Comparison of efficacy and safety of Glycolic acid ۷۰% peel with topical Tretinoin ۰.۰۵% in the treatment of Acanthosis Nigricans patients.
Design
30 Acanthosis Nigricans patients with involvement of axilla or neck enter this study. During baseline appointment, demographic features and BMI for each patient is documented and baseline photographs are obtained. Randomly each patient is treated with Glycolic acid 70% chemical peel every 2 weeks for 4 sessions for lesions on one side of the body and with topical Tretinoin 0.05% every other night on the opposite side. On week 8 new photographs are obtained and compared with baseline photographs, then the patient, the project manager and 2 other dermatologists rank the response rate to each treatment.
Settings and conduct
Chemical peeling with Glycolic acid 70% will be performed by the project manager on the lesions of one side every 2 weeks at Razi hospital. Tretinoin cream will be provided by the project manager for the patients during the baseline appointment and instructions will be provided. The patients and the project manager rank the response rate and side effect of treatments unblinded at 8th week, but 2 other dermatologist will be blinded.
Participants/Inclusion and exclusion criteria
Acanthosis Nigricans patients with
1) Axilla or neck involvement
2)12 years of age or older
3)Signing the Informed consent
4)no previous treatment of the lesions in the past month
5)willingness for participation in the study
Items leading to exception from the study
1) Contraindication for topical Tretinoin and/or Glycolic acid
2) Pregnancy and lactation
3) underlying malignancy
Intervention groups
Each patient is treated with Glycolic acid 70% chemical peel every 2 weeks for 4 sessions on one side of the lesions and with topical Tretinoin 0.05% every other night on the opposite side.
Main outcome variables
Clinical improvement of the lesions/ Side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221129056666N1
Registration date:2023-01-24, 1401/11/04
Registration timing:retrospective
Last update:2023-01-24, 1401/11/04
Update count:0
Registration date
2023-01-24, 1401/11/04
Registrant information
Name
Rana Samii
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2280 7479
Email address
raanasamiei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of efficacy and safety of Glycolic acid 70% peel with topical Tretinoin 0.05% in the treatment of Acanthosis Nigricans patients
Public title
Acanthosis Nigricans project
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Acanthosis Nigricans lesions of axilla or neck.
Patients with the informed consent for participating in the study.
Exclusion criteria:
Pregnancy or Lactation
Patients with underlying malignancy.
Patients with contraindicatons for topical Tretinoin or Glycolic acid.
History of treatment of the lesions in the past month.
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient is treated with topical Tretinoin on one side of neck or axilla, and with Glycolic acid on the other side.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was used in this study. In this method simple randomization models like tossing a coin , using randomized number tables or computerized methods of randomization is used. In this method each case is allocated in one group ( Tretinoin or Glycolic acid) by tossing a coin for example.
Some advantages of this method are unpredictability of treatment used for each side. Implementing of this method is simple. Randomization unit of this study is each case. Randomization software was used for randomization. This software gave us the ability to choose a desired method of randomization among several others. Randomization sequence was created using randomizer software. The sequence was created asking the software to divide 60 cases in to two groups of 30 (0 or 1) equally. Central allocation concealment was used in this study. In this method randomization sequence is available for the manager of the study to apply to the patients accordingly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Since Acanthosis Nigricans lesions develope symmetrically in patients, each patient is treated with topical Tretinoin on one side and with Glycolic acid on the other side, in order to compare the efficacy of these two treatments in each patient with the identical parameters. Since each side of the patient is treated with a different form of treatment, it is impossible to blind the pateints. The specialists that evaluate the outcome of these treatments are however blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences school of Medicine
Street address
Room no. 604 , 6th floor, Tehran University of Medical Sciences main campus, Qods St. , Keshavarz Blvd. , Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-12-19, 1400/09/28
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1062
Health conditions studied
1
Description of health condition studied
Acanthosis Nigricans
ICD-10 code
L83
ICD-10 code description
Acanthosis nigricans
Primary outcomes
1
Description
Degree of resolution of Acanthosis Nigricans lesions
Timepoint
8 weeks after initiation of therapy and 4 treatment sessions
Method of measurement
Comparison with pre treatment photographs
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acanthosis Nigricans lesions of one side of the axilla/ groin is treated with Glycolic acid 70% for 4 sessions every 2 weeks. The result of treatment is compared with initial photographies 2 weeks after the last session.
Category
Treatment - Drugs
2
Description
Intervention group: The opposite side of axilla/ groin will be treated with topical Tretinoin cream 0.05% every other night. The result of this treatment is compared with initial photographies after 8 weeks of treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Rana Samii
Street address
Vahdat Eslami Sq.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Email
razihospital@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of medical sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Rana Samii
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami Sq.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0174
Email
Raanasamiei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rana Samii
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami Sq.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0174
Email
Raanasamiei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rana Samii
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami Sq.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0174
Email
Raanasamiei@gmail.com
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
Yes - There is 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
All non recognizable patients information, study design, analytic studies, and the informed consent will be available for publication.
When the data will become available and for how long
6 months after submission
To whom data/document is available
All the scientist, professors who are studying in the field of dermatology, endocrinology, and pharmacology.
Under which criteria data/document could be used
For future studies.
From where data/document is obtainable
Via emial to the submitted email address.
What processes are involved for a request to access data/document
After submission of their request along with their CV and the propose of their request to may email.