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Evaluating the safety and efficacy of Nixoderm Tube in the treatment of atopic dermatitis in Adults.

A prospective, randomized, double blind, two arm, comparative clinical study to evaluate the safety and efficacy of Nixoderm tube for treating atopic dermatitis in adult subjects. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086123
Enrollment
40
Registered
2025-05-01
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: L20- Atopic dermatitis

Interventions

Intervention1: Nixoderm tube: Sufficient quantity of Nixoderm tube to be applied twice day at the site of Atopic Dermatitis,duration 30 days. Dosage form: Cream (Topical application) Control Interven

Sponsors

M/s.SC Johnson & Son Nigeria Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and Female volunteers aged between 18-60 years. 2. Participants diagnosed with of mild to moderate atopic dermatitis. 3. Willing to give Informed Consent 4. Willing to complete the study assessments/questionnaires. 5. Willing to avoid usage of his/her own skin care products in controlling atopic dermatitis for at least one week before the commencement and during this study.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breast feeding. 2. Patients with inflammatory or infective skin conditions. 3. Patients with history of hypersensitivity to skin care products. 4. Patients with mild to severe anaphylaxis reaction. 5. Patients with pre-existing severe systemic disease necessitating long-term medication. 6. Evidence of significant uncontrolled co-morbid disease which in the investigators opinion would jeopardize patient participation. 7. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ. 8. Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.

Design outcomes

Primary

MeasureTime frame
Primary outcomes: Percentage reduction in atopic dermatitis from baseline visit to last visit assessed by Atopic Dermatitis Severity Index (ADSI) and photographic evaluation. Percentage reduction of erythema, edema and papulation would be assessed through Eczema Area and Severity Index (EASI) from baseline to end of the study. Consumer feedback will be obtained via a set of subjective questionnaires to evaluate the response towards the productTimepoint: Day0,Day 7, Day 15, Day 30—

Secondary

MeasureTime frame
Secondary Outcomes: 1.Photographic Evaluation from baseline to all visits 3. Feedback Questionnaires from baseline to all visitsTimepoint: Day 7, Day 15, Day 30—

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt Ltd

surya.ashok@gmail.com09880999297

Outcome results

None listed

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