Study to check effect, safety and reoccurrence rate with Mometasone Furoate and Fluticasone propionate in children with dry, itchy and inflamed skin.

An open label, randomized, comparative study to evaluate effectiveness, safety and remission rate with Mometasone Furoate 0.1 percentage and Fluticasone propionate 0.05 percentage in children with Atopic Dermatitis - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087075

Enrollment

100

Registered

2025-05-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: L209- Atopic dermatitis, unspecified

Interventions

Intervention1: Mometasone Furoate 0.1% cream: Topical Mometasone 0.1 % Dosage Form: Cream Dosage: Once a day local application Treatment Duration: 4 weeks Control Intervention1: Fluticasone propionat

Eligibility

Inclusion criteria

Inclusion criteria: Patients eligible for enrolment in the study must meet all of the following criteria: 1. Male or Female subjects within age group of 03 months to 12 years with AD according to William s criteria or diagnosed as AD patient by the clinician with eczematous lesions. 2. Parent/guardian of child should give written parental consent for participation in study

Exclusion criteria

Exclusion criteria: 1. Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments. 2. Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results. 3. Subject has a known hypersensitivity to Mometasone, fluticasone or any of the excipients used in the formulation.

Design outcomes

Primary

Measure	Time frame
1. Percentage of patients with improvement in EASI-75 (75% improvement from baseline in the score on the EASI) from baseline to week 4. 2. Percentage of patients who achieved resolution in 4 weeks (IGA score of clear or almost clear or greater than or equal to 2 reduction from baseline) 3. Percentage of patients who suffered from relapse (Relapse is defined as recurrence of either of AD symptoms like erythema, edema, excoriation and lichenification) in week 20. Timepoint: 1) 4 weeks 2) 4 weeks 3) 20 weeks	—

Measure

Time frame

1. Percentage of patients with improvement in EASI-75 (75% improvement from baseline in the score on the EASI) from baseline to week 4. 2. Percentage of patients who achieved resolution in 4 weeks (IGA score of clear or almost clear or greater than or equal to 2 reduction from baseline) 3. Percentage of patients who suffered from relapse (Relapse is defined as recurrence of either of AD symptoms like erythema, edema, excoriation and lichenification) in week 20. Timepoint: 1) 4 weeks 2) 4 weeks 3) 20 weeks

—

Secondary

Measure	Time frame
1. Evaluation of Treatment Emergent Adverse Events 2. Evaluation of cutaneous tolerability of drugs like signs of cutaneous atrophy, epidermal thickening /lichenification and abnormal pigmentation changes 3.The incidences treatment related AEs shall be recorded by treating physicianTimepoint: Baseline to 4 weeks	—

Countries

India

Contacts

Public ContactDr Swetalina Pradhan

AIIMS Patna

drswetalinapradhan01@gmail.com06122451070

Outcome results

None listed

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