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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003376
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
A Ghazally, Assiut University

Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE July 26, 2019
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
response rate [ Time Frame: 3 months after last session ]
hair regrowth in each group in response to treatment (hair density ) expressed in follicles/ cm2
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Fractional CO2 Laser as a Mono- or Adjuvant Therapy for Alopecia Areata
Official Title  ICMJE Efficacy of Fractional CO2 Laser Alone and as Transepidermal Drug Delivery for Different Modalities of Treatment in Alopecia Areata
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.

Detailed Description

The onset and progression of alopecia areata are unpredictable. Significant variations in the clinical presentation of alopecia areata have been observed, ranging from small, well-circumscribed patches of hair loss to a complete absence of body and scalp hair.

Although many patients improve spontaneously or respond to standard therapy, treatment can be quite challenging in those with more severe and refractory disease.

Recent advances in the understanding of alopecia areata pathophysiology hold promise for better treatments in the future.

Corticosteroids either topical or intralesional are the most popular drugs for the treatment of this disease. Other therapies like topical minoxidil, anthralin, immunotherapy, systemic corticosteroids, cyclosporine and Psoralen with Ultraviolet-A Light therapy are also commonly used with varying success.

Various lasers have been suggested in recent studies to treat alopecia areata . The effect of 308-nm excimer laser was the most studied, while others, including neodymium-doped yttrium aluminum garnet, erbium:glass laser, fractional carbon dioxide laser, and low-level laser therapy, have also been assessed.

Despite the nascent state of research on lasers as a treatment option for alopecia areata , there have been a great deal of promising results. It is possible for lasers to become the mainstay treatment option of alopecia areata .

It was suggested that ablative fractional lasers may exert its effect through: induction of moderate inflammation to promote anagen entry and creation of channel pathways for topically applied medications they grant access to dermal structures such as hair follicles and cutaneous vasculature. Also, creation of a wound by the ablative fractional laser may stimulate stem cell populations to produce a hair shaft and progress through all stages of the hair follicle cycle.

Majid et al, investigated the efficacy and safety of the combination of fractional carbon dioxide followed by topical triamcinolone acetonide application in ten patients with resistant alopecia areata. Only eight patients completed the study. Seven of them had complete recovery of the treated area. One patient however did not show good response. No significant adverse effects were noted in any of the patients.

The role of platelet rich plasma in promoting hair survival and growth has been demonstrated both in vitro and in vivo. The activation of platelet α granules releases numerous growth factors, including transforming growth factor , platelet derived growth factor, vascular endothelial growth factor, epidermal growth factor, insulin-like growth factor, and interleukin-1. It is proposed that these growth factors may act on stem cells in the bulge area of the follicles, stimulating the development of new follicles and promoting neovascularization. platelet rich plasma has been found to benefit in hair growth in alopecia areata. Intralesional injections of platelet rich plasma were found to increase hair regrowth significantly compared with triamcinolone acetonide or placebo.

Vitamin D 1, 25-dihydroxycholecalciferol [1, 25(OH)/2 D3] is the biologic active form of the vitamin D3. Vitamin D has a multitude of biologic effects interacting with the innate and adaptive immune system, mainly leading to its downregulation. It regulates the differentiation of B cells, T cells, dendritic cells, and the expression of Toll-like receptors. There is growing evidence that vitamin D may help in several autoimmune diseases like multiple sclerosis and type I diabetes mellitus, lupus, and rheumatoid arthritis.

The relation between vitamin D levels and the development of alopecia areata and whether vitamin D supplementation helps in the treatment of alopecia areata represent an attractive area of research. Recent studies suggest that there is deficiency of serum vitamin D and reduced vitamin D receptor expression in the affected hair follicles in alopecia areata patients, the results of which may prove that vitamin D is a safe and helpful choice in alopecia areata treatment.

To the best our knowledge no previous research studied the effect of vitamin D solution in treatment of alopecia areata.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: fractional carbon dioxide laser alone
    six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata
    Intervention: Device: fractional carbon dioxide laser alone
  • 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)
    Interventions:
    • Device: fractional carbon dioxide laser alone
    • Drug: Triamcinolone Acetonide 10mg/mL
  • 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
    Interventions:
    • Device: fractional carbon dioxide laser alone
    • Biological: 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
    Interventions:
    • Device: fractional carbon dioxide laser alone
    • Drug: vitamin D solution
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Azza Mahfouz, PHD 01001801039 azzamahfouz@yahoo.com
Contact: Radwa Bakr, PHD 01119988115 radwabakr2011@hotmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003376
Other Study ID Numbers  ICMJE CO2LASERAA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party A Ghazally, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alaa Ghazally, MS Assiut University
PRS Account Assiut University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP