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

February 16, 2022 updated by: Iltefat Hamzavi, Henry Ford Health System
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Vitiligo is an acquired disorder of pigmentation. The depigmented regions present as white macules and patches and can occur at any age. The vitiligo patches may be asymptomatic, pruritic or may sunburn. Vitiligo has been shown to significantly impact the quality of life and also has an associated psychological burden. Therefore, treatment of vitiligo is essential. Various treatment modalities such as topical corticosteroids, topical calcineurin inhibitors, systemic steroids, surgery, and phototherapy exist to treat vitiligo. UV based phototherapy includes NBUVB, targeted phototherapy, psoralen and UVA photochemotherapy (1-3).

NBUVB is a proven, effective, and well-accepted treatment as part of the standard of care for vitiligo. NBUVB has a sharp emission peak at 311-313 nm. NBUVB is a relatively safe treatment modality, but can cause phototoxic reactions and tanning. Studies have shown that treatment with NBUVB improves the Vitiligo Area Scoring Index by 42% over a period of 6 months. Approximately half of patients should expect 50% repigmentation by 6 months of 2-3x per week phototherapy (4-6). However, a portion of patients are slow responders requiring up to 72 treatments before notable repigmentation has been achieved.

To complicate matters further, about 1/3 of the patients with vitiligo do not photoadapt, meaning the patient does not exhibit a diminished erythema (redness) to equivalent doses of NBUVB upon future irradiations (7). Photoadaption is the principle behind needing to increase the NBUVB dose for all phototherapy regimens (atopic dermatitis, psoriasis, mycosis fungiodes, vitiligo, etc) and why people are able to tolerate longer solar exposure at the end of summer rather than the beginning. It is thought that the non-photoadapters do not respond to NBUVB as their photoadpative capacity may be genetically predetermined (7).

Repigmentation from NBUVB therapy has shown dramatic improvements in quality of life scores (QOL). Tijoe et. al reported 70% improvement in QOL with long term UVB therapy (8). Therefore, identifying adjunctive therapies that can enable non-photoadapters to safely tolerate therapeutic NBUVB doses can significantly raise their QOL. In addition, these therapies can be expanded into the treatment of photoadapters receiving NBUVB to permit higher dose escalations and fewer phototherapy sessions to achieve a therapeutic NBUVB vitiligo dose. This can in-turn potentially decrease health care costs for increased treatments. Also, the patient may experience fewer long-term side effect associated with NBUVB since they may need fewer sessions of NBUVB.

A possible way for non-photoadapters to tolerate NBUVB may be with the use of NSAIDs. Studies performed have shown that the use of NSAIDs showed increased minimal erythema dose by possibly suppressing the immune response by inhibiting cyclooxygenase and prostaglandins (9). Ibuprofen has also shown to decrease inflammation induced by UVB phototherapy (10). Thus, ibuprofen may increase the MED in non-photoadapters.

Therefore, the goal of this study is to see if the use of ibuprofen, an NSAID, will allow for nonphotoadpaters to respond to NBUVB treatments.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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
Patient will receive ibuprofen 400 mg before the phototherapy session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitiligo Area Scoring Index (VASI)
Time Frame: 4 months
Investigator will assess surface area of vitiligo using VASI
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

May 24, 2016

Study Completion (Actual)

May 24, 2016

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9744

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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