Evaluating the Efficacy and Tolerability of Ceradan Advanced Cream in the Treatment of Children With Atopic Dermatitis

NCT05136261 | Unknown Phase 3 DMC

• 1 other identifier: HYP2021/001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Atopic dermatitis is the most common chronic inflammatory skin condition worldwide and in Singapore. There is a significant impact on the quality of life as well as psychosocial burden on the patient and family. Emollients are one of the cornerstones in the treatment of atopic dermatitis and are frequently prescribed with topical anti-inflammatories such as topical corticosteroids or topical calcineurin inhibitors to be used during active flares. Emollients that have additional anti-inflammatory properties may be able to reduce usage of topical corticosteroids or calcineurin inhibitors. In this study the investigators hope to evaluate the use of a patented ceramide dominant emollient which sustainably lowers the skin pH (Ceradan ® Advanced Cream, Hyphens Pharma, Singapore) with a commonly prescribed emollient in Singapore (Basic Aqua Cream, ICM Pharma, Singapore) for the treatment of moderate atopic dermatitis in children and adolescents.

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (2)

• Improvement in eczema severity and symptoms as determined by Eczema Area and Severity Index Score (EASI)

  0=clear; 0.1-1=almost clear; 1.1-7=mild; 7.1-21=moderate; 21.1-50=severe; 50.1-72=very severe

  2 weeks

• Improvement in eczema severity and symptoms as determined by Severity Scoring of Atopic Dermatitis score (SCORAD)

  The SCORAD score range is between 0 and 103 points and defines three classes of AD severity (i.e. mild if SCORAD \<25, moderate if 25 ≤ SCORAD ≤ 50 and severe if SCORAD \> 50)

  2 weeks

Secondary Outcomes (9)

• Changes in skin pH

  2 weeks

• Changes in skin transepidermal water loss (TEWL) using a TEWL meter

  2 weeks

• Changes in skin stratum corneum hydration

  2 weeks

• Changes in POEM (Patient Oriented Eczema Measures) score

  2 weeks

• Changes in PEST (Patient Eczema Severity Time) score

  2 weeks

Other Outcomes (2)

• Adverse reactions

  2 weeks

• Amount of topical steroids used

  2 weeks

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Ceradan Advanced Moisturising Skin Barrier cream - applied twice a day

Device: Ceradan ® Advanced Cream

Control

PLACEBO COMPARATOR

Aqueous Cream - applied twice a day

Device: Basic cream

Interventions

Ceradan ® Advanced Cream DEVICE

Ceradan ® Advanced Cream

Treatment

Basic cream DEVICE

Basic cream

Control

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and adolescents aged three to 16 years of age.
• Atopic dermatitis, in accordance with the U.K Working Party's Diagnostic Criteria.
• Moderate severity on both Eczema Area and Severity Index (EASI) and Scoring Atopic Dermatitis (SCORAD) scores. (I.e. 7.1-21 EASI and 29-48.9 SCORAD)
• Not currently infected eczema.
• Able to give informed consent or have a parent/guardian able and willing to give informed consent.

You may not qualify if:

• Known sensitivity or contact dermatitis to emollients, topical corticosteroids or any of its constituents.
• Currently infected eczema or frequent episodes of infected eczema requiring antibiotics.
• Currently on phototherapy, oral immunosuppressant, monoclonal antibodies for the treatment of eczema one month prior to start of study.
• Usage of any topical steroids or calcineurin inhibitors one week prior to start of study.
• Unable to give informed consent or have a parent/guarding unwilling to give consent.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Central Study Contacts

Colin Tan, M.B,B.S

CONTACT

+65 9787 0645; colin.tan.weixuan@kkh.com.sg

Mark Koh, M.B,B.S

CONTACT

+65 9689 2431; mark.koh.j.a@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Emollients will be dispensed in identical, unmarked containers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 29, 2021
• Study Start: January 10, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 29, 2021

Record last verified: 2021-10