Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata

April 5, 2014 updated by: Hoda Mohamed Rasheed, Cairo University

A Clinical and Immunological Study of Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata: A Randomized Controlled Clinical Trial

Alopecia areata (AA) is a disease of the hair follicles with multifactorial etiology and a strong component of autoimmune origin. It is characterized by non-scarring hair loss on the scalp or any hair-bearing surface.

Various therapeutic agents have been described for the treatment of AA, but none are curative or preventive. The aim of AA treatment is to suppress the activity of the disease. Phototherapy in the form of topical psoralen and ultraviolet A (PUVA) has been a well documented therapy for AA since 1978.

A more recent technique of topical PUVA, namely phototoxic PUVA, has been adopted in two previous studies. Sessions were carried out once every 3 months, and a higher efficacy with more encouraging response rates in comparison to the conventional PUVA therapy has been documented. This assumed upper hand over the conventional PUVA might be due to increasing the amount of UV reaching the hair follicle cells and the surrounding inflammatory cells. Also it has been suggested that it might play a role as a powerful initiating agent of suppression through direct action at the DNA level. However, still the exact effect of this treatment has not been fully clarified.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Egypt
      • Cairo, Egypt
        • Dermatology department - faculty of medicine- Cairo University

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting with alopecia areata, patchy type (max 3 patches not exceeding 50% of the scalp surface area) of more than 2 months duration.
  • Age: 12 years and above

Exclusion Criteria:

  • Age: Less than 12 years old.
  • Affection of more than 50% of the scalp area
  • Diagnosis or history of local dermatological disease in the scalp apart from AA such as eczema, seborrheic dermatitis, psoriasis,..
  • Any present / past history of dermatological disease with a potential for koebnerization such as psoriasis, vitiligo.
  • Diagnosis or history of any contraindication to receiving phototherapy such as malignancy, systemic lupus
  • Dermoscopic evaluation revealing absence of any signs of presence of hair follicles.
  • Any psychiatric illness or psychological state impairing future compliance or influencing expectations of the patient.
  • Patients with AA totalis or Ophiasis

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phototherapeutic

0.5% solution of 8-methoxypsoralen (MOP) will be applied 20 minutes before UVA exposure (315-400nm).

UVA sessions will be carried out twice weekly aiming to achieve a phototoxic reaction, in the form of erythema and vesiculation. Once a phototoxic reaction will be achieved, the patient will be asked to rest until the reaction subsides and then resume the phototherapy sessions.
Radiation: ultraviolet A (UVA)

0.5% solution of 8-methoxypsoralen (MOP) will be applied 20 minutes before UVA exposure (315-400nm).

UVA sessions will be carried out twice weekly aiming to achieve a phototoxic reaction, in the form of erythema and vesiculation. Once a phototoxic reaction will be achieved, the patient will be asked to rest until the reaction subsides and then resume the phototherapy sessions.
Active Comparator: Conventional therapy
One monthly injections of intralesional potent corticosteroids
Drug: Triamcinolone Acetonide
One monthly injections of intralesional triamcinolone acetonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success
Time Frame: After six months from onset of treatment
Treatment success defined as effective sustained growth of hair in more than 80% of the affected area at the EOS. Clinical assessment will be performed by one non-blinded, and two blinded investigators.
After six months from onset of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue cytokines response to therapy
Time Frame: At early hair regrowth, but no later than three months of treatment onset, in case of failed hair regrowth
Explanation at the molecular level of possible mechanisms underlying hair regrowth in responsive patients by assessing tissue levels of IFN-γ, IGF-1 and TGF-Beta1
At early hair regrowth, but no later than three months of treatment onset, in case of failed hair regrowth
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: After six months from onset of treatment
Adverse events will be meticulously monitored all through the study, including hypo/hyper pigmentation, severe erythema, itching or burning sensation.
After six months from onset of treatment

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Olfat G Shaker, MD, Cairo University
  • Study Chair: Hoda M Rasheed, MD, Cairo University
  • Principal Investigator: Nermin El-Eishi, MD, Cairo University
  • Principal Investigator: Solwan I Elsamanoudy, MBBCh, Cairo University
  • Principal Investigator: Rehab A Hegazy, MD, Cairo University

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

March 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 5, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Phototoxic UVA in alopecia

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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