A randomized, clinical trial with a parallel group design
Settings and conduct
Patients with keloid who referred to the dermatology clinic of Shohada and Loghman Hospitals in 1398و were divided into two groups of intervention and control based on a random table
Participants/Inclusion and exclusion criteria
Inclusion criteria include skin type 2 to 5 based on Fitzpatrick,having 1 to 3 keloids 1 to 5 cm in diameter from neck to bottom.also,Exclusion criteria include hypersensitivity to bleomycin, pregnancy, and lactation
Intervention groups
The intervention group will receive intralesional Bleomycin with cryotherapy and the control group will receive intralesional Triamcinolone with cryotherapy
Main outcome variables
Pigmentation; vascularity; flexibility; thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200108046060N1
Registration date:2020-01-18, 1398/10/28
Registration timing:registered_while_recruiting
Last update:2020-01-18, 1398/10/28
Update count:0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Ali Forghanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
ali_forghanian8611@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of intralesional Bleomycin plus cryotherapy versus intralesional Triamcinolone plus cryotherapy in the treatment of keloid
Public title
Effect of Bleomycin plus cryotherapy in treatment of keloid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Skin type 2 to 5 based on Fitzpatrick
Having 1 to 3 keloids 1 to 5 cm in diameter from neck to bottom
Exclusion criteria:
Unwillingness to participate in the study
Hypersensitivity to Bleomycin
Pregnancy
Lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by simple randomization method based on random number table.
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 Shahid Beheshti University of Medical Science