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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022332
Enrollment
140
Registered
2019-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L20-L30- Dermatitis and eczema

Interventions

Intervention1: Fexofenadine hydrochloride: Group A will receive oral fexofenadine with topical treatment for 8 weeks Group B will receive only topical treatment for 8 weeks Control Intervention1: top

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Mean difference in Scoring Atopic Dermatitis Index (SCORAD) between the two groupsTimepoint: 0, 2, 4 and 8 weeks—

Secondary

MeasureTime frame
Mean difference in 5 D Itch Score between the two groups Mean difference in pre and post treatment levels of serum interleukin 31Timepoint: 0, 2, 4 and 8 weeks 0 and 8 weeks—

Countries

India

Contacts

Public ContactNingombam Aloka

PGIMER Chandigarh

handa_sanjeev@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026