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Evaluating a novel nano-lipid formulation of curcumin-luteolin for the treatment of adults with moderate Eczema

A randomized, double-blinded, parallel-group Phase I/II clinical study evaluating the safety and efficacy of a nano-lipid formulation of curcumin-luteolin in adults with moderate atopic dermatitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260220001
Enrollment
95
Registered
2026-02-20
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Moderate Atopic Dermatitis (Eczema) Eczema Dermatitis Skin disorders Nanoparticles

Interventions

This formulation will act as the vehicle (placebo) control, matching the experimental gel in appearance, texture, color and The gel will be applied topically to affected areas twice daily for the dura
Aloe vera gel,Aloe vera Gel Containing Curcumin and Luteolin Nano-Lipid Formulation (Investigational Product),Ruxolitinib Gel

Sponsors

Muhammad Nawaz Sharif University of Agriculture
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Patients with pruritus Visual Analog Scale (VAS) score equal or greater than 3 2. Patients with Body Surface Area (BSA) involvement of 2 to 20 3. Patients with Investigators Static Global Assessment (ISGA) score of 2 to 3 and baseline Eczema 4. Area and Severity Index (EASI) score of 4 to 16 indicating mild-to-moderate disease 5. Patients with a history of atopic dermatitis of at least 6 months duration 6. Willingness to provide written informed consent 7. Participants who agree to discontinue the use of other topical or systemic skin treatments during the study period. 8. Participants who have not participated in a similar clinical investigation within the past four weeks

Exclusion criteria

Exclusion criteria: 1. Female subjects who are pregnant, lactating or planning to become pregnant during the study period. 2. A known history or present condition of allergic response and hypersensitivity to any herbal products. 3. Subjects Having bacterial or fungal acne 4. Subject participating in any other cosmetic or therapeutic trial. 5. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness. 6. Subject has participated in a clinical study within the last 30 days prior to entering this study.

Design outcomes

Primary

MeasureTime frame
Eczema Area and Severity Index (EASI) score 8 weeks Dermatology-trained investigators

Secondary

MeasureTime frame
Pruritus severity assessed using Visual Analog Scale (VAS) 8 weeks VAS recorded by participants using a 10-cm scale,ISGA score improvement 8 weeks Dermatology-trained investigators,Change in Body Surface Area involvement 8 weeks BSA assessed using rule of nines/palm method.,Dermatology Life Quality Index (DLQI). 8 weeks DLQI administered as validated questionnaire,Incidence, severity, and relationship of treatment-emergent adverse events and local skin reactions throughout the study period 8 weeks Dermatology-trained investigators

Countries

Pakistan

Contacts

Public ContactMuhammad Usman

Muhammad Nawaz Sharif University of Agriculture

muhammad.usman@mnsuam.edu.pk03004691582

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026