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

March 12, 2012
April 5, 2014
March 2012
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01559584 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Alopecia Areata
  • 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.

  • Drug: Triamcinolone Acetonide
    One monthly injections of intralesional triamcinolone acetonide
  • 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.

    Intervention: Radiation: ultraviolet A (UVA)
  • Active Comparator: Conventional therapy
    One monthly injections of intralesional potent corticosteroids
    Intervention: Drug: Triamcinolone Acetonide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01559584
Phototoxic UVA in alopecia
Yes
Hoda Mohamed Rasheed, Cairo University
Cairo University
Not Provided
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
Cairo University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP