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CTRI Number  CTRI/2024/05/067254 [Registered on: 13/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To estimate the water loss through the epidermis and a scale called Eczema area and severity index to compare the efficacy of two topical medications called crisaborole 2% and tacrolimus 0.1% in patients with mild to moderate atopic dermatitis. 
Scientific Title of Study   Estimation of transepidermal water loss and eczema area and severity index in patients with mild to moderate atopic dermatitis receiving topical crisaborole 2 % vs topical tacrolimus 0.1% 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aisha salim 
Designation  Post graduate 
Affiliation  Father Muller Medical College Hospital 
Address  Father Muller Medical College Hospital Kankanady, Manglore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9567327972  
Fax    
Email  maahyt12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rochelle monteiro 
Designation  Professor 
Affiliation  Father Muller Medical College Hospital 
Address  Father Muller Medical College Hospital Kankanady, Manglore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9739315324  
Fax    
Email  rochelle@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Dr Aisha salim 
Designation  Post graduate 
Affiliation  Father Muller Medical College Hospital 
Address  Father Muller Medical College Hospital Kankanady, Manglore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9567327972  
Fax    
Email  maahyt12@gmail.com  
 
Source of Monetary or Material Support  
Self funded Dr Aisha Salim Father Muller Medical College Hospital Kankanady, Manglore Karnataka, India 575002 
 
Primary Sponsor  
Name  Dr Aisha Salim 
Address  Father Muller Medical College Hospital Kankanady, Manglore Karnataka 575002 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR AISHA SALIM  Father Muller Medical College Hospital  Department Of Dermatology No. 65 Opd Dakshina Kannada, Karnataka
Dakshina Kannada
KARNATAKA 		 9567327972

maahyt12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father muller Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with AD willing to participate and those with age 16 and more with the diagnosis of mild to moderate Atopic dermatitis on the basis of Hannifin and Rajka criteria. 
 
ExclusionCriteria 
Details  1. Patient on topical and systemic corticosteroid, Immunosuppressants , UVA and UVB therapy .
2. Patients with atopic dermatitis having other skin diseases.
3. Pregnant and lactating women
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate TEWL in adult patients with mild to moderate atopic dermatitis receiving topical crisaborole 2% and topical tacrolimus 0.1%
To evaluate the EASI score in adult patients with mild to moderate atopic dermatitis receiving topical crisaborole 2% and topical tacrolimus 0.1% 		 Baseline (day 0), week 2 and week 4. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Atopic dermatitis is a condition that causes dry, itchy and inflamed skin. It’s common in young children but can occur at any age. Atopic dermatitis is long lasting and tends to flare sometimes.
People with atopic dermatitis are at risk of developing food allergies, hay fever and asthma. Atopic dermatitis symptoms can appear anywhere on the body and vary widely from person to person. This condition can worsen. That’s why getting proper treatment soon after you notice signs and symptoms is so important. A treatment plan that’s customized to meet your needs can help prevent atopic dermatitis from worsening. In this study, we are going to observe two topical medications (Tacrolimus 0.1% and Crisaborole 2%) and how it improves the condition. This is measured using two scales. One Scoring method is used that includes physical assessment called as EASI score. The trans-epidermal water loss is the ability of your skin to hold on to water is measure using a device called as Vapometer. Using these two parameters, the efficacy and safety profiles of these two topical medications are assessed.
 
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