Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® Regimen (COPES)

Hyphens Pharma

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: Ceradan Wash; Other: Ceradan Cream

Study type: Observational

Funder types: Industry

Identifiers

NCT02073591

HYP2013/001

Details and patient eligibility

About

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.

Full description

All eligible patients shall apply permitted topical steroid(s) according to standard local practice

For the entire study period, patients should apply Ceradan Cream® liberally twice daily or more, if required and use a non-soap based wash once or twice daily.

At the screening visit, patients will receive a diary card and will be asked to track their atopic dermatitis symptoms for 12 weeks.

Retrospective information on other topical treatments used will be collected at baseline.

Enrollment: 58 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• History of severe episodes of atopic dermatitis (for example: oozing, crusts)

• Clinical signs of skin infection (viral, bacterial or fungal)

• Grading of >11 as defined by the Nottingham Eczema Severity Score (NESS) within 3 months prior to study inclusion

• 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

Trial design

58 participants in 1 patient group

Ceradan Regimen

Description:

Ceradan Cream and Ceradan Wash

Treatment:

Other: Ceradan Cream

Other: Ceradan Wash