Evaluation of therapeutic effects on dermoscopic manifestations & complications of hydrogen peroxide on actinic keratosis and its comparison with cryotherapy in patients admitted to Razi Hospital in 2018; We also examined the effect of age and history of radiotherapy and skin color on this study
Design
A randomized clinical trial with control group
Settings and conduct
group of 25 patients is selected. Each patient's side of the drug application is selected by Block Randomization. Treatment of these patients is performed by the physician in the first session and is repeated on days 22 & if there is
Failure to heal one more session after 3 weeks. Clinical examinations, photography and dermoscopy are performed at each visit. Finally, two dermatologists were blindly reviewing the photos
Participants/Inclusion and exclusion criteria
A group of 25 patients from patients who are referred to the dermatology clinics of Razi Hospital who had at least 4 actinic keratosis on sun exposed areas and who had not received any other treatment for these lesions are going to be selected.
Intervention groups
In each treatment session, the lesion is completely cleansed with isopropyl alcohol and then the drug used on one side of the scalp with a single-use applicator rotated firmly for approximately 20 seconds on the lesions & again after 60 minutes the procedure will be repeated for three other rounds.
To perform cryotherapy on the lesion control side, liquid nitrogen on one side of the scalp with a disposable applicator rotating at a pressure of approximately 15 seconds & again after 60 minutes the procedure will be repeated for one other round. to the extent that a 1–2 mm margin is created around the scrape.
Main outcome variables
Replacement of hydrogen peroxide solution with cryotherapy in the treatment of AK with similar or greater efficacy and fewer complications and greater ease of use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190928044912N1
Registration date:2021-04-23, 1400/02/03
Registration timing:retrospective
Last update:2021-04-23, 1400/02/03
Update count:0
Registration date
2021-04-23, 1400/02/03
Registrant information
Name
Delara Amir Dastmalchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2241 8337
Email address
delara.adastmalchi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of treatment of actinic keratosis with 35% hydrogen peroxide in comparison to cryotherapy
Public title
Evaluation of treatment of actinic keratosis with hydrogen peroxide
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are at least 18 years old with at least 4 actinic keratosis on the skin areas that are sun exposed
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient's side drugs application is selected by using Block Randomization & Finally, two dermatologists will blindly examine the dermographic and dermoscopic photographs and determine the extent of lesion healing based on the dermoscopic manifestations.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, two dermatologists will blindly examine dermographic and dermoscopic photographs and compare the therapeutic effects and side effects of these two methods, as well as Each patient's side for drug's application is selected by using Block Randomization
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