Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis

ConditionsDermatitis, Atopic Eczema

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age5-25

SponsorCairo University

About this trial

This study will compare the efficacy and safety of crisaborole ointment with tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with diagnosis of AD, according to Hanifin and Rajka criteria.

Patients of both genders

Age 5-25 years

Baseline Investigator's Static Global Assessment (ISGA) score of mild (2) or moderate (3).

Disqualifiers

Clinically infected eczema.

Baseline Investigator's Static Global Assessment (ISGA) score of severe (4).

Associated comorbidities that exacerbate pruritus.

Patients receiving topical treatment for AD and/or pruritus within the past 14 days and/or systemic treatment within the past month.

Trial design

Design model

Parallel

Treatments tested in this trial

Application of crisaborole twice daily
Drug
compare the efficacy and safety of crisaborole ointment on mild to moderate atopic dermatitis for 1 month and followup in 2 months
Tacrolimus ointment in atopic dermatitis
Drug
compare the efficacy and safety of tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Crisaborole ointmentActive comparator 1 intervention

Group B: Tacrolimus ointmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

Improvement of Investigator's Static Global Assessment score

1. Assessment of the \*\*Investigator's Static Global Assessment\*\* scores before and after treatment with crisaborole 2% ointment. 2. Assessment of the \*\*Investigator's Static Global Assessment\*\* before and after treatment with tacrolimus 0.03% ointment. 3. Comparison of the \*\*percentage of improvement\*\* in the \*\*Investigator's Static Global Assessment\*\* between the two treatment groups.

Time frame

3 months

Improvement of Eczema Area and Severity Index

1. Assessment of \*\*Eczema Area and Severity Index\*\* scores before and after the use of \*\*crisaborole 2% ointment\*\*. 2. Assessment of \*\*Eczema Area and Severity Index\*\* scores before and after the use of \*\*tacrolimus 0.03% ointment\*\*. 3. Comparison of the percentage of improvement in the \*\*Eczema Area and Severity Index\*\* scores between the two treatment groups

Time frame

3 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: