation and scar remodeling. Recently, it has been used in the treatment of vitiligo. The newly developed fractional carbon dioxide laser does not ablate the entire epidermis, leaving intact skin between coagulated necrotic columns. It decreases risk of potential side effects and minimizes duration of sick leave.
Several mechanisms may contribute to explain the improvement of Vitiligo after fractional carbon dioxide laser sessions. Firstly, wounding therapies may regenerate de novo hair follicles by Wnt-dependant pathway .Moreover the role of hair follicles in the repigmentation of Vitiligo is longstanding knowledge . Secondly, wounding therapies and fractional wounding-therapies may increase the penetration and the well-known efficiency of ultraviolet-radiation. Thirdly, they may induce the activation, proliferation and migration of melanoblasts from the border areas or differentiation of stem cells from the dermis of lesions by initiating propigmenting cytokinic inflammatory cascades .
Adding fractional carbon dioxide laser treatment to the conventional therapies of vitiligo may improve repigmentation rate as well as patient satisfaction .
Aim of the Work :
To evaluate the use of fractional Co2 laser combined with topical corticosteroid and ultraviolet B narrow band( UVB-NB) in treatment of stable vitiligo.
- Conditions
- Vitiligo
- Being tested
- fractional carbon dioxide(CO2) laser, Topical corticosteroid, Ultraviolet B narrow band
- Keywords
- fractional co2 laser, topical steroid,UVB narrow band
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional carbon dioxide(CO2) laserProcedure or surgery
Also called Laser
-Fractional CO2 laser: Laser sessions will be performed at half month interval and it will be used with a wave length of 10,600nm.
Topical corticosteroidDrug
Also called Topical steroid
Topical corticosteroid will be applyed twice weekly on both sides for 4 months.
Ultraviolet B narrow bandRadiation
Also called Phototherapy
Ultraviolet B narrow band will be performed (wave length ranged from 300 to 320nm).The sessions will be performed twice weekly for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Fractional co2 laser&topical steroid | Experimental | participant will be compared with one side of the body to the ather side.
Intervention:
-Procedure: Fractional carbon dioxide laser.
-Drug: Topical corticosteroid.
-Radiation: Ultraviolet B narrow band. Receives: Procedure: fractional carbon dioxide(CO2) laser; Drug: Topical corticosteroid; Radiation: Ultraviolet B narrow band |
What is being measured
The primary outcome is the main question the study is designed to answer.
VASI scor-Vitiligo Area and Severity Index:
Vitiligo Area and Severity Index (VASI) One hand unit ,which encompasses the palm plus the volar surface of all the digits,is approximately 1% of the total body surface area and is used as a guide to estimate the baseline percentage of vitiligo involvement in each body region.The body is divided into five separate and mutually exclusive regions: hands ,upper extremities (excluding hands),trunk,lower extremities(excluding feet),and feet.The axillary region is included with the upper extremities while the buttocks and inguinal areas are included with the lower extremities.The extent of residual depigmentation is expressed by the following percentages:0,10%,25%,50%,75%,90%,or100%.At 100% depigmentation,no pigment is present; at 90%,specks of pigment is present; at75%,the depigmented area exceeds the pigmented area; at50%,the depigmented and pigmented area are equal; at 25%,the pigmented area exceeds the depigmented area; at10% only specks of depigmentation are present.
Measured: 4 months
Secondary outcomes (2)
Scoring system of repigmentation
- G0,<25% repigmentation (poor)
- G1,25-50% repigmentation (fair)
- G2,50-75% repigmentation (good)
- G3,>75% repigmentation (excellent).
Measured: 4 months
Patient satisfaction
- 0 - not satisfactory
- to 10 - very satisfactory
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startDec 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- • Methods:- -In each patient: The lesions on one side of the body will be randomly allocated to group A, and the lesions on the other side to group B. Group A: will be treated with fractional CO2 laser combined with topical corticosteroid and UVB-NB. Group B: will be treated with topical corticosteroid and UVB-NB.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUAAhmed, Assiut University
- Investigators
- Muna Abdullah, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158675
- Sponsor's protocol ID
- FCO2L
- Status last verified
- Nov 2018
- First submitted
- 13 May 2017
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayoumi W, Fontas E, Sillard L, Le Duff F, Ortonne JP, Bahadoran P, Lacour JP, Passeron T. Effect of a preceding laser dermabrasion on the outcome of combined therapy with narrowband ultraviolet B and potent topical steroids for treating nonsegmental vitiligo in resistant localizations. Br J Dermatol. 2012 Jan;166(1):208-11. doi: 10.1111/j.1365-2133.2011.10564.x. Epub 2011 Nov 17.
PubMed 21824124Beachkofsky TM, Henning JS, Hivnor CM. Induction of de novo hair regeneration in scars after fractionated carbon dioxide laser therapy in three patients. Dermatol Surg. 2011 Sep;37(9):1365-8. doi: 10.1111/j.1524-4725.2011.01934.x. Epub 2011 Apr 14. No abstract available.
PubMed 21492302Benzekri L, Ezzedine K, Gauthier Y. Vitiligo Potential Repigmentation Index: a simple clinical score that might predict the ability of vitiligo lesions to repigment under therapy. Br J Dermatol. 2013 May;168(5):1143-6. doi: 10.1111/bjd.12147. Epub 2013 Mar 7. No abstract available.
PubMed 23464539Cui J, Shen LY, Wang GC. Role of hair follicles in the repigmentation of vitiligo. J Invest Dermatol. 1991 Sep;97(3):410-6. doi: 10.1111/1523-1747.ep12480997.
PubMed 1714927Dillon AB, Sideris A, Hadi A, Elbuluk N. Advances in Vitiligo: An Update on Medical and Surgical Treatments. J Clin Aesthet Dermatol. 2017 Jan;10(1):15-28. Epub 2017 Jan 1.
PubMed 28210378Ezzedine K, Lim HW, Suzuki T, Katayama I, Hamzavi I, Lan CC, Goh BK, Anbar T, Silva de Castro C, Lee AY, Parsad D, van Geel N, Le Poole IC, Oiso N, Benzekri L, Spritz R, Gauthier Y, Hann SK, Picardo M, Taieb A; Vitiligo Global Issue Consensus Conference Panelists. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012 May;25(3):E1-13. doi: 10.1111/j.1755-148X.2012.00997.x.
PubMed 22417114Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
PubMed 8033378Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.
PubMed 15210457Ito M, Yang Z, Andl T, Cui C, Kim N, Millar SE, Cotsarelis G. Wnt-dependent de novo hair follicle regeneration in adult mouse skin after wounding. Nature. 2007 May 17;447(7142):316-20. doi: 10.1038/nature05766.
PubMed 17507982Li L, Wu Y, Li L, Sun Y, Qiu L, Gao XH, Chen HD. Triple combination treatment with fractional CO2 laser plus topical betamethasone solution and narrowband ultraviolet B for refractory vitiligo: a prospective, randomized half-body, comparative study. Dermatol Ther. 2015 May-Jun;28(3):131-4. doi: 10.1111/dth.12202. Epub 2015 Mar 5.
PubMed 25753514Mulekar SV, Isedeh P. Surgical interventions for vitiligo: an evidence-based review. Br J Dermatol. 2013 Oct;169 Suppl 3:57-66. doi: 10.1111/bjd.12532.
PubMed 24098901Salman A, Kurt E, Topcuoglu V, Demircay Z. Social Anxiety and Quality of Life in Vitiligo and Acne Patients with Facial Involvement: A Cross-Sectional Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):305-11. doi: 10.1007/s40257-016-0172-x.
PubMed 26818062Vachiramon V, Chaiyabutr C, Rattanaumpawan P, Kanokrungsee S. Effects of a preceding fractional carbon dioxide laser on the outcome of combined local narrowband ultraviolet B and topical steroids in patients with vitiligo in difficult-to-treat areas. Lasers Surg Med. 2016 Feb;48(2):197-202. doi: 10.1002/lsm.22389. Epub 2015 Jul 14.
PubMed 26175036
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Carbon Dioxide Laser Combined With Topical Corticosteroid and Narrow Band Ultraviolet B in Treatment of Stable Vitiligo.
- ClinicalTrials.gov ID
- NCT03158675
- Acronym / sponsor ID
- FCO2L
- Conditions
- Vitiligo
- Keywords
- fractional co2 laser, topical steroid,UVB narrow band
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 18 May 2017 (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 disease with a variable course. It is characterized clinically by well-defined depigmented macules or patches thought to occur secondary to melanocyte dysfunction and loss. it is the most common depigmentation disorder, affecting approximately 0.5 to 2.0 percent of the population and has no predilection for gender or race .
Detailed description
Vitiligo is primarily a clinical diagnosis without the need for diagnostic tools. It classified into three types: segmental vitiligo , nonsegmental vitiligo , and unclassifiable vitiligo .
Onset and disease course may vary by subtype .Although the disease is typically asymptomatic and non-fatal; the profound cosmetic disfigurement it produces has a significant negative impact on the patient's quality of life .
Vitiligo occurs due to a complex interaction among genetic, environmental and immunologic factors. This ultimately leads to melanocyte damage resulting characteristic depigmented lesions.
Conventional vitiligo treatments include topical steroid, topical and oral immunomodulators and phototherapy. In spite of much advancement in pharmacotherapy, treatment for vitiligo still remains a challenge for physicians. Re-pigmentation of the lesions on the extremities or over bony prominences is particularly poor due to the reduced numbers of follicle-based melanocytes in these areas .
Treatment of vitiligo with narrowband ultraviolet B light is an important component of the current standard of care.Narrowband ultraviolet B therapy or topical corticosteroid has long been used in vitiligo. However, the re-pigmentation is always transient and time-consuming .
Using surgical therapies (Dermabrasion) may increase the rate of re-pigmentation or erbium-doped yttrium aluminum garnet laser to stimulate melanocyte stem cells and enhance drug absorption and autoinoculation of melanocytes from the margin, but create wounds that take a longer time to heal . In addition to being costly and time consuming, special training, staff, and equipment are needed in order to perform the procedures.
Fractional carbon dioxide lasers, originally developed for tissue rejuvenation and scar remodeling. Recently, it has been used in the treatment of vitiligo. The newly developed fractional carbon dioxide laser does not ablate the entire epidermis, leaving intact skin between coagulated necrotic columns. It decreases risk of potential side effects and minimizes duration of sick leave.
Several mechanisms may contribute to explain the improvement of Vitiligo after fractional carbon dioxide laser sessions. Firstly, wounding therapies may regenerate de novo hair follicles by Wnt-dependant pathway .Moreover the role of hair follicles in the repigmentation of Vitiligo is longstanding knowledge . Secondly, wounding therapies and fractional wounding-therapies may increase the penetration and the well-known efficiency of ultraviolet-radiation. Thirdly, they may induce the activation, proliferation and migration of melanoblasts from the border areas or differentiation of stem cells from the dermis of lesions by initiating propigmenting cytokinic inflammatory cascades .
Adding fractional carbon dioxide laser treatment to the conventional therapies of vitiligo may improve repigmentation rate as well as patient satisfaction .
Aim of the Work :
To evaluate the use of fractional Co2 laser combined with topical corticosteroid and ultraviolet B narrow band( UVB-NB) in treatment of stable vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- • Methods:- -In each patient: The lesions on one side of the body will be randomly allocated to group A, and the lesions on the other side to group B. Group A: will be treated with fractional CO2 laser combined with topical corticosteroid and UVB-NB. Group B: will be treated with topical corticosteroid and UVB-NB.
| Arm | Type | Receives |
|---|---|---|
| Fractional co2 laser&topical steroid | Experimental | Procedure: fractional carbon dioxide(CO2) laser, Drug: Topical corticosteroid, Radiation: Ultraviolet B narrow bandparticipant will be compared with one side of the body to the ather side. Intervention: -Procedure: Fractional carbon dioxide laser. -Drug: Topical corticosteroid. -Radiation: Ultraviolet B narrow band. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient age ≥ 14 years old.
- Any sex
Key exclusion criteria (4 listed)
- Patients less than 14 years old.
- Patients with new, spreading lesions of vitiligo within the preceding 6 months.
- Pregnant female patients.
- Patients with history of keloid formation.
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 |
|---|---|---|
| fractional carbon dioxide(CO2) laserAlso: Laser-Fractional CO2 laser: Laser sessions will be performed at half month interval and it will be used with a wave length of 10,600nm. | Procedure or surgery | Fractional co2 laser&topical steroid |
| Topical corticosteroidAlso: Topical steroidTopical corticosteroid will be applyed twice weekly on both sides for 4 months. | Drug | Fractional co2 laser&topical steroid |
| Ultraviolet B narrow bandAlso: PhototherapyUltraviolet B narrow band will be performed (wave length ranged from 300 to 320nm).The sessions will be performed twice weekly for 4 months. | Radiation | Fractional co2 laser&topical steroid |
Primary outcome
VASI scor-Vitiligo Area and Severity Index:
Time frame: 4 months
Vitiligo Area and Severity Index (VASI) One hand unit ,which encompasses the palm plus the volar surface of all the digits,is approximately 1% of the total body surface area and is used as a guide to estimate the baseline percentage of vitiligo involvement in each body region.The body is divided into five separate and mutually exclusive regions: hands ,upper extremities (excluding hands),trunk,lower extremities(excluding feet),and feet.The axillary region is included with the upper extremities while the buttocks and inguinal areas are included with the lower extremities.The extent of residual depigmentation is expressed by the following percentages:0,10%,25%,50%,75%,90%,or100%.At 100% depigmentation,no pigment is present; at 90%,specks of pigment is present; at75%,the depigmented area exceeds the pigmented area; at50%,the depigmented and pigmented area are equal; at 25%,the pigmented area exceeds the depigmented area; at10% only specks of depigmentation are present.
2 secondary outcomes
Scoring system of repigmentation
Time frame: 4 months
Patient satisfaction
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Background: PubMed 21824124Bayoumi W, Fontas E, Sillard L, Le Duff F, Ortonne JP, Bahadoran P, Lacour JP, Passeron T. Effect of a preceding laser dermabrasion on the outcome of combined therapy with narrowband ultraviolet B and potent topical steroids for treating nonsegmental vitiligo in resistant localizations. Br J Dermatol. 2012 Jan;166(1):208-11. doi: 10.1111/j.1365-2133.2011.10564.x. Epub 2011 Nov 17.
- Background: PubMed 21492302Beachkofsky TM, Henning JS, Hivnor CM. Induction of de novo hair regeneration in scars after fractionated carbon dioxide laser therapy in three patients. Dermatol Surg. 2011 Sep;37(9):1365-8. doi: 10.1111/j.1524-4725.2011.01934.x. Epub 2011 Apr 14. No abstract available.
- Background: PubMed 23464539Benzekri L, Ezzedine K, Gauthier Y. Vitiligo Potential Repigmentation Index: a simple clinical score that might predict the ability of vitiligo lesions to repigment under therapy. Br J Dermatol. 2013 May;168(5):1143-6. doi: 10.1111/bjd.12147. Epub 2013 Mar 7. No abstract available.
- Background: PubMed 1714927Cui J, Shen LY, Wang GC. Role of hair follicles in the repigmentation of vitiligo. J Invest Dermatol. 1991 Sep;97(3):410-6. doi: 10.1111/1523-1747.ep12480997.
- Background: PubMed 28210378Dillon AB, Sideris A, Hadi A, Elbuluk N. Advances in Vitiligo: An Update on Medical and Surgical Treatments. J Clin Aesthet Dermatol. 2017 Jan;10(1):15-28. Epub 2017 Jan 1.
- Background: PubMed 22417114Ezzedine K, Lim HW, Suzuki T, Katayama I, Hamzavi I, Lan CC, Goh BK, Anbar T, Silva de Castro C, Lee AY, Parsad D, van Geel N, Le Poole IC, Oiso N, Benzekri L, Spritz R, Gauthier Y, Hann SK, Picardo M, Taieb A; Vitiligo Global Issue Consensus Conference Panelists. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012 May;25(3):E1-13. doi: 10.1111/j.1755-148X.2012.00997.x.
- Background: PubMed 8033378Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
- Background: PubMed 15210457Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.
- Background: PubMed 17507982Ito M, Yang Z, Andl T, Cui C, Kim N, Millar SE, Cotsarelis G. Wnt-dependent de novo hair follicle regeneration in adult mouse skin after wounding. Nature. 2007 May 17;447(7142):316-20. doi: 10.1038/nature05766.
- Background: PubMed 25753514Li L, Wu Y, Li L, Sun Y, Qiu L, Gao XH, Chen HD. Triple combination treatment with fractional CO2 laser plus topical betamethasone solution and narrowband ultraviolet B for refractory vitiligo: a prospective, randomized half-body, comparative study. Dermatol Ther. 2015 May-Jun;28(3):131-4. doi: 10.1111/dth.12202. Epub 2015 Mar 5.
- Background: PubMed 24098901Mulekar SV, Isedeh P. Surgical interventions for vitiligo: an evidence-based review. Br J Dermatol. 2013 Oct;169 Suppl 3:57-66. doi: 10.1111/bjd.12532.
- Background: PubMed 26818062Salman A, Kurt E, Topcuoglu V, Demircay Z. Social Anxiety and Quality of Life in Vitiligo and Acne Patients with Facial Involvement: A Cross-Sectional Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):305-11. doi: 10.1007/s40257-016-0172-x.
- Individual participant dataSharing planned: No
Related trials for Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
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.
Muna Abdullah principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing fractional carbon dioxide(CO2) laser, Topical corticosteroid and Ultraviolet B narrow band in people with Vitiligo, 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 2 inclusion and 4 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 28 Nov 2018. 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 Dalia Attalla, prof (00201005677229, daliaattallah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VASI scor-Vitiligo Area and Severity Index: (time frame: 4 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 NCT03158675, which also lists 13 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 28 Nov 2018.