Fractional Carbon Dioxide Laser,Topical Corticosteroid and Narrow Band Ultraviolet B in Treatment of Stable Vitiligo

NCT03158675 | Unknown

• 1 other identifier: FCO2L
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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. 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 .

Conditions

Vitiligo

Keywords

fractional co2 laser, topical steroid,UVB narrow band

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (2)

• Scoring system of repigmentation

  4 months

• Patient satisfaction

  4 months

Study Arms (1)

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.

Procedure: fractional carbon dioxide(CO2) laser; Drug: Topical corticosteroid; Radiation: Ultraviolet B narrow band

Interventions

fractional carbon dioxide(CO2) laser PROCEDURE

-Fractional CO2 laser: Laser sessions will be performed at half month interval and it will be used with a wave length of 10,600nm.

Also known as: Laser

Fractional co2 laser&topical steroid

Topical corticosteroid DRUG

Topical corticosteroid will be applyed twice weekly on both sides for 4 months.

Also known as: Topical steroid

Fractional co2 laser&topical steroid

Ultraviolet B narrow band RADIATION

Ultraviolet B narrow band will be performed (wave length ranged from 300 to 320nm).The sessions will be performed twice weekly for 4 months.

Also known as: Phototherapy

Fractional co2 laser&topical steroid

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age ≥ 14 years old.
• Any sex

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• 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.

  PMID: 21824124 BACKGROUND

• Beachkofsky 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.

  PMID: 21492302 BACKGROUND

• Benzekri 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.

  PMID: 23464539 BACKGROUND

• Cui 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.

  PMID: 1714927 BACKGROUND

• Dillon 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.

  PMID: 28210378 BACKGROUND

• Ezzedine 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.

  PMID: 22417114 BACKGROUND

• Finlay 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.

  PMID: 8033378 BACKGROUND

• Hamzavi 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.

  PMID: 15210457 BACKGROUND

• Ito 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.

  PMID: 17507982 BACKGROUND

• Li 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.

  PMID: 25753514 BACKGROUND

• Mulekar 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.

  PMID: 24098901 BACKGROUND

• Salman 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.

  PMID: 26818062 BACKGROUND

• Vachiramon 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.

  PMID: 26175036 BACKGROUND

MeSH Terms

Conditions

Vitiligo

Interventions

Lasers; Adrenal Cortex Hormones; Steroids; Phototherapy

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fused-Ring Compounds; Polycyclic Compounds; Therapeutics

Study Officials

• Muna Abdullah

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia Attalla, prof

CONTACT

00201005677229; daliaattallah@yahoo.com

Doaa Abou-Taleb, Dr

CONTACT

00201001463937; Dodda_aboutaleb@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: • 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.

Study Record Dates

• First Submitted: May 13, 2017
• First Posted: May 18, 2017
• Study Start: December 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share