Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoda Mohamed Rasheed, Cairo University
ClinicalTrials.gov Identifier:
NCT01559584
First received: March 12, 2012
Last updated: April 5, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Alopecia Areata
Radiation: ultraviolet A (UVA)
Drug: Triamcinolone Acetonide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical and Immunological Study of Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata: A Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Treatment success [ Time Frame: After six months from onset of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: After six months from onset of treatment ] [ Designated as safety issue: Yes ]
    Adverse events will be meticulously monitored all through the study, including hypo/hyper pigmentation, severe erythema, itching or burning sensation.


Enrollment: 40
Study Start Date: March 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559584

Locations
Egypt
Dermatology department - faculty of medicine- Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
Study Chair: Hoda M Rasheed, MD Cairo University
Principal Investigator: Nermin El-Eishi, MD Cairo University
Principal Investigator: Vanessa G Hafez, MD Cairo University
Principal Investigator: Solwan I Elsamanoudy, MBBCh Cairo University
Principal Investigator: Rehab A Hegazy, MD Cairo University
Principal Investigator: Olfat G Shaker, MD Cairo University
  More Information

No publications provided

Responsible Party: Hoda Mohamed Rasheed, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT01559584     History of Changes
Other Study ID Numbers: Phototoxic UVA in alopecia
Study First Received: March 12, 2012
Last Updated: April 5, 2014
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
Alopecia
Areata
Phototherapy
Phototoxic
Ultraviolet A
Randomized controlled trial
Interferon gamma
Transforming growth factor beta-1
Insulin like growth factor-1

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014