1. Home
  2. Approved trials
  3. » فارسی

Evaluation of the effectiveness of co2 fractional laser with Platelet-Rich Plasma (PRP) and excimer lamp in comparison with co2 fractional laser with local tacrolimus and excimer lamp in patients with vitiligo

Protocol summary

Study aim
Determining the effectiveness of fractional co2 laser with Platelet-Rich Plasma (PRP) and excimer lamp in comparison with fractional co2 laser with local tacrolimus and excimer lamp in patients with vitiligo referred to Afzalipour Hospital in Kerman
Design
Clinical trial, with parallel, double-blind, randomized, single-phase groups on 36 patients. A table of numbers was used for randomization.
Settings and conduct
Patients in both groups receive three sessions of CO2 fractional laser at one-month intervals and an excimer lamp twice a week for a maximum of 12 weeks. In addition to laser injection, patients in group A use PRP injection and patients in group B use 0.1% tacrolimus ointment. Burning, itching, dryness, redness, flushing, scaling telangiectasia, secondary infection, and type of repigmentation are assessed by a physician who does not know the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years of age with vitiligo who have not received any treatment for vitiligo for 3 months prior to enrollment Exclusion criteria: Uncontrolled systemic diseases, renal failure, history of allergy to calcineurin inhibitors and macrolides, Unstable vitiligo, age under 18, segmental vitiligo, involvement of more than 20% of the skin surface, history of autoimmune disease and use Other treatments, patient with Koebner-positive history, history of colloid and pregnancy and lactation
Intervention groups
For group A patients, in addition to excimer laser and CO2, PRP injection is performed monthly. Group B patients are treated with 0.1% tacrolimus ointment on the skin twice a day from the next day.
Main outcome variables
Burning, itching, dryness, redness, flushing, scaling telangiectasia, secondary infection and type of repigmentation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210125050139N1
Registration date: 2021-07-18, 1400/04/27
Registration timing: registered_while_recruiting

Last update: 2021-07-18, 1400/04/27
Update count: 0
Registration date
2021-07-18, 1400/04/27
Registrant information
Name
Saleh Solhjou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3424 0219
Email address
saleh.s1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of co2 fractional laser with Platelet-Rich Plasma (PRP) and excimer lamp in comparison with co2 fractional laser with local tacrolimus and excimer lamp in patients with vitiligo
Public title
Efficacy of fractional co2 laser with PRP in patients with vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from vitiligo Age over 18 years They have not received any treatment for vitiligo for 3 months before enrollment Among the patients referred to Afzalipour Hospital, Besat Clinic and Dermatology Center The diagnosis is made clinically by a dermatologist Confirmation of the disease by means of examination with a Wood lamp
Exclusion criteria:
Uncontrolled systemic diseases renal failure history of allergy to calcineurin inhibitors and macrolides age under 18 segmental vitiligo involvement of more than 20% of the skin surface history of autoimmune disease and use of other treatments patient With a positive Coubern history history of colloid and pregnancy and lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 18
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization was done using minitab 16 software (Mini Tab Inc.)
Blinding (investigator's opinion)
Triple blinded
Blinding description
this is a triple-blind study for outcome assessor , patients and analyzor.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Ebne Sina Ave., Tahmasb Abad Blvd.
City
Kerman
Province
Kerman
Postal code
761614111
Approval date
2021-02-13, 1399/11/25
Ethics committee reference number
IR.KMU.AH.REC.1399.165

Health conditions studied

1

Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo

Primary outcomes

1

Description
Lesion area
Timepoint
at base line and 1, 2, 3, 4, 5 and 6 months later
Method of measurement
Measure the diameters of the depigmented lesion using a ruler

2

Description
disease activity
Timepoint
at base line and 1, 2, 3, 4, 5 and 6 months later
Method of measurement
Measurement of disease activity based on VIDA SCORE

3

Description
percentage of improvement
Timepoint
at base line and 1, 2, 3, 4, 5 and 6 months later
Method of measurement
By clinical examination of the lesion and measuring the percentage of lesion healing compared to the primary lesion

Secondary outcomes

1

Description
Erythema
Timepoint
at base line and 1, 2, 3, 4, 5 and 6 months later
Method of measurement
by physical examination and classification of the severity of adverse effects to mild , moderate and severe

2

Description
scaling
Timepoint
at base line and 1, 2, 3, 4, 5 and 6 months later
Method of measurement
by physical examination and classification of the severity of adverse effects to mild , moderate and severe

3

Description
pruritis
Timepoint
at base line and 1, 2, 3, 4, 5 and 6 months later
Method of measurement
by physical examination and classification of the severity of adverse effects to mild , moderate and severe

4

Description
secondary
Timepoint
at base line and 1, 2, 3, 4, 5 and 6 months later
Method of measurement
With clinical examination of the lesions and the presence of signs of infection such as purulent discharge and hotness

Intervention groups

1

Description
Intervention group: Co2 fractional laser (; Italy; Energy, 100mj; density, 100 / cm2; 2 passes DEKA) with, dwell time: 400, power: 6 w, dot mode spacing: 550. 3 sessions with one month intervals and lamp excimer (Medflash II, Italy; 308nm) twice a week for a maximum of 12 weeks starting at 0.5 J / cm2. In this group, in addition after the PRP preparation, we inject 0.1 cc of the solution into the patient's blood at a distance of 1 cm.
Category
Treatment - Devices

2

Description
Control group: Co2 fractional laser (; Italy; Energy, 100mj; density, 100 / cm2; 2 passes DEKA) with, dwell time: 400, power: 6 w, dot mode spacing: 550 Three sessions with one month intervals and lamp excimer (Medflash II, Italy; 308nm) twice a week for a maximum of 12 weeks starting at 0.5 J / cm2. In this group, in addition to this topical cream Tacrolimus 0.1% of Tehran Shimi Pharmaceutical Company is used twice a day for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Maryam Khalili
Street address
Imam high way, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
maryam_khalili36@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Ebne sina Aveue, Jahad Blvd
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Khalili
Position
Assistant professor of dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam high way, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
761691391
Phone
+98 34 3132 8328
Email
maryam_khalili36@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Khalili
Position
Assistant professor of dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam high way, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
761691391
Phone
+98 34 3132 8328
Email
maryam_khalili36@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Khalili
Position
Assistant professor of dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam high way, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
761691391
Phone
+98 34 3132 8328
Email
maryam_khalili36@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...