Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0453141246
Study information
Scientific title
Randomisation to topical corticosteroids or placebo for the treatment of the non-retractile foreskin
Acronym
Study hypothesis
To assess whether it is the corticosteroid alone or the gentle physical retraction combined with ointment that is responsible for the results previously observed with topical corticosteroid treatment of the non-retractile foreskin. Two steroid preparations are currently used within Manchester so the study will be carried out using both preparations to see if there is a significant difference between them.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Urological and Genital Diseases: Penile diseases
Intervention
Boys of 3 years and above who are referred to the outpatient clinic with a physiological non-retractile foreskin will be invited to participate in the study. The boys and their parent/carer will be interviewed by the primary investigator and given the patient information sheet. If they agree to participate in the study, written consent will be obtained. The patient will be randomised by the pharmacy department to receive either placebo, 1% hydrocortisone or 0.1% betnovate ointment. The parents will be instructed to apply the ointment to the tip foreskin every morning and evening for 6 weeks.
The patients will be assessed by the primary investigator after 6 weeks. If the treatment has been successful, ie. the foreskin is retractile, no further treatment is given. If the treatment has been unsuccessful, ie. partial or no retraction, the patients will be offered corticosteroid ointment (0.1% betnovate as this is the more potent steroid) for a further 6 weeks, following which time they will be reassessed. After 6 months all patients will be reassessed and foreskin retractility will be graded (full/partial/no retraction). The code for which ointment each patient used will be broken at the end of the study. All patients with persistent problems such as infection or a non-retractile foreskin at the end of the study period will be offered circumcision. All results will be recorded on data sheets in the patient's records and on a confidential database.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Retraction of the foreskin
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2002
Overall trial end date
01/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Boys of 3 years and over with a physiological non-retractile foreskin
Participant type
Patient
Age group
Child
Gender
Male
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2002
Recruitment end date
01/01/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Central Manchester & Manchester Children's University Hospitals BH
Manchester
M9 7AA
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Unfunded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list