Derma Cal Plus, herbal skin cream for children aged between 2 months to 5 years of age suffering from Eczema: A Double Blind Randomized Placebo Controlled Trial

ISRCTN ISRCTN28536368
DOI https://doi.org/10.1186/ISRCTN28536368
Protocol serial number 09
Sponsor Herba Naturelle Ltd
Funder Herba Naturelle Ltd
Submission date
01/06/2004
Registration date
07/06/2004
Last edited
19/02/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Vivek Wayse
Scientific

19 Lakehall Gardens
Thornton Heath
Surrey
CR7 7EL
United Kingdom

Phone +44 (0)20 8664 8720

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedEczema
InterventionTopical application of Derma Cal Plus cream or placebo.
Follow-up each month by questionnaire.
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Derma Cal Plus
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit5 Years
SexNot Specified
Key inclusion criteria1. Children less than 5 years of age
2. Children with mild or moderate atopic eczema within the past month
3. Children whose parent gives informed consent
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2003
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

19 Lakehall Gardens
Surrey
CR7 7EL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan