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Excimer Light and Topical Steroid in Treatment of Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
topical steroid and 308nm-Excimer light therapy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged 16-40 years,
  • Good general health,
  • A clinical diagnosis of multiple Alopecia Areata of the scalp.
  • Hair loss <25 percent of the total scalp.
  • No use of drugs or hair care products influencing hair growth in the last 2 months.

Exclusion Criteria:

  • Other causes of hair loss (like endocrine or immunological diseases).
  • Skin disease in the treatment area.
  • Pregnant or lactating patients.
  • Hair transplantation history.
  • Photosensitivity history.
  • Malignant tumor history.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    light therapy twice weekly

    light therapy once weekly

    Arm Description

    15 or half of the patients with three patches of Alopecia Areata on the scalp the first patch will be treated by 308nm Excimer light twice weekly and topical steroid twice daily the second patch will be treated by topical steroid twice daily. the third patch will be left as a control.

    15 or half of the patients with three patches of Alopecia Areata on the scalp the first patch will be treated by 308nm Excimer light once weekly and topical steroid twice daily. the second patch will be treated by topical steroid twice daily. the third patch will be left as a control.

    Outcomes

    Primary Outcome Measures

    Severity of ALopecia Tool score
    The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40 percent (0.40), right side = 18 percent (0.18), left side = 18 percent (0.18) and the posterior aspect = 24 percent (0.24). Percentage of hair loss in any of the four areas was multiplied by the percentage of the scalp covered in that area. The Severity of Alopecia Tool score is the sum of the percentage of hair loss in all the areas mentioned above.[10]
    digital photographs
    using identical camera settings, lighting, patient positioning and background.
    The hair regrowth in the patches of alopecia
    0 = no hair regrowth, = 1-25percent hair regrowth, = 26-50percent hair regrowth, = 51-75percent hair regrowth, and = 76-100 percent hair regrowth.
    Dermoscopic evaluation
    Dermoscopy will be used to analyze the change in the count of hair at intervals of 4 weeks. The number of hair (total, vellus, and terminal hairs) will be calculated by dermoscopy .
    A patient satisfaction score
    0 to 25percent change = not satisfied, 26 to 50percent = mildly satisfied, 51 to 75percent = moderately satisfied, 76 to 100percent = very satisfied
    adverse effects
    Any encountered adverse effects in terms of pain, erythema, edema and crusts will be recorded.
    dermoscopic evaluation
    The mean diameter of hair will be recorded for analysis.
    dermoscopic evaluation
    diameter of hair will be measured

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2021
    Last Updated
    March 10, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04793945
    Brief Title
    Excimer Light and Topical Steroid in Treatment of Alopecia Areata
    Official Title
    The Efficacy of Combining 308 Nm-Excimer Light and Topical Steroid in the Treatment of Alopecia Areata
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    April 1, 2022 (Anticipated)
    Study Completion Date
    September 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Alopecia areata is a polygenic autoimmune disease causing hair loss, particularly during the anagen phase of hair growth This condition has a lifetime risk of about 2.1% of the world population and the cumulative incidence seems to rise linearly with age . Patchy non scarring hair loss on the scalp is the most common clinical presentation, although it can also occur elsewhere . In addition to patchy Alopecia Areata , a more severe form, alopecia totalis , presents with diffuse hair loss across the scalp. In the most severe form, alopecia universalis , hair loss occurs on all areas of the body, including the beard, eyelashes, and extremities .
    Detailed Description
    Alopecia Areata can have a large impact on patients' quality of life, causing both cosmetic and psychosocial distress. Studies on the impact of hair loss have shown high levels of self-consciousness, jealousy, embarrassment, depression, introversion, and decreased self-esteem . Alopecia Areata can occur at any age, but it is most common among young and middle-aged people . Both sexes are equally affected. Several environmental factors have been suggested as triggering Alopecia Areata, including infection, drugs, trauma, and stress. Thyroid autoimmune disease, atopy, and vitiligo are commonly associated. Diverse physical or psychological insults may trigger the episodes of Alopecia Areata, but there is no evidence that they influence prognosis. Etiology of Alopecia Areata is not completely understood, and the majority of evidence suggests that genetically predisposed individuals, when exposed to an unknown trigger, develop a predominantly autoimmune reaction, leading to acute hair loss. Although many patients improve spontaneously or respond to standard therapy, treatment can be quite challenging in those with more severe and refractory disease . Topical corticosteroids are often the first line of treatment for mild patchy alopecia, with the underlying mechanism being containment of inflammation and hastening of the recovery of damaged hair follicles . Additionally, corticosteroids may be delivered via intralesional injection with slightly better effects (63% with complete regrowth within 4 months in one study . However, this method cannot be used for rapidly progressing variants and does not prevent hair loss at other sites . Furthermore, both topical and intralesional steroids increase the risk of cutaneous atrophy at the site of treatment, and intralesional steroids may decrease bone mineral density . With the development of new technologies, more and more lasers or lamps have been used to treat alopecia, such as ultraviolet , Excimer laser/lamp , low-level laser , erbium-glass laser, thulium laser , and carbon dioxide laser . Individual researchers have been considering 308-nm Excimer lamp to be used for treating Alopecia Areata by inducing apoptosis of T lymphocytes, but the effective rates had differences in studies . Excimer laser using high-dose monochromatic UV radiation can trigger apoptosis and induce immunological suppression through altering cytokine production such as interleukin-4, interleukin-10, prostaglandin E2, platelet-activating factor, and cis-urocanic acid .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alopecia Areata

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    patients with three patches of Alopecia Areata the first patch will be treated by topical steroid and Excimer light the second patch will be treated by topical steroid only the third patch will be left as a control
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    light therapy twice weekly
    Arm Type
    Active Comparator
    Arm Description
    15 or half of the patients with three patches of Alopecia Areata on the scalp the first patch will be treated by 308nm Excimer light twice weekly and topical steroid twice daily the second patch will be treated by topical steroid twice daily. the third patch will be left as a control.
    Arm Title
    light therapy once weekly
    Arm Type
    Active Comparator
    Arm Description
    15 or half of the patients with three patches of Alopecia Areata on the scalp the first patch will be treated by 308nm Excimer light once weekly and topical steroid twice daily. the second patch will be treated by topical steroid twice daily. the third patch will be left as a control.
    Intervention Type
    Combination Product
    Intervention Name(s)
    topical steroid and 308nm-Excimer light therapy
    Intervention Description
    applying topical steroid in combination with 308nm-Excimer light therapy to treat Alopecia Areata
    Primary Outcome Measure Information:
    Title
    Severity of ALopecia Tool score
    Description
    The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40 percent (0.40), right side = 18 percent (0.18), left side = 18 percent (0.18) and the posterior aspect = 24 percent (0.24). Percentage of hair loss in any of the four areas was multiplied by the percentage of the scalp covered in that area. The Severity of Alopecia Tool score is the sum of the percentage of hair loss in all the areas mentioned above.[10]
    Time Frame
    9months
    Title
    digital photographs
    Description
    using identical camera settings, lighting, patient positioning and background.
    Time Frame
    9months
    Title
    The hair regrowth in the patches of alopecia
    Description
    0 = no hair regrowth, = 1-25percent hair regrowth, = 26-50percent hair regrowth, = 51-75percent hair regrowth, and = 76-100 percent hair regrowth.
    Time Frame
    9months
    Title
    Dermoscopic evaluation
    Description
    Dermoscopy will be used to analyze the change in the count of hair at intervals of 4 weeks. The number of hair (total, vellus, and terminal hairs) will be calculated by dermoscopy .
    Time Frame
    9months
    Title
    A patient satisfaction score
    Description
    0 to 25percent change = not satisfied, 26 to 50percent = mildly satisfied, 51 to 75percent = moderately satisfied, 76 to 100percent = very satisfied
    Time Frame
    9months
    Title
    adverse effects
    Description
    Any encountered adverse effects in terms of pain, erythema, edema and crusts will be recorded.
    Time Frame
    9months
    Title
    dermoscopic evaluation
    Description
    The mean diameter of hair will be recorded for analysis.
    Time Frame
    9months
    Title
    dermoscopic evaluation
    Description
    diameter of hair will be measured
    Time Frame
    9months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged 16-40 years, Good general health, A clinical diagnosis of multiple Alopecia Areata of the scalp. Hair loss <25 percent of the total scalp. No use of drugs or hair care products influencing hair growth in the last 2 months. Exclusion Criteria: Other causes of hair loss (like endocrine or immunological diseases). Skin disease in the treatment area. Pregnant or lactating patients. Hair transplantation history. Photosensitivity history. Malignant tumor history.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    eman R mohamed hofny, professor
    Phone
    01005298992
    Ext
    002
    Email
    e_riad@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    yasmeen M tawfik mhany, PHD
    Phone
    01006033331
    Ext
    002
    Email
    dr.yasminmostawfik@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fatma m zidan, student
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    one year
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    Excimer Light and Topical Steroid in Treatment of Alopecia Areata

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