Evaluation of clinical and dermoscopic effects of topical use of KOH 5% solution on Actinic Keratosis and its comparison with 5-Fluorouracil topical cream on patients suffering Actinic Keratosis.
Specifying the therapeutic effects of KOH 5% in comparison to 5-Fluorouracil cream on Actinic Keratosis (main aim).
Specifying the relationship between the therapeutic effects of KOH 5% and 5-Fluorouracil cream with patient's age, radiotherapy histor, and patient's skin color classification based on Fitzpatrick scale (secondary aims).
Design
KOH 5% is used on half of the lesions and 5-Fluorouracil cream is used on the other half. Sides on which, each drug is used for each patient, is randomized using four-way Block Randomization method. Lesions are divided into 2 groups of left side lesions (L) and right side lesions (R). The fact that each number (patient) uses which drug on which side, is randomized. The sample size is 25 people.
Settings and conduct
Patients suffering Actinic Keratosis attending Razi dermatology hospital will be using both medicines simultaneously for 4 weeks. All patients will be examined before the intervention begins, 14, 28, 60 and 90 days after starting treatments. The clinical traits of the lesions and their improvement process will be examined and photographed using "FotoFinder" dermoscope and will then be analyzed by two of the dermatology professors who will have a blind observation on the taken pictures.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Actinic Keratosis patients who are at least 18 years old, and have a minimum number of 8 lesions (at least 4 per side) on parts of skin exposed to the sun.
Exclusion criteria: All pregnant women and people with a history of allergy to any of the drugs under study.
Intervention groups
Checking the therapeutic effects of KOH 5% on half of a person's lesions of Actinic Keratosis (As intervention group) in comparison to the effects and side effects of 5-Fluorouracil cream on the other half of lesions (As control group).
Main outcome variables
Smoothing of Actinic Keratosis's roughness of lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180909040978N1
Registration date:2018-10-19, 1397/07/27
Registration timing:prospective
Last update:2018-10-19, 1397/07/27
Update count:0
Registration date
2018-10-19, 1397/07/27
Registrant information
Name
Ali Salehi Farid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 2312
Email address
asalehifarid@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2018-11-01, 1397/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical and dermoscopic effects of topical use of KOH 5% solution on Actinic Keratosis and its comparison with 5-Fluorouracil topical cream on patients suffering Actinic Keratosis.
Public title
Evaluation of treatment of actinic keratosis with KOH5% solution in comparison to Fluorouracil 5% cream
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suffering Actinic Keratosis attending Razi dermotology hospital
Having at least 18 years of age
Having a minimum number of 8 lesions( 4 on each side, at least) on parts of skin that are exposed to the sun.
Exclusion criteria:
Pregnant women
People with a history of allergy to any of the drugs under study.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
8
Having a minimum number of 8 lesions( 4 on each side, at least) on parts of skin that are exposed to the sun.
Randomization (investigator's opinion)
Randomized
Randomization description
Sides on which, each drug is used for each patient, is randomized using four-way Block Randomization method. Patients are numbered 1 to 25. Lesions are divided into two groups of left side lesions (marked with letter L) and right side lesions (marked with letter R). The fact that each number (patient) uses which drug on which side ( left side lesions (L) or right side lesions (R) ), is randomized using Block Randomization method. In fact, each patient's lesions are considered the statistical society, so randomization has taken place within each individual.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
13th ّFlr., Block A, Central HًQs of the Ministry of Health & Medical Education, Simaye_Iran St., Qods Town
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.TUMS.TIPS.REC.1397.010
Health conditions studied
1
Description of health condition studied
Actinic Keratosis
ICD-10 code
L57.0
ICD-10 code description
Actinic keratosis
Primary outcomes
1
Description
Smoothing of Actinic Keratosis's lesions' roughness
Timepoint
At the beginning of the study (Before the intervention begins) and 14, 28, 60 and 90 days after starting the use of KOH 5% solution and Fluorouracil cream
Method of measurement
Clinical diagnosis by dermatologist
Secondary outcomes
1
Description
The improvement of dermoscopic features of Pseudo-network pattern's lesions.
Timepoint
At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream
Method of measurement
Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.
2
Description
The improvement of dermoscopic feature of Yellow scales' lesions.
Timepoint
At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream
Method of measurement
Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.
3
Description
The improvement of dermoscopic feature of White scales' lesions.
Timepoint
At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream
Method of measurement
Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.
4
Description
The improvement of dermoscopic feature of Linear-Wavy Vessels' lesions.
Timepoint
At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream
Method of measurement
Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.
5
Description
The improvement of dermoscopic feature of Pigmented Dots' lesions
Timepoint
At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream
Method of measurement
Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.
Intervention groups
1
Description
Intervention group: Patients suffering Actinic Keratosis attending Razi dermatology hospital who are at least 18 years old and have a minimum number of 8 lesions (4 on each side, at least) on parts of skin that are exposed to the sun, will be recognized. A group of 25 people is chosen from among these patients. The chosen patients are explained about the medicine, the manner of using the medicine, probable side effects, mandatory use of sun screen and the importance of signing the letter of satisfaction. KOH 5% (Produced and packed in Razi hospital's laboratory of compounding drugs) and Fluorouracil 5% cream (This medicine is available in pharmacies under commercial name of Efudix in 20-gram tubes) are handed to the patients. Patients will be using the two medicines simultaneously for 4 weeks. Patients are taught to use KOH 5% for one half of the lesions and Fluorouracil 5% cream for the other half.
Category
Treatment - Drugs
2
Description
Control group: Patients suffering Actinic Keratosis attending Razi dermatology hospital who are at least 18 years old and have a minimum number of 8 lesions (4 on each side, at least) on parts of skin that are exposed to the sun, will be recognized. A group of 25 people is chosen from among these patients. The chosen patients are explained about the medicine, the manner of using the medicine, probable side effects, mandatory use of sun screen and the importance of signing the letter of satisfaction. KOH 5% (Produced and packed in Razi hospital's laboratory of compounding drugs) and Fluorouracil 5% cream (This medicine is available in pharmacies under commercial name of Efudix in 20-gram tubes) are handed to the patients. Patients will be using the two medicines simultaneously for 4 weeks. Patients are taught to use KOH 5% for one half of the lesions and Fluorouracil 5% cream for the other half.
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 data are shareable, except for patients' pictures, after anonymizing the patients.
When the data will become available and for how long
All data are shareable 6 months after publishing the results, except for the patients' pictures, after anonymizing the patients.
To whom data/document is available
Researchers working in universities or science institutions or people working in industrial areas, can receive the data or other documents on the study.
Under which criteria data/document could be used
The data or the other documents on the research, except for patients' pictures, can be used for systematic review or any other purpose provided having legal permission from the owners of the study.
From where data/document is obtainable
1:
Dr. Hamidreza Mahmoudi
E-mail address: hr_mahmoody@yahoo.com
Mobile-phone number: 00989122612946
Razi hospital
2:
Dr. Ali Salehi Farid
E-mail address: ali.salehi.farid@gmail.com
Mobile-phone number: 00989123711774
What processes are involved for a request to access data/document
Using the data or documents is possible after one month, provided having the legal permission of the owners of the study, by one of the authorized people.