Finding a safer topical formulation of existing treatments to speed up the healing of foot dermatitis lesions in children aged 2 to 6 years
Design
Single blind Open label Quasi experimental
Settings and conduct
Dermatology clinics affiliated to Isfahan University of Medical Sciences
Participants/Inclusion and exclusion criteria
All children suffering from juvenile plantar dermatitis (Juvenile Plantar Dermatitis) with mild to moderate involvement who referred to dermatology clinics affiliated to Isfahan University of Medical Sciences between the fall of 1402 and the end of winter 1402 and have the entry criteria as follows:
2 to 6-year-old child with a clinical diagnosis of Juvenile Plantar Dermatitis
Lack of evidence and history Contact dermatitisChemical
Absence of causes of fungal dermatophytic diseases of the skin
Not taking other medications to relieve cracking, scaling, pain and burning in the soles of the feet during the last two weeks
Consent and informed consent of children's parents to enter this research project
Intervention groups
The role of the intervention is independent and nominal.
The description of the intervention or drug prescription is that after getting the cooperation of the child, it will be explained to the parents that twice a day and each time at the rate of 1-2 finger tips of the medicine (depending on the extent of the lesion) apply to the soles of the child.
Main outcome variables
child's age
gender of the child
height
Weight
Duration of dermatitis
Type of drug intervention / drug-free cream
Underlying disease
Received medications
Foot dermatitis scale score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090808002306N9
Registration date:2024-03-15, 1402/12/25
Registration timing:registered_while_recruiting
Last update:2024-03-15, 1402/12/25
Update count:0
Registration date
2024-03-15, 1402/12/25
Registrant information
Name
Ali Mohammad Sabzghabaee
Name of organization / entity
Isfahan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7070
Email address
sabzghaba@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-10, 1402/12/20
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical efficacy of a dermal formulation of Dimethicone in the treatment of plantar dermatitis in children aged two to six years
Public title
The clinical efficacy of a dermal formulation of Dimethicone in the treatment of plantar dermatitis in children aged two to six years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children suffering from juvenile plantar dermatitis (Juvenile Plantar Dermatitis) with mild to moderate involvement who referred to dermatology clinics affiliated to Isfahan University of Medical Sciences between the fall of 1402 and the end of winter 1402 and met the entry criteria as described below. be: 2 to 6-year-old child with a clinical diagnosis of Juvenile Plantar Dermatitis (cracks, roughness, flaking, pain and burning in the soles of the feet)
Lack of evidence and history Contact dermatitisChemical
Absence of causes of fungal dermatophytic diseases of the skin
Not taking other medications to relieve cracking, scaling, pain and burning sensation in the soles of the feet during the last two weeks
Consent and informed consent of children's parents to enter this research project
Exclusion criteria:
Age
From 2 years old to 6 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Individual simple randomization
Randomization tool: using software (2017 NCSS-PASS (Jeri Hintze, USA
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participant is blinded
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
2
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Pharmacy
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-11-18, 1402/08/27
Ethics committee reference number
IR.MUI.PHANUT.REC.1402.038
Health conditions studied
1
Description of health condition studied
Juvenile Plantar Dermatitis, JPD
ICD-10 code
L12.2
ICD-10 code description
Chronic bullous disease of childhood
Primary outcomes
1
Description
Child's age, child's sex, height, weight, duration of dermatitis, type of drug intervention / drug-free cream, underlying disease, medications received, foot dermatitis scale score
Timepoint
The soles of the right feet of the eligible people, who were sampled based on the entry criteria using the easy method, as the case (treatment with topical cream of 5% dimethicone twice a day) and the sole of their left foot as the control (treatment with the topical base cream without dimethicone twice a day as standard treatment and current basis) are placed. In this study, by dividing the legs of qualified people into right and left, each child is practically his own witness. Both legs of the study subjects, before the study and one week after using the drug, were evaluated by a dermatologist in terms of severity and severity of the disease, erythema, vesiculation, scaling, and skin cracks, and the information was provided by the student. The final year of pharmacy will be recorded, categorized and analyzed.
Method of measurement
The soles of the right feet of the eligible people, who were sampled based on the entry criteria using the easy method, as the case (treatment with topical cream of 5% dimethicone twice a day) and the sole of their left foot as the control (treatment with the topical base cream without dimethicone twice a day as standard treatment and current basis) are placed. In this study, by dividing the legs of qualified people into right and left, each child is practically his own witness. Both legs of the study subjects, before the study and one week after using the drug, were evaluated by a dermatologist in terms of severity and severity of the disease, erythema, vesiculation, scaling, and skin cracks, and the information was provided by the student. The final year of pharmacy will be recorded, categorized and analyzed. For the clinical assessment of the intensity of each symptom and scoring them, the standard rating of dermatitis will be used (4). This grading is as follows: 0: No symptoms, 1: Mild, 2: Moderate, 3: Moderately severe, 4: Severe. Also, the researcher will evaluate the response to the treatment according to the following scale and grading. 0: Completely clean and clear with the possibility of hyperpigmentation. Residual 1: Almost clean with very clear (about 90%) 2: Marked and significant improvement (about 75%) 3: Moderate improvement, between marked and partial marks that indicate about 50% improvement. 4: Partial improvement ( about 25%) and the significant presence of disease 5: No change and improvement (moderate to severe disease) 6: The worst evaluation of the subject under study included completing a 100 mm visual analog scale for itching.(0 mm: no itching, 100 mm: the worst imaginable itching) Also, the safety of the drug was evaluated by recording the incidence of side effects in all patients. The total scores for erythema, vesiculation, scaling, firmness and skin fissures, to create a The combined severity index and mixed score will form the final patients.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Children in the control group could be themselves, with one leg receiving the main treatment (dimethicone-containing cream) and one leg receiving only the base cream.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinics of Imam Hossein Children's Hospital
Full name of responsible person
-
Street address
Isfahan-Imam Khomeini Street-before the University of Technology block-Skin Clinic of Imam Hossein Children's Specialized Hospital (AS)
City
Isfahan
Province
Isfehan
Postal code
8195163382
Phone
+98 31 3386 1012
Email
Imamhossein@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
-
Street address
Hazarjarib St. - Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8173673461
Phone
+98 31 3668 8064
Email
pharm.mui@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Sabzghabaee
Position
Professor of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Doctorate in clinical pharmacy
Street address
Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Pharmacy
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
031337927070
Email
Sabghaba@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Ali Mohammad Sabzghabaee
Position
Professor of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Doctorate in clinical pharmacy
Street address
Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Pharmacy
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
031337927070
Email
sabzghaba@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Sabzghabaee
Position
Professor of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Doctorate in clinical pharmacy
Street address
Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Pharmacy
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
031337927070
Email
Sabzghaba@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, considering that the questionnaire is answered by the child's parents, it is possible to share the questionnaires and the results of the statistical analysis of the data if necessary.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers who are engaged in the study
Under which criteria data/document could be used
In case of any inconsistency between the results or creating doubt and lack of transparency in the results and any part of the study steps
From where data/document is obtainable
Dr. Ali Mohammad Sabzegbaee
Dr. Bahareh Abtahi
Dr. Erfaneh Ghassami
Kimia Majidi Iraj
What processes are involved for a request to access data/document
The applicant must first present his request to the researchers of this study and then this request will be transferred by the researchers to the ethics committee and be examined.