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Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultraviolet A (UVA)
Triamcinolone Acetonide
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia, Areata, Phototherapy, Phototoxic, Ultraviolet A, Randomized controlled trial, Interferon gamma, Transforming growth factor beta-1, Insulin like growth factor-1

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dermatology department - faculty of medicine- Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phototherapeutic

Conventional therapy

Arm Description

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.

One monthly injections of intralesional potent corticosteroids

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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-γ, IGF-1 and TGF-Beta1
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.

Full Information

First Posted
March 12, 2012
Last Updated
April 5, 2014
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT01559584
Brief Title
Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata
Official Title
A Clinical and Immunological Study of Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia, Areata, Phototherapy, Phototoxic, Ultraviolet A, Randomized controlled trial, Interferon gamma, Transforming growth factor beta-1, Insulin like growth factor-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phototherapeutic
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
One monthly injections of intralesional potent corticosteroids
Intervention Type
Radiation
Intervention Name(s)
ultraviolet A (UVA)
Intervention Description
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 Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
One monthly injections of intralesional triamcinolone acetonide
Primary Outcome Measure Information:
Title
Treatment success
Description
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.
Time Frame
After six months from onset of treatment
Secondary Outcome Measure Information:
Title
Tissue cytokines response to therapy
Description
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
Time Frame
At early hair regrowth, but no later than three months of treatment onset, in case of failed hair regrowth
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Adverse events will be meticulously monitored all through the study, including hypo/hyper pigmentation, severe erythema, itching or burning sensation.
Time Frame
After six months from onset of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoda M Rasheed, MD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nermin El-Eishi, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vanessa G Hafez, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Solwan I Elsamanoudy, MBBCh
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rehab A Hegazy, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olfat G Shaker, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology department - faculty of medicine- Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
30411986
Citation
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.
Results Reference
derived

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Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata

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