NCT02073591

Brief Summary

This is a prospective, open label, single arm, and observational and multicenter study to assess the correlation between PEST and SCORAD scores in the management of AD with the Ceradan® regimen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

February 19, 2014

Last Update Submit

November 4, 2015

Conditions

Atopic Dermatitis

Keywords

ChildrenAtopic DermatitisCeradanPESTSCORAD

Outcome Measures

Primary Outcomes (1)

  • Correlation between the mean Patient Eczema Severity Time (PEST) score and mean Scoring Atopic Dermatitis (SCORAD) Index at Week 4 and Week 12, as compared to baseline

    Correlation will be assessed by Pearson correlation at baseline, Week 4 and Week 12 between both scores. Karl Pearson correlation coefficient (ρ) will be provided. Percent Change from Baseline will be calculated for Week 4 and Week 12 and correlation will also be calculated for it.

    12 weeks

Secondary Outcomes (2)

  • Efficacy by change in SCORAD score at Week 4 and Week 12 as compared to baseline

    12 weeks

  • Efficacy by change in AUC PEST score at Week 4, Week 12 as compared to baseline and three months prior to baseline

    12 weeks

Study Arms (1)

Ceradan Regimen

Ceradan Cream and Ceradan Wash

Other: Ceradan CreamOther: Ceradan Wash

Interventions

Ceradan CreamOTHER
Ceradan Regimen
Ceradan WashOTHER
Ceradan Regimen

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children Aged Six Months to Six Years with Atopic Dermatitis

You may qualify if:

  • Male and female children aged ≥6 months to ≤6 years
  • Baseline PEST score of 3- 4
  • Diagnosis of mild to moderate atopic dermatitis, with grading of 3 to11, as per the NESS
  • Diagnosis of current flare (increased dryness, itching, redness, swelling and general irritability) at baseline visit according to Investigator's judgement
  • Patients who have not visited the dermatologist before (dermatologist-naïve)
  • Agree to participate and provide written consent by parent or guardian (and assent if applicable)

You may not qualify if:

  • History of severe episodes of atopic dermatitis (for example: oozing, crusts)
  • Clinical signs of skin infection (viral, bacterial or fungal)
  • Known reaction or allergy to test drug or excipients or steroids
  • History of cutaneous or systemic viral (including HIV or AIDS), cutaneous mycotic or cutaneous bacterial disease requiring a topical or systemic therapy during the study period
  • Patients who are receiving any investigational drug or who have taken part in a clinical study with an investigational drug within three months prior to the start of study treatment
  • The patient has been exposed to below therapy within the set timeframe:
  • i. Systemic administration of corticosteroid - four weeks; ii. Systemic administration of immunosuppressive drugs - four weeks; iii. UV therapy four weeks
  • Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
  • Parents/guardians may be unable to complete the patient diaries or questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KK Women's and Children's Hospital

Singapore, Singapore

Location

National Skin Centre

Singapore, Singapore

Location

Related Publications (1)

  • Koh MJ, Giam YC, Liew HM, Foong AY, Chong JH, Wong SMY, Tang MBY, Ho MSL, Tan LS, Mason JM, Cork MJ. Comparison of the Simple Patient-Centric Atopic Dermatitis Scoring System PEST with SCORAD in Young Children Using a Ceramide Dominant Therapeutic Moisturizer. Dermatol Ther (Heidelb). 2017 Sep;7(3):383-393. doi: 10.1007/s13555-017-0186-1. Epub 2017 Jun 14.

    PMID: 28616853DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 27, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

SG(2)