Comparison of the effect of TCA (20%) trichloroacetic acid and topical combination of steroid and tretinoin in macular amyloidosis; a double blind clinical trial.
A Comparison of the Effect of 20% Trichloroacetic Acid (TCA) and the Combination of Topical Steroid and Tretinoin in the Treatment of Macular Amyloidosis
Design
This study is a parallel group, double-blind randomized clinical trial study. The phase of the study is 3. The sample number is 20.
Settings and conduct
This study is done at Dermatology Clinic of Sabzevar Vasei Hospital.
Given that macular amyloidosis is a sympathetic disease, TCA 20% will be used for one side and the topical combination of steroid and tretionin will be used for the other side of the body. A month later, patients will be referred to a doctor who is not aware of the intervention and the pigmentation changes will be evaluated and recorded. This will be done for three one-month courses.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with macular amyloidosis referred to dermatology clinic of Vasei Hospital in Sabzevar; being at the age of 25 to 45 years; satisfaction to participate the study.
Intervention groups
Given that macular amyloidosis is a sympathetic disease, TCA 20% will be used for one side and the topical combination of steroid and tretionin will be used for the other side of the body.
Main outcome variables
cutaneous pigmentation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180102038188N1
Registration date:2018-06-13, 1397/03/23
Registration timing:registered_while_recruiting
Last update:2018-06-13, 1397/03/23
Update count:0
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Edriss Arezoumand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5423 0263
Email address
arezomande90@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of TCA (20%) trichloroacetic acid and topical combination of steroid and tretinoin in macular amyloidosis; a double blind clinical trial.
Public title
The effect of TCA (20%) trichloroacetic acid and topical combination of steroid and tretinoin in macular amyloidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with macular amyloidosis referring to dermatology clinic of Sabzevar Vasei Hospital
Being at the age of 25 to 45 years
Satisfaction to participate in the study
Exclusion criteria:
Age
From 25 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Given that macular amyloidosis is a sympathetic disease, TCA 20% will be used for one side and the topical combination of steroid and tretionin will be used for the other side of the body.
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method based on gender and using PASS software will be used in this study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, patients and outcome evaluators who is dermatologist will be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Approval date
2018-03-05, 1396/12/14
Ethics committee reference number
IR.MEDSAB.REC.1396.160
Health conditions studied
1
Description of health condition studied
Macular amyloidosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cutaneous pigmentation
Timepoint
0, 1, 2 and 3 months later
Method of measurement
Checklist completed by dermatologist
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: Given that the disease is a sympathetic disease, on one side of the body, TCA 20% will be used. This intervention will be done for three one month periods.
Category
Treatment - Drugs
2
Description
Control group: In this group, routine treatment including topical composition containing triamcinolone 15 grams and tretinoin 15 grams) will be performed for the other side of the back. This intervention will be done for three one month periods.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Maryam Karabi
Street address
Vasei Hospital; Tawhid City Road
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 21 4401 8317
Email
arezomande90@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Ghorat
Street address
Vasei Hospital, Towhid Shahr Road
City
sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 21 4401 8317
Email
arezomande90@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Maryam Karabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vasei Hospital, Towhid Shahr Road
City
sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 21 4401 8317
Email
arezomande90@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Maryam Karabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vasei Hospital, Towhid Shahr Road
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 21 4401 8317
Email
arezomande90@medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Maryam Karabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vasei Hospital, Towhid Shahr Road
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 21 4401 8317
Email
arezomande90@medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, only a portion of the data will be shared, such as the primary and secondary outcomes.
When the data will become available and for how long
Get started since 1398
To whom data/document is available
This study will be available to all people in the community.
Under which criteria data/document could be used
-
From where data/document is obtainable
Dr Maryam Karabi, Sabzevar University of Medical Sciences.
What processes are involved for a request to access data/document
Contact with Research and Technology Unit of Sabzevar University of Medical Sciences