CTRI

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CTRI Number

CTRI/2019/12/022332 [Registered on: 12/12/2019] Trial Registered Prospectively

Last Modified On:

03/12/2019

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A study to compare the effectiveness of oral fexofenadine combined with topical treatment vs topical treatment alone in treatment of childhood atopic dermatitis

Scientific Title of Study

A study to evaluate the effectiveness of adding an oral second generation, non sedating, H1 antihistamine (Fexofenadine) to topical treatment in achieving better clinical outcome in paediatric patients of atopic dermatitis

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Ningombam Aloka
Designation	Junior Resident
Affiliation	PGIMER Chandigarh
Address	Department of Dermatology, Venereology and Leprology PGIMER Chandigarh Room no. 438, 4th floor Kairon Administrative Block, PGIMER Chandigarh Chandigarh CHANDIGARH 160012 India
Phone	7005748613
Fax
Email	aloka.ning@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sanjeev Handa
Designation	Professor and Head of Department
Affiliation	PGIMER Chandigarh
Address	Department of Dermatology, Venereology and Leprology PGIMER Chandigarh Chandigarh CHANDIGARH 160012 India
Phone
Fax
Email	handa_sanjeev@yahoo.com

Details of Contact Person
Public Query

Name	Ningombam Aloka
Designation	Junior Resident
Affiliation	PGIMER Chandigarh
Address	Department of Dermatology, Venereology and Leprology PGIMER Chandigarh Room no. 438, 4th floor Kairon Administrative Block, PGIMER Chandigarh Chandigarh CHANDIGARH 160012 India
Phone	7005748613
Fax
Email	aloka.ning@gmail.com

Source of Monetary or Material Support

Department of Dermatology, PGIMER Chandigarh

Primary Sponsor

Name	PGIMER Chandigarh
Address	Department of Dermatology, PGIMER Chandigarh
Type of Sponsor	Research institution and hospital

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 Aloka Ningombam	PGIMER Chandigarh	Department of Dermatology, Venereology and Leprology Chandigarh CHANDIGARH	7005748613 aloka.ning@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, PGIMER Chandigarh	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: L20-L30\|\|Dermatitis and eczema,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Fexofenadine hydrochloride	Group A will receive oral fexofenadine with topical treatment for 8 weeks Group B will receive only topical treatment for 8 weeks
Comparator Agent	topical corticosteroids or topical calcineurin inhibitors	Group A will receive oral fexofenadine with topical treatment for 8 weeks Group B will receive only topical treatment for 8 weeks

Inclusion Criteria

Age From	6.00 Month(s)
Age To	14.00 Year(s)
Gender	Both
Details	Paediatric patients of atopic dermatitis between 6months to 14 years of age, irrespective of sex diagnosed as per the UK criteria Patients with mild to moderate disease Willing to come for regular follow up

ExclusionCriteria

Details

Patients with severe disease needing systemic therapy
Inability to come for follow up visits
Patients whose parents or guardians do not give valid consent

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
Mean difference in Scoring Atopic Dermatitis Index (SCORAD) between the two groups	0, 2, 4 and 8 weeks

Secondary Outcome

Outcome	TimePoints
Mean difference in 5 D Itch Score between the two groups Mean difference in pre and post treatment levels of serum interleukin 31	0, 2, 4 and 8 weeks 0 and 8 weeks

Target Sample Size

Total Sample Size="140"
Sample Size from India="140"
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)

16/12/2019

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="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

Atopic Dermatitis (AD)is a common, chronically relapsing inflammatory skin disease characterised by eczema and episodes of extreme pruritus that usually start in infancy and may progress into adulthood. AD treatments are mostly aimed at relieving inflammation with the use of topical corticosteroids and topical calcineurin inhibitors, and in more severe cases, systemic immunosuppressants. Oral antihistamines have traditionally been prescribed as adjuvant therapy with topical agents with the aim of relieving pruritus by antagonising the action of histamine on its cutaneous receptors. Nonetheless, their clinical efficacy is still disputed and it has been claimed that the role of antihistamines in AD management is essentially limited to their soporific effects.

Our study aims to compare the effectiveness of adding oral fexofenadine to topical treatment in paediatric patients of AD. We aim to quantify the response using clinical and serological markers. The study design will be an observer blinded, parallel group, comparative study wherein paediatric patients of mild to moderate AD will be randomized into two groups. The first group will receive appropriate topical treatment along with oral fexofenadine while the second group will receive topical treatment alone for a period of 8 weeks. All patients will be followed up to assess the improvement of clinical symptoms by the Scoring Atopic Dermatitis Index (SCORAD) and the 5 D Itch Score. Simultaneously, the pre and post treatment levels of interleukin 31 will be measured by ELISA to assess the effect of both treatment modalities on the inflammatory pathway.