Tacrolimus Versus Hydrocortisone in Atopic Dermatitis

NCT05324618 | Completed Phase 4

• 1 other identifier: Tacrolimus vs Hydrocortisone
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Atopic dermatitis (AD) is a very common inflammatory, genetic skin disorder that occurs more frequently in children. Its exact etiology is not known but it is characterized by pruritic skin reactions with elevation in the levels of inflammatory markers. Corticosteroids are the first line and the mainstay therapy in management of atopic dermatitis but have many local and systemic adverse effects. The study aims to evaluate the efficacy and safety of topical tacrolimus ointment in comparison to topical hydrocortisone cream in management of children diagnosed with atopic dermatitis.

Conditions

Atopic; Dermatitis

Keywords

Tacrolimus; Hydrocortisone; Atopic; Dermatits; children

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  4 months

• severity assessment

  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).

  4 months

Secondary Outcomes (4)

• evaluate the tacrolimus safety

  4 months

• evaluation of tacrolimus safety

  4 months

• evaluation of safety of tacrolimus

  4 months

• evaluate the hydrocortisone safety

  4 months

Study Arms (2)

Tacrolimus group

ACTIVE COMPARATOR

100 patients treated by thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months.

Drug: Tacrolimus

Hydrocortisone group

ACTIVE COMPARATOR

100 patients treated by thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months.

Drug: Hydrocortisone

Interventions

Tacrolimus DRUG

0.03% topical tacrolimus ointment applied on the affected areas twice daily for 4 months.

Also known as: Tacrolimus (Tacrolimus 0.03%®) was manufactured by AL-Andalous company for pharmaceutical and chemical industries, Egypt.

Tacrolimus group

Hydrocortisone DRUG

1% hydrocortisone cream applied on the affected areas twice daily for 4 months.

Also known as: Hydrocortisone (Micort 1%®) was manufactured by Cid company for pharmaceutical and chemical industries, Egypt.

Hydrocortisone group

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female patients
• years old
• diagnosed with Atopic Dermatitis according to Hanifin and Rajka criteria

You may not qualify if:

• patients with serious skin disorder other than Atopic Dermatitis
• patients taking systemic corticosteroids or anti-inflammatory medications.

Sponsors & Collaborators

• Ain Shams University: lead
• National Hepatology & Tropical Medicine Research Institute: collaborator

Study Sites (1)

Dermatology Clinic of National Hepatology and Tropical Medicine Research Institute

Cairo, 123456, Egypt

Location

Related Publications (4)

• Alaiti S, Kang S, Fiedler VC, Ellis CN, Spurlin DV, Fader D, Ulyanov G, Gadgil SD, Tanase A, Lawrence I, Scotellaro P, Raye K, Bekersky I. Tacrolimus (FK506) ointment for atopic dermatitis: a phase I study in adults and children. J Am Acad Dermatol. 1998 Jan;38(1):69-76. doi: 10.1016/s0190-9622(98)70541-9.

  PMID: 9448208 BACKGROUND

• Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x.

  PMID: 11168575 BACKGROUND

• Reitamo S, Rustin M, Ruzicka T, Cambazard F, Kalimo K, Friedmann PS, Schoepf E, Lahfa M, Diepgen TL, Judodihardjo H, Wollenberg A, Berth-Jones J, Bieber T; European Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. J Allergy Clin Immunol. 2002 Mar;109(3):547-55. doi: 10.1067/mai.2002.121832.

  PMID: 11898005 BACKGROUND

• Mohamed AA, El Borolossy R, Salah EM, Hussein MS, Muharram NM, Elsalawy N, Khalil MG, Mahmoud MO, El-Amir RY, Elsanhory HMA, Ahmed N, Adaroas AS, Montaser M, El Kholy AA. A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children. Front Pharmacol. 2023 Sep 20;14:1202325. doi: 10.3389/fphar.2023.1202325. eCollection 2023.

  PMID: 37799965 DERIVED

MeSH Terms

Conditions

Dermatitis

Interventions

Tacrolimus; Pharmaceutical Preparations; Chemical Industry; Hydrocortisone

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Amal A. Mohamed

  Department of Biochemistry, National Hepatology and Tropical Medicine Research institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, double blinded, simply randomized clinical trial

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: April 12, 2022
• Study Start: May 15, 2022
• Primary Completion: November 20, 2022
• Study Completion: April 30, 2023
• Last Updated: July 24, 2023

Record last verified: 2022-01

Locations

EG (1)