Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559584
• Other study ID #: Phototoxic UVA in alopecia
• Status: Completed
• Phase: N/A
• First received: March 12, 2012
• Last updated: April 5, 2014
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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

Locations

Country	Name	City	State
Egypt	Dermatology department - faculty of medicine- Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success	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	No
Secondary	Tissue cytokines response to therapy	Explanation at the molecular level of possible mechanisms underlying hair regrowth in responsive patients by assessing tissue levels of IFN-?, IGF-1 and TGF-Beta1	At early hair regrowth, but no later than three months of treatment onset, in case of failed hair regrowth	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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	Yes