Efficacy of Fractional CO2 Laser as a Mono- or Adjuvant Therapy for Alopecia Areata
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2019
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2019
CompletedFirst Posted
Study publicly available on registry
July 1, 2019
CompletedStudy Start
First participant enrolled
July 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMay 19, 2020
May 1, 2020
1.9 years
June 27, 2019
May 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate
hair regrowth in each group in response to treatment (hair density ) expressed in follicles/ cm2
3 months after last session
Study Arms (4)
fractional carbon dioxide laser alone
ACTIVE COMPARATORsix sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata
fractional carbon dioxide laser and triamcinolone acetonide
EXPERIMENTALsix 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)
fractional carbon dioxide laser and platelet rich plasma
EXPERIMENTALsix 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
fractional carbon dioxide laser and vitamin D solution
EXPERIMENTALsix 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
six sessions of fractional carbon dioxide laser will be done for alopecia areata lesions
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide
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
Eligibility Criteria
You may qualify if:
- patients with refractory alopecia areata above 10 years old
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University Hospital
Asyut, Egypt
Related Publications (4)
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.
PMID: 24655364BACKGROUNDAlkhalifah 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.
PMID: 20115946BACKGROUNDHuang 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.
PMID: 28528395BACKGROUNDIssa 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.
PMID: 25260052BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alaa Ghazally, MS
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
June 27, 2019
First Posted
July 1, 2019
Study Start
July 26, 2019
Primary Completion
July 1, 2021
Study Completion
July 1, 2022
Last Updated
May 19, 2020
Record last verified: 2020-05