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Evaluation of the efficacy of the co2 fractional laser on the treatment of dilated pores

Protocol summary

Summary
Study purpose: Efficacy of the co2 fractional laser on the treatment of dilated pores determination study design:phase2 clinical trial. Methodology: Target selection: Patients referring to Shohadaye Tajrish Educational Hospital a) Inclusion criteria:1)females between 18 and 50years of age Exclusion criteria included: 1)males 2)females younger than 18 years old 3)pregnancy and lactation 4)cosmetic procedures affecting the treatment area (e.g.,botulinum toxin, dermabrasion, chemical peeling, laser surgery, or face-lift) within the last 6months 5) oral isotretinoin within the last 6months 6) history of keloid formation Target sample size:30b) Study interventions: Patients were assigned to receive treatment on face with a fractional CO2 laser. c)Time of the intervention:3 treatment sessions with 1 month interval for each patient d)Study outcome: The evaluation both before each treatment session and 3months after the last one will be done with digital photography .Assessment of side effects (e.g. Pain, stinging, pruritus, redness, bulla, bleeding, crust formation ,hypopigmentation, hyperpigmentation, scar, atrophy)will be performed

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016032027109N1
Registration date: 2016-06-02, 1395/03/13
Registration timing: na

Last update:
Update count: 0
Registration date
2016-06-02, 1395/03/13
Registrant information
Name
Fahimeh Abdollahimajd
Name of organization / entity
Skin Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
fabdollahimajd@sbmu.ac.ir
Recruitment status
Not enough for processing
Funding source
Dermatology Research Center of Shahid Beheshti University of Medical Science
Expected recruitment start date
2007-12-01, 1386/09/10
Expected recruitment end date
2006-05-01, 1385/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of the co2 fractional laser on the treatment of dilated pores
Public title
Efficay of laser on dilated pores
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: females between 18 and 50years of age Exclusion criteria :males ;females younger than 18 year old; pregnancy and lactation; cosmetic procedures affecting the treatment area (e.g.,botulinum toxin ,dermabrasion, chemical peeling, laser surgery, or face-lift)within the last 6months;oral isotretinoin within the last 6months; history of keloid formation
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Skin Research Center,Shahid Beheshti University of Medical Science
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Postal code
Approval date
2015-06-25, 1394/04/04
Ethics committee reference number
IR.SBMU.RAM.REC.1394.4/4

Health conditions studied

1

Description of health condition studied
dilated pores
ICD-10 code
L98.8
ICD-10 code description
Other specified disorders of skin and subcutaneous tissue

Primary outcomes

1

Description
pores improvement
Timepoint
before treatment_before each session_3month after the last session
Method of measurement
improvment percentage_comparing digital photoghraphes by dermatologist

Secondary outcomes

1

Description
side effects(pain-burning and stinging-erythem-edema-bulla-bleeding-crust formation-hypopigmentation-hyperpigmentation-scar-atrophy)
Timepoint
one week after each treatment session
Method of measurement
patient evaluation with questionnaire-dermatologist evaluation

Intervention groups

1

Description
Topical anesthetic gel is applied to both sides of face and left for 30minutes. The patient's eyes are covered with a shield during the entire procedure. Patients are assigned to receive treatment with a fractional Co2 Laser on face ;which is focused to a spot size of approximately 120 micrometer in diameter ,the pulse duration of 10 milliseconds and pulse energy varies from 5 to 70mJ .Three treatment sessions with 1 month interval for each patient will be done.The evaluation before each treatment session and 3months after the last one will be done with digital photography .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada-E- Tajrish Educational Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science-Skin Research Center
Full name of responsible person
Dr Parviz Toosi
Street address
Iran, Tehran, Velenjak St. , Shahid Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Science-Skin Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Elmira Asadi
Position
Assistant Resident of Dermatology
Other areas of specialty/work
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
asadielmira8@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
DR Fahimeh Abdollahi Majd
Position
Assistant Professor of Dermatology
Other areas of specialty/work
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
FABDOLLAHIMAJD@YAHOO.COM
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Elmira Asadi
Position
Assistant Resident of Dermatology
Other areas of specialty/work
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
asadielmira8@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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