Protocol summary

Summary
Objectives: to compare the efficacy of retinoic acid 5% peeling with microdermabrasion and microdermabrasion with placebo for treatment of photoaging. Design: non randomized, single blind, clinical trial. Setting and conduct: in Alzahra hospital and Sedighe Tahere research center, eligible patients receive microdermabrasion on total face. This device abrade epiderm and superficial derm by aluminum oxide crystals and refer to Zagromed Company. Then the right side of face received retinoic acid 5% cream and the left side received placebo that was made by base of peeling cream. Treatment will be done in three sessions by one month interval. Outcome measures will be assessed by the use of serial photography at baseline, two weeks, one month, two months and four months after treatment, by two independent dermatologists. Inclusion criteria: informed consent for participation, no sensitivity to retinoic acid compounds, no treating for photoaging for at least three months before participation in study. Exclusion criteria: no using drug regularly, no referring regularly, discontinuing intervention, using other treatment modality within study. Intervention: right side of face receives microdermabrasion with retinoic acid 5% peeling and the left side receives microdermabrasion with placebo. Main outcome measures: improvement in photoaging assessed by two independent dermatologists by means of serial photography.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121112782N8
Registration date: 2016-02-07, 1394/11/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Isfahan university of medical sciences
Expected recruitment start date
2014-02-21, 1392/12/02
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison efficacy of retinoids acid 5% with microdermabrasion and microdermabrasion with placebo in treatment of photoaging
Public title
Efficacy of retinoic acid5% cream with microdermabrasion in treatment of photoaging
Purpose
Treatment
Inclusion/Exclusion criteria
A- Inclusion criteria: patient informed consent for participation, no sensitivity to retinoic acid compounds, no treating for photoaging for at list three months before participation in study.B- exclusion criteria: no using drug regularly or no referring regularly for microderm abrasion, patient discontinuing intervention, using other treatment modality within study
Age
From 35 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Blinding is doing for patient's group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan university of medical sciences
Street address
Isfahan university of medical sciences, Hezar Jerib street,Isfahan.
City
Isfahan
Postal code
00
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
394084

Health conditions studied

1

Description of health condition studied
Photoaging
ICD-10 code
L90-9
ICD-10 code description
Atrophic disorder of skin, unspecified

Primary outcomes

1

Description
Photoaging lesions
Timepoint
Baseline, two weeks, one month، two month and four months after start of treatment
Method of measurement
Gloagu grading system

Secondary outcomes

1

Description
Side effect of treatment with microdermabrasion and retinoic acid 5% peeling
Timepoint
Two week, one month, two month and four month after start of treatment
Method of measurement
Visional clinical evaluation

Intervention groups

1

Description
Right side of the face is treated with microderm abrasion and retinoic acid 5% peeling. At first, the face is cleaned by aceton, then is treated with microdermabrasion with 70 mmHg. This device is work by use of aluminum oxide crystals and abraded stratum corneum and superficial epiderm. Device that used in this study is referred to Zagromed Company. After this stage, retinoic acid5% cream that was made by pharmacist is used on the right side of face. Then recommended to patient to wash it after 4 hours. Until three days the patient must be used hydrocortisone 1% cream twice daily and must be used sunscreen and emollient regularly. Treatment will be done in three sessions with one month interval.
Category
Treatment - Devices

2

Description
Left side of the face is treated with microdermabrasion and placebo. At first, the face is cleaned by aceton, then is treated with microdermabrasion with 70 mmHg. This device is work by use of aluminum oxide crystals and abraded stratum corneum and superficial epiderm. Device that used in this study is referred to Zagromed Company. After this stage, placebo that was made by the base of usage cream for peeling, is used on the left side. Then recommended to patient to wash it after 4 hours. Until three days the patient must be used hydrocortisone 1% cream twice daily and must be used sunscreen and emollient regularly. Treatment will be done in three sessions with one month interval.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr Saghi fatemi tabaei
Street address
Alzahra hospital, Sofe street, Isfahan
City
Isfahan

2

Recruitment center
Name of recruitment center
Sedighe tahere research center
Full name of responsible person
Dr Saghi fatemi tabaei
Street address
Khorram street, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of Isfahan university of medical sciences
Full name of responsible person
Dr mansoor siavash, Vice chancellor of Isfahan university of medical sciences
Street address
Isfahan university of medical sciences, Hezar Jerib street
City
Isfahan
Grant name
12345
Grant code / Reference number
12345
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Isfahan university of medical sciences
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
Isfahan university of medical sciences
Full name of responsible person
Dr Saghi fatemi tabaei
Position
Dermatology resident
Other areas of specialty/work
Street address
Dermatology group, Alzahra hospital, Sofe street, Isfahan
City
Isfahan
Postal code
8174675731
Phone
+98 31366855555
Fax
+98 31 3624 4221
Email
Mehrabi@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Dr Gita faghihi
Position
Dermatology professor
Other areas of specialty/work
Street address
Dermatology group, Alzahra hospital
City
Isfahan
Postal code
8174675731
Phone
+98 31366855555
Fax
+98 31 3669 2174
Email
g_faghihi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Dr Saghi fatemi tabaei
Position
Dermatology resident
Other areas of specialty/work
Street address
Dermatology group, Alzahra hospital, Sofe street, Isfahan
City
Isfahan
Postal code
8174675731
Phone
+98 31366855555
Fax
+98 31 3624 4221
Email
mehrabi@mui.ac.ir
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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