A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone
Phase 2
Completed
- Conditions
- Dermatologic Disease
- Interventions
- Registration Number
- NCT05607901
- Lead Sponsor
- Tanta University
- Brief Summary
One of the most frequent skin conditions is atopic dermatitis (AD), characterized by its pruritic inflammation effect. Where the prevalence of AD increased in the last three decades by two or three folds worldwide, especially in developed countries, AD is supposed to affect about 15% to 30% of children, and 2% to 10% of adults. This type of dermatitis is frequently linked to a family history of other atopic illnesses such as allergic rhinitis or asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Male or female, 2-16 years old AD patients.
Exclusion Criteria
- patients diagnosed with other skin disorders of serious type and who are taking systemic corticosteroids or anti-inflammatory medications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tacrolimus Group Tacrolimus ointment 50 patients will be treated with a thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months. Hydrocortisone Group Hydrocortisone 1% cream 50 patients will be treated with a thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months.
- Primary Outcome Measures
Name Time Method To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood. 4 months To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood such as interleukin-6 (IL-6), and IL-10.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tanta Unuversity
🇪🇬Tanta, Egypt