NCT04320160

Brief Summary

Vitiligo is considered the most common chronic depigmentation disorder that affects around 0.5 -2% of the world population . In Africa , its prevelance is around 0.4% and 1.22 % in Assiut . Treatment of vitiligo includes medical topical and systemic immune -suppressants ,phototherapy and surgical modalities .Despite the numerous treatment options , the treatment of choice is still controversial as the response is variable , unsatisfactory ,and requires a prolonged course. Therefore, new therapeutic approaches are required . Platelet -rich plasma (PRP) is a treatment modality which has been used over the last several years in various medical and surgical fields . It is composed of high concentration of platelets , several growth factors and plasma proteins such as fibrin, fironectin ,vitronectin .This is hypothesized to stimulate keratinocytes and fibroblasts proliferation . Another treatment modality is the fractional CO2 (Fr: CO2) laser .There are theories that fractional CO2 laser causes release of various types of cytokines and growth factors that can stimulate migration of melanocytes and act as mitogens for melanogenesis . Melanogenesis is a complex process with involvement of multiple signaling pathways. Therefore, there have been extensive efforts to reveal the molecular mechanisms that control melanogenesis as the main step for treating hypopigmentary skin disorders . There is yet very limited histopathological and molecular information about how the signaling networks are involved in the initiation , progression and also treatment of vitiligo disease.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

March 19, 2020

Last Update Submit

March 23, 2020

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • melanocyte cell quantification by light microscope

    Punch biopsy specimens will be stained by special immunohistochemical stain of Melan A antibody marker then counting melanocyte cells per field in five non overlapping fields using NIKON camera attached to a light microscope

    1 year

Secondary Outcomes (1)

  • Mean improvement score by physician (MISP)

    1 year

Study Arms (3)

Positive control group

NO INTERVENTION

Include the thirty patients before any treatment

PRP group

ACTIVE COMPARATOR

Include fifteen patients that will recieve PRP sessions .Patients will receive six treatment sessions with one month interval for 6 months and will be followed up after 6 months.

Procedure: Platelet rich plasma

Fractional CO2 group

ACTIVE COMPARATOR

Include fifteen patients that will recieve FR: CO2 laser sessions.Patients will receive six treatment sessions with one month interval for 6 months and will be followed up after 6 months.

Procedure: Fractional CO2 laser

Interventions

Platelet rich plasmaPROCEDURE

Eight milliliters of blood sample will be aspirated from the patient's peripheral vein, and the sample will be centrifuged at 1,500 rpm for 5 minutes. A 30-G needle will be used for superficial intradermal (ID) microinjections (0.1 mL per injection and space about 1 cm apart)

Also known as: PRP
PRP group
Fractional CO2 laserPROCEDURE

Fifteen lesions will be treated by Fr: CO2 laser (10,600 nm; KES Corporation, Beijing, China). Scanner spot size will be adjusted based on the lesion size. Density selected will be 0.6 in the static mode. Two passes with minimal overlap will be delivered. The laser will be applied to the vitiligo lesion and over a thin rim of healthy skin

Also known as: Fr: CO2 laser
Fractional CO2 group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 20-60 years old
  • Avoid using any other treatment modalities for vitiligo during the course of the study

You may not qualify if:

  • Pregnant and lactating women
  • local medications or laser therapy one month prior to the study
  • bleeding disorders
  • history of keloid formation
  • photosensitivity
  • seizure disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Kadry M, Tawfik A, Abdallah N, Badawi A, Shokeir H. Platelet-rich plasma versus combined fractional carbon dioxide laser with platelet-rich plasma in the treatment of vitiligo: a comparative study. Clin Cosmet Investig Dermatol. 2018 Nov 8;11:551-559. doi: 10.2147/CCID.S178817. eCollection 2018.

    PMID: 30510437BACKGROUND

  • Abdel-Hafez K, Abdel-Aty MA, Hofny ER. Prevalence of skin diseases in rural areas of Assiut Governorate, Upper Egypt. Int J Dermatol. 2003 Nov;42(11):887-92. doi: 10.1046/j.1365-4362.2003.01936.x.

    PMID: 14636205BACKGROUND

  • Kim HJ, Hong ES, Cho SH, Lee JD, Kim HS. Fractional Carbon Dioxide Laser as an "Add-on" Treatment for Vitiligo: A Meta-analysis with Systematic Review. Acta Derm Venereol. 2018 Feb 7;98(2):180-184. doi: 10.2340/00015555-2836.

    PMID: 29110015BACKGROUND

  • Abuaf OK, Yildiz H, Baloglu H, Bilgili ME, Simsek HA, Dogan B. Histologic Evidence of New Collagen Formulation Using Platelet Rich Plasma in Skin Rejuvenation: A Prospective Controlled Clinical Study. Ann Dermatol. 2016 Dec;28(6):718-724. doi: 10.5021/ad.2016.28.6.718. Epub 2016 Nov 23.

    PMID: 27904271BACKGROUND

  • Calautti E, Li J, Saoncella S, Brissette JL, Goetinck PF. Phosphoinositide 3-kinase signaling to Akt promotes keratinocyte differentiation versus death. J Biol Chem. 2005 Sep 23;280(38):32856-65. doi: 10.1074/jbc.M506119200. Epub 2005 Jul 21.

    PMID: 16036919BACKGROUND

  • Bishnoi A, Parsad D. Clinical and Molecular Aspects of Vitiligo Treatments. Int J Mol Sci. 2018 May 18;19(5):1509. doi: 10.3390/ijms19051509.

    PMID: 29783663BACKGROUND

  • Kumar R, Parsad D, Kanwar AJ, Kaul D. Altered levels of Ets-1 transcription factor and matrix metalloproteinases in melanocytes from patients with vitiligo. Br J Dermatol. 2011 Aug;165(2):285-91. doi: 10.1111/j.1365-2133.2011.10324.x.

    PMID: 21428970BACKGROUND

  • Li L, Wu Y, Li L, Sun Y, Qiu L, Gao XH, Chen HD. Triple combination treatment with fractional CO2 laser plus topical betamethasone solution and narrowband ultraviolet B for refractory vitiligo: a prospective, randomized half-body, comparative study. Dermatol Ther. 2015 May-Jun;28(3):131-4. doi: 10.1111/dth.12202. Epub 2015 Mar 5.

    PMID: 25753514BACKGROUND

  • Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.

    PMID: 15216537BACKGROUND

  • Picardo M, Dell'Anna ML, Ezzedine K, Hamzavi I, Harris JE, Parsad D, Taieb A. Vitiligo. Nat Rev Dis Primers. 2015 Jun 4;1:15011. doi: 10.1038/nrdp.2015.11.

    PMID: 27189851BACKGROUND

  • Rodrigues M, Ezzedine K, Hamzavi I, Pandya AG, Harris JE; Vitiligo Working Group. Current and emerging treatments for vitiligo. J Am Acad Dermatol. 2017 Jul;77(1):17-29. doi: 10.1016/j.jaad.2016.11.010.

    PMID: 28619557BACKGROUND

  • Wrotniak M, Bielecki T, Gazdzik TS. Current opinion about using the platelet-rich gel in orthopaedics and trauma surgery. Ortop Traumatol Rehabil. 2007 May-Jun;9(3):227-38. English, Polish.

    PMID: 17721419BACKGROUND

  • Zhang Y, Cai Y, Shi M, Jiang S, Cui S, Wu Y, Gao XH, Chen HD. The Prevalence of Vitiligo: A Meta-Analysis. PLoS One. 2016 Sep 27;11(9):e0163806. doi: 10.1371/journal.pone.0163806. eCollection 2016.

    PMID: 27673680BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Amal T. ELghait, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reham I. ElGibaly, researcher

CONTACT

01003639560dr.reham.elgibaly@hotmail.com

Dalia A. El-Gamal, Professor

CONTACT

01003343040delgamal197462@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 24, 2020

Study Start

August 1, 2020

Primary Completion

February 28, 2021

Study Completion

October 24, 2022

Last Updated

March 24, 2020

Record last verified: 2020-03