Tacrolimus Versus Hydrocortisone in Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT05324618|
Recruitment Status : Recruiting
First Posted : April 12, 2022
Last Update Posted : April 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Tacrolimus Drug: Hydrocortisone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||prospective, double blinded, simply randomized clinical trial|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||200 opaque envelopes will be numbered serially and the corresponding letter which denotes the allocation will be put according to the electronic randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the envelope will be opened and the patient will be allocated according to the letter inside.|
|Official Title:||A Comparative Clinical Trial to Evaluate the Efficacy and Safety of Tacrolimus Versus Hydrocortisone in Treatment of Children With Atopic Dermatitis|
|Estimated Study Start Date :||April 15, 2022|
|Estimated Primary Completion Date :||May 20, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Active Comparator: Tacrolimus group
100 patients treated by thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months.
0.03% topical tacrolimus ointment applied on the affected areas twice daily for 4 months.
Other Name: Tacrolimus (Tacrolimus 0.03%®) was manufactured by AL-Andalous company for pharmaceutical and chemical industries, Egypt.
Active Comparator: Hydrocortisone group
100 patients treated by thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months.
1% hydrocortisone cream applied on the affected areas twice daily for 4 months.
Other Name: Hydrocortisone (Micort 1%®) was manufactured by Cid company for pharmaceutical and chemical industries, Egypt.
- evaluate the effect of topical tacrolimus ointment as compared to topical hydrocortisone cream on the serum level of different inflammatory cytokines using enzyme linked immunosorbent assay technique (ELISA) [ Time Frame: 4 months ]estimation of the serum level of inflammatory cytokines (biochemical evaluation of IL-10 (pg/ml), IL-17 (pg/ml), IL-23 (pg/ml) using enzyme linked immunosorbent assay technique (ELISA)
- severity assessment [ Time Frame: 4 months ]Estimation of the effect on the dermatitis severity scale using the modified Eczema Area and Severity Index (mEASI) score. It is a tool used to evaluate the severity of eczema based on body surface area affected by lesions, morphology of lesions (erythema, papules, excoriation, and lichenification), severity of lesions (0-3), and pruritus. The scores range from 0 to 72 for the main symptoms of AD and from 0 to 18 for pruritus, giving a maximum possible score of 0 (no involvement) to 90 (maximum involvement), (0-0.9 clear, 1-8.9 mild, 9.0-29.9 moderate, 30.0-90 severe).
- evaluate the tacrolimus safety [ Time Frame: 4 months ]assessment of treatment related toxicities; assessment of the incidence rate of burning
- evaluation of tacrolimus safety [ Time Frame: 4 months ]assessment of other tacrolimus related toxicity; the incidence rate of stinging sensation
- evaluation of safety of tacrolimus [ Time Frame: 4 months ]assessment of the degree of erythema using Eczema Area and Severity Index (EASI). The EASI is a composite score comprising ratings of the severity of erythema, oedema/induration/papulation, excoriations and lichenification; each on a scale from 0 to 3.
- evaluate the hydrocortisone safety [ Time Frame: 4 months ]assessment of the incidence rate of skin atrophy and skin infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05324618
|Contact: Amal A. Mohamed, Prof.||+firstname.lastname@example.org|
|Contact: Amal A. Elkholyemail@example.com|
|Dermatology Clinic of National Hepatology and Tropical Medicine Research Institute||Recruiting|
|Cairo, Egypt, 123456|
|Contact: Amal A. Mohamed, Prof 01224847367 firstname.lastname@example.org|
|Principal Investigator:||Amal A. Mohamed||Department of Biochemistry, National Hepatology and Tropical Medicine Research institute|