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Efficacy of Fractional CO2 Laser as a Mono- or Adjuvant Therapy for Alopecia Areata

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ClinicalTrials.gov Identifier: NCT04003376
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
A Ghazally, Assiut University

Brief Summary:

Alopecia areata is a non-scarring hair loss disorder that affects both sexes equally. Incidence of the disease varies for different populations and in different studies, with global incidence ranging from 0.57% to 3.8%.

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. Environmental triggers, including viral or bacterial infections, along with autoimmune disorders, seem to play a major role in the development of alopecia areata.


Condition or disease Intervention/treatment Phase
Alopecia Areata Device: fractional carbon dioxide laser alone Drug: Triamcinolone Acetonide 10mg/mL Biological: platelet rich plasma Drug: vitamin D solution Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Fractional CO2 Laser Alone and as Transepidermal Drug Delivery for Different Modalities of Treatment in Alopecia Areata
Estimated Study Start Date : July 2, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: fractional carbon dioxide laser alone
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata
Device: fractional carbon dioxide laser alone
six sessions of fractional carbon dioxide laser will be done for alopecia areata lesions

Experimental: fractional carbon dioxide laser and triamcinolone acetonide
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide (10mg/ml)
Device: fractional carbon dioxide laser alone
six sessions of fractional carbon dioxide laser will be done for alopecia areata lesions

Drug: Triamcinolone Acetonide 10mg/mL
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide

Experimental: fractional carbon dioxide laser and platelet rich plasma
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of autologous platelet rich plasma
Device: fractional carbon dioxide laser alone
six sessions of fractional carbon dioxide laser will be done for alopecia areata lesions

Biological: platelet rich plasma
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of autologous platelet rich plasma

Experimental: fractional carbon dioxide laser and vitamin D solution
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of vitamin D solution
Device: fractional carbon dioxide laser alone
six sessions of fractional carbon dioxide laser will be done for alopecia areata lesions

Drug: vitamin D solution
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of vitamin D solution




Primary Outcome Measures :
  1. response rate [ Time Frame: 3 months after last session ]
    hair regrowth in each group in response to treatment (hair density ) expressed in follicles/ cm2



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with refractory alopecia areata above 10 years old

Exclusion Criteria:

  • Alopecia totalis or alopecia universalis.
  • Patients with alopecia other than alopecia areata.
  • Patients younger than 10 years.
  • Pregnant and lactating females.
  • Patients with history of hypertrophic scars or keloid formation.
  • Patients with active infection at the site of the lesion.
  • Patients with blood disorders and platelet abnormalities and chronic liver disease.
  • Patients using anticoagulation therapy and antiplatelet agents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003376


Contacts
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Contact: Azza Mahfouz, PHD 01001801039 azzamahfouz@yahoo.com
Contact: Radwa Bakr, PHD 01119988115 radwabakr2011@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Alaa Ghazally, MS Assiut University

Publications:
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Responsible Party: A Ghazally, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04003376     History of Changes
Other Study ID Numbers: CO2LASERAA
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by A Ghazally, Assiut University:
fractional carbon dioxide laser

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions
Vitamins
Vitamin D
Ergocalciferols
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action