Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata

NCT01559584 | Completed DMC

• 1 other identifier: Phototoxic UVA in alopecia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alopecia Areata

Keywords

Alopecia; Areata; Phototherapy; Phototoxic; Ultraviolet A; Randomized controlled trial; Interferon gamma; Transforming growth factor beta-1; Insulin like growth factor-1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Tissue cytokines response to therapy

  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

  After six months from onset of treatment

Study Arms (2)

Phototherapeutic

EXPERIMENTAL

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)

Conventional therapy

ACTIVE COMPARATOR

One monthly injections of intralesional potent corticosteroids

Drug: Triamcinolone Acetonide

Interventions

ultraviolet A (UVA) RADIATION

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.

Phototherapeutic

Triamcinolone Acetonide DRUG

One monthly injections of intralesional triamcinolone acetonide

Conventional therapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dermatology department - faculty of medicine- Cairo University

Cairo, Egypt

Location

Related Publications (1)

• El-Mofty M, Rasheed H, El-Eishy N, Hegazy RA, Hafez V, Shaker O, El-Samanoudy SI. A clinical and immunological study of phototoxic regimen of ultraviolet A for treatment of alopecia areata: a randomized controlled clinical trial. J Dermatolog Treat. 2019 Sep;30(6):582-587. doi: 10.1080/09546634.2018.1543847. Epub 2019 Jan 8.

  PMID: 30411986 DERIVED

MeSH Terms

Conditions

Alopecia Areata; Alopecia; Camurati-Engelmann Syndrome

Interventions

PUVA Therapy; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultraviolet Therapy; Phototherapy; Therapeutics; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hoda M Rasheed, MD

  Cairo University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 21, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

EG (1)