Eczema Level: High Classification code 10014184
Conditions
Interventions
Product Name: Eczema cream
Product Code: HCP 20A
Pharmaceutical Form: Cream
INN or Proposed INN: Boswellia serrrata extract
Current Sponsor code: Secondary Product BS
Other descriptive name: Boswelli
Sponsors
Healthcare Product Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) male or female b) aged between 2 and 16 years c) diagnosis of atopic eczema d) sum of total affected Body Surface Area must be less than 60%. e) have used topical corticosteroid for eczema at least once in the last year. f) have not taken systemic agents for the past 4 weeks. g) have not taken topical steroids or topical immunosuppressants (Elidal, Protopic) for the past 3 days. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) abnormality in urine sample (routine - glucose, bilirubine, ketone, specific gravity, blood, pH, protein, Urobilinogen) b) abnormality in blood sample (routine – U & E’s and LFT’s) c) abnormality in blood pressure d) other clinically significant dermatological condition e) clinically significant concomitant illness f) taking systemic agents g) participation in a clinical trial of any investigational substance within 4 weeks of starting this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary outcome variables: Modified Medical Eczema Area and Severity Index EASI(1) change from baseline to end of treatment. Withdrawal due to worsening eczema. Follow up on relapse rate Secondary outcome variables: Patient and researcher global assessment of efficacy of treatment. Eczema, Sleep disturbance and Pruritis 100mm Visual Analogue Scale(2) Change in appearance of lesions from standardized photographs. ;Main Objective: To determine whether the cream HCP-20A is effective in treating atopic eczema.;Secondary Objective: To document all adverse events | — |
Countries
United Kingdom
Outcome results
None listed