| CTRI Number |
CTRI/2024/05/066965 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of locally applied tacrolimus, crisaborole and mometasone in patients aged more than 2 years with mild to moderate atopic dermatitis.
|
|
Scientific Title of Study
|
Efficacy, safety and economic analysis of topical preparations in patients with mild to moderate atopic dermatitis AD: a randomized open-labelled active controlled trial
|
| 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 Pradeep Dwivedi |
| Designation |
Additional Professor, Department of Pharmacology, AIIMS, Jodhpur |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Room No:232, 2nd floor, Department of Pharmacology,
AIIMS Jodhpur, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996952 |
| Fax |
|
| Email |
dr.prad99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Dodiya |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Room no: 250, 2nd floor, Department of Pharmacology, AIIMS, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7572813971 |
| Fax |
|
| Email |
dodiyarakesh2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Dodiya |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Room no: 250, 2nd floor, Department of Pharmacology, AIIMS, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7572813971 |
| Fax |
|
| Email |
dodiyarakesh2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur, Rajasthan, India, 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
AIIMS Jodhpur, 2nd Phase MIA 1st phase, Basni, Jodhpur,
Rajasthan, India, 342005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Dodiya |
All India Institute of Medical Sciences, Jodhpur |
Department Pharmacology, AIIMS
Jodhpur,
Department of Dermatology, Venereology and Leprology,
AIIMS Jodhpur
Jodhpur
RAJASTHAN |
7572813971
dodiyarakesh2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical Trial), All india institute of medical sciences, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Crisaborole |
Topical 2% Crisaborole applied twice a day for 4 weeks |
| Comparator Agent |
Mometasone |
Topical 0.1% Mometasone applied twice a day for 4 weeks |
| Comparator Agent |
Tacrolimus |
Topical age-appropriate dose of Tacrolimus applied twice a day for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Non-immunocompromised males or females aged 2 years or older with a clinical diagnosis of mild to moderate Atopic Dermatitis
2.An IGA of disease severity of at least mild to moderate at baseline (a score of 2 or 3)
|
|
| ExclusionCriteria |
| Details |
1.Pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
2.History of any confounding skin conditions
3.History or presence of HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders
4.Use within 14 days of baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin D preparations, or 3) retinoids or 4) study drugs
5.Known allergy or hypersensitivity to study drugs
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Proportion of patients with treatment success (a score of 0 or 1 within the treatment area) based on the Investigator’s Global Assessment of Disease Severity (IGA) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis |
2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Change from baseline to 4 weeks in IGA (investigators global assessment) score with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis |
2 weeks and 4 weeks |
| To evaluate the Change from baseline to 4 weeks in PP-NRS (Peak Pruritus Numerical Rating Scale) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis |
2 weeks and 4 weeks |
| To evaluate the Change from baseline to 4 weeks in EASI (Eczema area and severity index) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis |
2 weeks and 4 weeks |
| To evaluate the Change from baseline to 4 weeks in SCORAD (Scoring Atopic Dermatitis) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis |
2 weeks and 4 weeks |
| To evaluate the Change from baseline to 4 weeks in QoL (Quality of life) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis |
2 weeks and 4 weeks |
| To evaluate the cost-effectiveness for the proportion of patients with treatment success (a score of 0 or 1 within the treatment area) based on the Investigator’s Global Assessment of Disease Severity (IGA) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis |
2 weeks and 4 weeks |
| To evaluate the cost-utility based on quality of life with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis |
2 weeks and 4 weeks |
| To evaluate the Adverse events in each arm, coded as per MedDRA, with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis |
2 weeks and 4 weeks |
| To assess the number of patients needed the rescue medicine therapy after 2 weeks of treatment |
2 weeks and 4 weeks |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="26" |
|
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, also called atopic eczema, is a
persistent inflammatory condition involving skin, characterized by recurring
periods of exacerbation and improvement, impacting approximately 10%
individuals at some point in their lives. Atopic dermatitis arises from a
multifaceted mechanism involving immune system dysfunction, genetic mutations
in the epidermis, and environmental influences. This interaction disrupts the
skin’s outer layer, leading to the development of intensely itchy skin lesions.
Topical
corticosteroids (TCSs) are frequently employed as the primary therapeutic
approach for treating atopic dermatitis, but their safety profile is a matter
of concern on long term use. Tacrolimus is a topically used inhibitor of calcineurin
that specifically hinders the activation of T cells and mast cells. Prescribers
frequently suggest Tacrolimus as the initial treatment for atopic dermatitis in
sensitive skin areas. Crisaborole 2% - the topically used inhibitor of PDE-4
approved for AD – has only been tested against placebo, and not against active
treatment arms yet. There is
lack of comparative efficacy, safety, and economic analysis among TCS, Tacrolimus
and Crisaborole in patients presenting with mild to moderate AD.
90 patients will be enrolled with mild to moderate Atopic
dermatitis and they will be randomized in ratio of 1:1:1 to topical age-appropriate
dose of Tacrolimus group, topical 2% Crisaborole group and active control group
of topical 0.1% Mometasone. Each group will be followed up after 2 weeks, and
after 4 weeks for assessment of the efficacy, safety and economical outcomes.
|