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

Primary Purpose

Alopecia Areata

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
fractional carbon dioxide laser alone
Triamcinolone Acetonide 10mg/mL
platelet rich plasma
vitamin D solution
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring fractional carbon dioxide laser

Eligibility Criteria

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

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.

Sites / Locations

  • Assiut University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

fractional carbon dioxide laser alone

fractional carbon dioxide laser and triamcinolone acetonide

fractional carbon dioxide laser and platelet rich plasma

fractional carbon dioxide laser and vitamin D solution

Arm Description

six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata

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)

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

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

Outcomes

Primary Outcome Measures

response rate
hair regrowth in each group in response to treatment (hair density ) expressed in follicles/ cm2

Secondary Outcome Measures

Full Information

First Posted
June 27, 2019
Last Updated
May 17, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04003376
Brief Title
Efficacy of Fractional CO2 Laser as a Mono- or Adjuvant Therapy for Alopecia Areata
Official Title
Efficacy of Fractional CO2 Laser Alone and as Transepidermal Drug Delivery for Different Modalities of Treatment in Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
fractional carbon dioxide laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fractional carbon dioxide laser alone
Arm Type
Active Comparator
Arm Description
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata
Arm Title
fractional carbon dioxide laser and triamcinolone acetonide
Arm Type
Experimental
Arm Description
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)
Arm Title
fractional carbon dioxide laser and platelet rich plasma
Arm Type
Experimental
Arm Description
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
Arm Title
fractional carbon dioxide laser and vitamin D solution
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
fractional carbon dioxide laser alone
Intervention Description
six sessions of fractional carbon dioxide laser will be done for alopecia areata lesions
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 10mg/mL
Intervention Description
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide
Intervention Type
Biological
Intervention Name(s)
platelet rich plasma
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
vitamin D solution
Intervention Description
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 Measure Information:
Title
response rate
Description
hair regrowth in each group in response to treatment (hair density ) expressed in follicles/ cm2
Time Frame
3 months after last session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azza Mahfouz, PHD
Phone
01001801039
Email
azzamahfouz@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa Bakr, PHD
Phone
01119988115
Email
radwabakr2011@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa Ghazally, MS
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa Ghazally, MS
Phone
01007224787
Email
alaaghazally@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24655364
Citation
Aksu Cerman A, Sarikaya Solak S, Kivanc Altunay I. Vitamin D deficiency in alopecia areata. Br J Dermatol. 2014 Jun;170(6):1299-304. doi: 10.1111/bjd.12980.
Results Reference
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PubMed Identifier
20115946
Citation
Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part II. Treatment. J Am Acad Dermatol. 2010 Feb;62(2):191-202, quiz 203-4. doi: 10.1016/j.jaad.2009.10.031.
Results Reference
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PubMed Identifier
28528395
Citation
Huang Y, Zhuo F, Li L. Enhancing hair growth in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors. Lasers Med Sci. 2017 Nov;32(8):1711-1718. doi: 10.1007/s10103-017-2232-8. Epub 2017 May 21.
Results Reference
background
PubMed Identifier
25260052
Citation
Issa MC, Pires M, Silveira P, Xavier de Brito E, Sasajima C. Transepidermal drug delivery: a new treatment option for areata alopecia? J Cosmet Laser Ther. 2015 Feb;17(1):37-40. doi: 10.3109/14764172.2014.967778. Epub 2014 Oct 16.
Results Reference
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Efficacy of Fractional CO2 Laser as a Mono- or Adjuvant Therapy for Alopecia Areata

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