Atopic Dermatitis
Conditions
Keywords
Dermatitis, atopic, tacrolimus, Calcineurin inhibitors, crisaborole
Brief summary
This randomized controlled trial compares the effectiveness and safety of topical tacrolimus 0.03% and crisaborole 2% in patients with mild to moderate atopic dermatitis over 8 weeks. Atopic dermatitis is a chronic inflammatory skin condition affecting quality of life, and steroid-sparing treatments are increasingly preferred due to adverse effects of long-term corticosteroid use. Tacrolimus, a calcineurin inhibitor, and crisaborole, a PDE-4 inhibitor, are both effective alternatives, though tacrolimus may offer greater efficacy while crisaborole has better tolerability. The study will include 70 patients aged 2-20 years, randomized into two groups receiving either treatment. Outcomes will be assessed using EASI score reduction and adverse effects. Data will be analyzed statistically to determine significance. The study aims to generate local evidence to guide treatment decisions and improve management strategies for atopic dermatitis in the Pakistani population.
Detailed description
This randomised controlled trial is designed to evaluate and compare the effectiveness and safety of two commonly used steroid-sparing topical therapies-tacrolimus 0.03% and crisaborole 2%-in patients with mild to moderate atopic dermatitis over an 8-week period. Atopic dermatitis is a chronic inflammatory condition marked by itching, dryness, and recurrent eczematous lesions, often resulting from a combination of impaired skin barrier function and immune dysregulation. While topical corticosteroids are widely used, their long-term adverse effects have led clinicians to increasingly rely on alternative agents such as calcineurin inhibitors and PDE-4 inhibitors. In this study, patients aged 2 to 20 years meeting the inclusion criteria will be enrolled and allocated into two treatment groups through randomization. One group will receive tacrolimus 0.03% ointment, while the other will receive crisaborole 2%, both applied twice daily. Baseline data including demographic details, disease duration, EASI score, and pruritus severity will be recorded, followed by reassessment at weeks 4 and 8. The primary measure of effectiveness will be the reduction in EASI score, while safety will be evaluated based on the frequency and type of adverse effects such as burning or irritation. Statistical analysis will be conducted using appropriate tests to compare outcomes between groups. The study aims to generate locally relevant evidence to guide clinical decision-making, with the expectation that tacrolimus may demonstrate superior efficacy, while both treatments maintain acceptable tolerability profiles.
Interventions
DRUGTacrolimus
Tacrolimus 0.03% ointment applied twice daily to affected areas for 8 weeks. Tacrolimus is a topical calcineurin inhibitor that reduces T-cell activation and inflammatory cytokine release, improving eczema severity. Outcomes (EASI score, pruritus VAS, adverse effects) assessed at baseline, Week 4, and Week 8.
Crisaborole 2% ointment applied twice daily to affected areas for 8 weeks. Crisaborole is a topical phosphodiesterase-4 inhibitor that modulates inflammatory pathways and restores skin homeostasis. Outcomes (EASI score, pruritus VAS, adverse effects) assessed at baseline, Week 4, and Week 8.
Sponsors
Foundation University Islamabad
Fauji Foundation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study is assessor-blinded: participants and caregivers are aware of the assigned treatment (tacrolimus 0.03% or crisaborole 2%), but the investigator evaluating outcomes (EASI score, pruritus VAS, and adverse effects) will be blinded to group allocation
Intervention model description
This is a parallel-group randomized controlled trial. Participants with mild-to-moderate atopic dermatitis will be randomly assigned to either tacrolimus 0.03% ointment or crisaborole 2% ointment, applied twice daily for 8 weeks. Each participant will remain in their assigned group throughout the study, and outcomes-including EASI score, pruritus, and adverse effects-will be assessed at baseline, Week 4, and Week 8 to compare the effectiveness and safety of the two treatments.
Eligibility
Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
Age 2-20 years Clinically diagnosed mild to moderate AD EASI score ≤21 Informed consent
Exclusion criteria
Severe AD (EASI \>21) Use of topical/systemic corticosteroids within 2 weeks Secondary infection Known drug hypersensitivity Immunocompromised state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean reduction In EASI score. | baseline to 8 weeks | Change in EASI score from baseline to Week 8. Greater reduction indicates better disease control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety / Tolerability | throughout 8 weeks | Frequency of treatment-related adverse effects such as burning, stinging, erythema, or local irritation. |
Countries
Pakistan
Contacts
CONTACTSana Khan, FCPS, Fellowship in Derma
CONTACTDr. Asma Javed, FCPS Derma
STUDY_DIRECTORDr. Arfan ul Bari, FCPS Derma
Foundation University Islamabad
Outcome results
None listed