Effect of Combination Non Steroidal Antiinflammatory Drugs and Narrowband UVB Treatment in Non-Photoadapters

NCT05256147 | Terminated

• 1 other identifier: 9744
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Narrow band UVB phototherapy is the mainstay of therapy for vitiligo. However, about 1/3 of patients cannot respond to phototherapy. The objective of this study is to determine if the use of ibuprofen can induce non-photoadapters (patients who cannot tolerate increases in NBUVB past 400 mJ/cm2 after 12 sessions) to convert to photoadapters and tolerate raising NBUVB doses to therapeutic levels

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Vitiligo Area Scoring Index (VASI)

  Investigator will assess surface area of vitiligo using VASI

  4 months

Study Arms (1)

Intervention group

EXPERIMENTAL

There is one group in this study and they will receive ibuprofen 400 mg before their narrow band UVB phototherapy session which occurs two to three times weekly. The treatment dose of NBUVB will start off at 150 mJ/cm2 and will be increased 10% as tolerated til the patient reaches 700 mJ/cm2. They will receive ibuprofen before each phototherapy session.

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

Patient will receive ibuprofen 400 mg before the phototherapy session.

Intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should have a diagnosis of vitiligo.
• Patients who are identified as nonphotoadapters (those who cannot increase NBUVB dose past 400 mJ/cm2) will be recruited for the study

You may not qualify if:

• Patients with the daily ibuprofen use, history of renal disease, cardiac disease, gastric uler and bleeding disorder will be excluded from the study. Patients with a history of lupus erythematosus and other photosensitivity disorders will be excluded from the study.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Dermatology

Detroit, Michigan, 48202, United States

Location

Related Publications (9)

• Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.

  PMID: 21839315 BACKGROUND

• Linthorst Homan MW, Spuls PI, de Korte J, Bos JD, Sprangers MA, van der Veen JP. The burden of vitiligo: patient characteristics associated with quality of life. J Am Acad Dermatol. 2009 Sep;61(3):411-20. doi: 10.1016/j.jaad.2009.03.022. Epub 2009 Jul 3.

  PMID: 19577331 BACKGROUND

• Hamzavi IH, Lim HW, Syed ZU. Ultraviolet-based therapy for vitiligo: what's new? Indian J Dermatol Venereol Leprol. 2012 Jan-Feb;78(1):42-8. doi: 10.4103/0378-6323.90945.

  PMID: 22199059 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

• 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: 11369913 BACKGROUND

• Pacifico A, Leone G. Photo(chemo)therapy for vitiligo. Photodermatol Photoimmunol Photomed. 2011 Oct;27(5):261-77. doi: 10.1111/j.1600-0781.2011.00606.x.

  PMID: 21950634 BACKGROUND

• Hexsel CL, Mahmoud BH, Mitchell D, Rivard J, Owen M, Strickland FM, Lim HW, Hamzavi I. A clinical trial and molecular study of photoadaptation in vitiligo. Br J Dermatol. 2009 Mar;160(3):534-9. doi: 10.1111/j.1365-2133.2008.08943.x. Epub 2008 Dec 5.

  PMID: 19067714 BACKGROUND

• Edwards EK Jr, Horwitz SN, Frost P. Reduction of the erythema response to ultraviolet light by nonsteroidal antiinflammatory agents. Arch Dermatol Res. 1982;272(3-4):263-7. doi: 10.1007/BF00509055.

  PMID: 7165335 BACKGROUND

• Stern RS, Dodson TB. Ibuprofen in the treatment of UV-B-induced inflammation. Arch Dermatol. 1985 Apr;121(4):508-12.

  PMID: 3883908 BACKGROUND

MeSH Terms

Conditions

Vitiligo

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

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: Dermatologist

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 25, 2022
• Study Start: August 1, 2015
• Primary Completion: May 24, 2016
• Study Completion: May 24, 2016
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

US (1)