Evaluation of Topical curcumin versus topical zinc oxide in treatment of diaper rash
Design
A controlled clinical trial with parallel, double-blind, randomized, phase 3 groups on 44 patients. The randomization tool of the graphpad.com/quickcalcs/randMenu website was used for randomization
Settings and conduct
This project will take place at Shahid Sadoughi hospital in Yazd. Patients in two groups of 22 people use curcumin or zinc oxide cream twice a day for 5 days
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged less than 2 years; diagnosed with diaper dermatitis. Exclusion criteria: Secondary infectious dermatitis; Use of any corticosteroid; A history of atopic dermatitis, candidiasis, or seborrheic dermatitis;
Birth defect
Intervention groups
In order to evaluate the effectiveness of topical curcumin in diaper rash, we give a group of 22 people with curcumin and a group of 22 people with a zinc oxide.
Main outcome variables
Erythema intensity,
Erythema extent
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N18
Registration date:2023-10-29, 1402/08/07
Registration timing:retrospective
Last update:2023-10-29, 1402/08/07
Update count:0
Registration date
2023-10-29, 1402/08/07
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Topical curcumin versus topical zinc oxide in treatment of diaper rash
Public title
Topical curcumin compared topical zinc oxide in treatment of diaper rash
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged less than 2 years
Diagnosed with diaper dermatitis
Exclusion criteria:
Secondary infectious dermatitis
Use of any corticosteroid
A history of atopic dermatitis, candidiasis, or seborrheic dermatitis
Birth defect
Age
To 2 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Forty-four of screened patients met the inclusion criteria. These were randomly allocated to the intervention group (n=22) and control group (n=22) using an online randomization tool: graphpad.com/quickcalcs/randMenu.Then the same numbered curcumin or Zinc Oxide containers were given to the caregivers for use in the intervention and control groups. One of the researchers (Behrooz Heydari) was responsible for this assignment and was the only member aware of randomization and allocation. He did not participate in the evaluation of outcomes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, 44 patients were randomly divided into two treatment groups (A and B). In order to randomize, the block random allocation method was used, in which 10 blocks of 5 were considered. The letters A and B. These permutations were generated with the help of Random software distribution software version 1. For this purpose, the list prepared by software No. 1 to 44 is in 10 blocks of five in general to implement this I want the software output to the first eligible person number 1 and I want to select the last person number 44.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-05-18, 1398/02/28
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.082
Health conditions studied
1
Description of health condition studied
Diaper rash
ICD-10 code
L22
ICD-10 code description
Diaper dermatitis
Primary outcomes
1
Description
Evaluation of erythema severity
Timepoint
Days one, three and five after the intervention
Method of measurement
Based on scoring the severity of diaper dermatitis scale
Secondary outcomes
1
Description
Patients' recovery compared to the first day of intervention
Timepoint
The first, third and fifth day after intervention
Method of measurement
Observation and comparison of erythema severity, extent of dermatitis and clinical manifestations
Intervention groups
1
Description
Intervention group: After 2% curcumin cream formulation, use topically after each diaper change for 5 days
Category
Treatment - Drugs
2
Description
Control group: Topical zinc oxide ointment 20% (Caspian Company), applied topically after each diaper change for 5 days