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Role of Minoxidil in Alopecia Areata Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fractional CO2 laser
Derma pen
Niosome minoxidil
Minoxidil Topical Spray
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

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The study will include patients with alopecia areata

Exclusion Criteria:

  • Children below 18 years , pregnant and lactating women . patients with chronic hepatic, hematological disorders or immunocompromised patients.

patient recieved any treatment for alopecia areata in the last 3 months before the study.

patients with extensive types (alopecia totalis, universalis and surface area >50%).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Group 3

    Group 4

    Arm Description

    six sessions of fractional carbon dioxide laser every 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5%

    six sessions of microneedling evry 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5%

    15 patient of alopecia areata that will be treated by topical nanominoxidil for 3 months.

    15 patient of alopecia areata that will be treated by topical minoxidil 5% for 3 months

    Outcomes

    Primary Outcome Measures

    Regrowth scale
    0 score (regrowth < 10%) no response score (regrowth 11-25%) poor response score (regrowth 26-50%) fair response score (regrowth 51-75%) satisfactory response score (regrowth ≥ 75%) excellent response
    Mcdonald Hull and Norris Regrowth Scale (by trichoscope
    Grade 1 - Regrowth of vellus hair. Grade 2 - Regrowth of sparse pigmented terminal hair. Grade 3 - Regrowth of terminal hair with patches of alopecia with patches of alopecia 50-75% in SALT score. Grade 4 - Regrowth of terminal hair on scalp with patches of alopecia > 75% in SALT score.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 16, 2022
    Last Updated
    October 16, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05587257
    Brief Title
    Role of Minoxidil in Alopecia Areata Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata
    Official Title
    Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    February 1, 2024 (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

    5. Study Description

    Brief Summary
    Compare the clinical efficacy, and safety of transepidermal drug delivery of fractional CO2 laser versus microneedling followed by minoxidil 5% application for the treatment of alopecia areata. Evaluate the efficacy, and safety of minoxidil nanoparticles as a topical treatment of alopecia areata.
    Detailed Description
    Alopecia areata (AA) is the most common cause of non-scarring alopecia. (Hordinsky, 2013). Although many patients improve spontaneously or respond to standard therapy, in patients with more severe and refractory disease, management can be quite challenging (Messenger et al., 2012 and Kranseler and Sidbury, 2017). Corticosteroids either topical or intralesional are the most popular medications used to treat this condition. Other therapies such as topical minoxidil (MXD), anthralin, immunotherapy, systemic corticosteroids are also commonly used with variable success (Shumez et al., 2015). Patients treated with MXD 5% have significant hair growth than placebo. Minoxidil was more effective for patchy alopecia than other types of AA such as ophiasis and alopecia totalis. It was ineffective in alopecia universalis (El-Taib et al., 2017). In contrast, the incidence of adverse events associated with 10% MXD treatment was higher than with 5% MXD treatment. Therefore, new approaches are required to achieve both expected efficacy and safety (Oaku et al., 2022). The combination of non-ablative laser and topical MXD can be a good alternative therapy for AA patients, including alopecia totalis and alopecia universalis, without systemic and local side effects (Wang et al., 2019) According to follicle deposition and diffusion experiments, minoxidil nanoemulsions penetrated hair follicles 26 times more efficiently than standard treatment (Cardoso and Barradas, 2020). To the best our knowledge no previous research studied the effect of nanominoxidil solution in treatment of AA except in animal or compare transepidermal drug delivery versus topical nanominoxidil.

    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
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    six sessions of fractional carbon dioxide laser every 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5%
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    six sessions of microneedling evry 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5%
    Arm Title
    Group 3
    Arm Type
    Experimental
    Arm Description
    15 patient of alopecia areata that will be treated by topical nanominoxidil for 3 months.
    Arm Title
    Group 4
    Arm Type
    Active Comparator
    Arm Description
    15 patient of alopecia areata that will be treated by topical minoxidil 5% for 3 months
    Intervention Type
    Device
    Intervention Name(s)
    Fractional CO2 laser
    Other Intervention Name(s)
    Drug
    Intervention Description
    Each patient will receive 6 sessions 2 weeks apart, after the laser treatment, a topical 5% minoxidil tincture will immediately applied. All patients will advised not to use any other treatment during the study
    Intervention Type
    Device
    Intervention Name(s)
    Derma pen
    Other Intervention Name(s)
    Drug
    Intervention Description
    , will be treated by microneedling using dermapen ( automated Derma Pen, DR Pen Ultima A6, China) which under complete aseptic precaution with a cartridge containing 12 needles moved diagonally, vertically, and horizontally for 4-5 times in each direction with 1.5 mm depth and speed 4-5(new cartridge every session), the application has been extended 1-2 cm perilesionally. The pinpoint bleeding will be considered an endpoint. topical 5% minoxidil tincture will immediately applied. Each patient will receive 6 sessions 2 weeks apart.
    Intervention Type
    Drug
    Intervention Name(s)
    Niosome minoxidil
    Intervention Description
    The patient of alopecia areata will be treated by topical nanominoxidil preparation twice daily for 3 months with no other treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Minoxidil Topical Spray
    Intervention Description
    The patient of alopecia areata will be treated by topical minoxidil 5% preparation twice daily for 3 months with no other treatment.
    Primary Outcome Measure Information:
    Title
    Regrowth scale
    Description
    0 score (regrowth < 10%) no response score (regrowth 11-25%) poor response score (regrowth 26-50%) fair response score (regrowth 51-75%) satisfactory response score (regrowth ≥ 75%) excellent response
    Time Frame
    6 months
    Title
    Mcdonald Hull and Norris Regrowth Scale (by trichoscope
    Description
    Grade 1 - Regrowth of vellus hair. Grade 2 - Regrowth of sparse pigmented terminal hair. Grade 3 - Regrowth of terminal hair with patches of alopecia with patches of alopecia 50-75% in SALT score. Grade 4 - Regrowth of terminal hair on scalp with patches of alopecia > 75% in SALT score.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The study will include patients with alopecia areata Exclusion Criteria: Children below 18 years , pregnant and lactating women . patients with chronic hepatic, hematological disorders or immunocompromised patients. patient recieved any treatment for alopecia areata in the last 3 months before the study. patients with extensive types (alopecia totalis, universalis and surface area >50%).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Elsayed, Master
    Phone
    +20 1000520295
    Email
    Ahmed.alsaid@med.aun.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Role of Minoxidil in Alopecia Areata Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata

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