Comparison of the Effectiveness of Topical NAC and Zinc Oxide in the Treatment of Diaper Dermatitis
Design
A double-blind randomized controlled clinical trial phase 3 with a parallel-group design of 44 patients. Randomized by using an online tool :graphpad.com/quickcalcs/randMenu
Settings and conduct
This study was performed in the pediatric ward of Shahid Sadoughi Hospital in Yazd on patients less than 2 years old with diaper dermatitis. Patients who met the inclusion criteria were randomly divided into two groups: 3% NAC and 20% zinc oxide. Topical product was used after each diaper change. Mothers were taught non-pharmacological measures such as washing after each diaper change so that the two groups were not different in terms of non-pharmacological measures. Patients' information including age, sex, weight, underlying diseases, and medications were extracted from the file. In addition to the initial assessment (day 1), the severity of the lesions was assessed on days 3 and 5. The patients of the two groups were compared in terms of the duration of the disease and the degree of reduction in the severity of dermatitis. This study is a double-blind clinical trial in which the patient and analysts had no information about the individuals in the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion: Patients aged less than 2 years who had been diagnosed with diaper dermatitis.
Exclusion: Secondary infectious dermatitis; use of any kind of corticosteroid; a history of atopic dermatitis, candidiasis, or seborrheic dermatitis; birth defect.
The severity of erythema and irritation, the extent of diaper dermatitis, presence or absence of papules and pustules, examination of uncoated surface skin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N6
Registration date:2022-01-09, 1400/10/19
Registration timing:retrospective
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
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
2019-06-22, 1398/04/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2019-07-11, 1398/04/20
Actual recruitment end date
2019-11-03, 1398/08/12
Trial completion date
2019-11-03, 1398/08/12
Scientific title
Comparison of the Effectiveness of Topical N-Acetylcysteine and Zinc Oxide in the Treatment of Diaper Dermatitis
Public title
Topical N-Acetylcysteine and Zinc Oxide in the Treatment of Diaper Dermatitis
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
Actual sample size reached:
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 N-acetylcysteine 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 participants, the caregivers, and one of the researchers ( Nazgol Kermanshahi) collecting and assessing data were unaware of the assigned intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi university of medical science
Street address
Shahid Sadoughi university of medical science, Shohadai Gomnam Blvd, Professor Hesabi Blvd
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.083
Health conditions studied
1
Description of health condition studied
Diaper Dermatitis
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 3% N-acetylcysteine 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