Evaluation of safety and clinical efficacy of Firooz brand name fissure cream containing lanolin in improving the pain and severity of fissure lesions in lactating women
Evaluation of safety and clinical efficacy of Firooz brand name fissure cream containing lanolin in improving the pain and severity of fissure lesions in lactating women
Design
Single group, before -after, phase 2 clinical study. sample size is 20. The study is not randomized.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy in Tehran, 20 lactating women suffering from fissure of nipple will be selected and enrolled in the study after signing consent form. Volunteers will be taught to use Firooz brand lanolin cream on the nipple and areola at least 5 times a day after each breastfeeding. Before intervention and 48 hours and 7 days after that satisfaction of participants will be measured. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Lactating women aged 18 to 45 with term babies (weighing 2500 to 4000 grams)
Chest pain from severity 1 to 3, General health, Signing the consent form for participation in the study
Exclusion criteria: People with puerperal fever, A newborn suffering from jaw and mouth abnormalities such as short frenulum or oral infections, Mothers suffering from diabetes, Use of any local treatment for fissure three days before the study
Intervention groups
Using Firooz brand lanolin cream on the nipple and areola at least 5 times a day after each breastfeeding.
Main outcome variables
Pain during breastfeeding; Severity of fissure of nipple
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N27
Registration date:2022-10-29, 1401/08/07
Registration timing:prospective
Last update:2022-10-29, 1401/08/07
Update count:0
Registration date
2022-10-29, 1401/08/07
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and clinical efficacy of Firooz brand name fissure cream containing lanolin in improving the pain and severity of fissure lesions in lactating women
Public title
Evaluation of Firooz fissure cream containing lanolin in improving the pain and severity of fissure lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lactating women aged 18 to 45 with term babies (weighing 2500 to 4000 grams)
General health
Signing the consent form for participation in the study
Breast pain from severity 1 to 3
Exclusion criteria:
People with puerperal fever
A newborn suffering from jaw and mouth abnormalities such as short frenulum or oral infections
Mothers suffering from diabetes
Use of any local treatment for fissure three days before the study
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of medical school-Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.533
Health conditions studied
1
Description of health condition studied
Fissure of nipple
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
Pain during breastfeeding
Timepoint
Before intervention, 48 hours and 7 days after that
Method of measurement
By a 6-point Likert scale (Not satisfied at all = 0, Very little = 1, Little = 2, Average = 3, Much = 4 and Very much = 5)
Secondary outcomes
1
Description
Severity of fissure of nipple
Timepoint
Before intervention, 48 hours and 7 days after that
Method of measurement
Severity of fissure of nipple 1 to 3 based on: 0) No microscopically visible skin changes, 1) Erythema or edema or combination of both, 2) Superficial damage with or without scab formation on <25% of the nipple surface, 3) Superficial damage with or without scab formation on >25% of the nipple surface, 4) Partial-thickness wound with or without scab formation on <25% of the nipple surface, 5) Partial-thickness wound with or without scab formation on <25% of the nipple surface
Intervention groups
1
Description
Intervention group: Using Firooz brand lanolin cream on the nipple and areola at least 5 times a day after each breastfeeding.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy