Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Barbara Rampersad

ORCID ID

Contact details

Central Manchester & Manchester Children's University Hospitals BH
Booth Hall Children's Hospital
Charlestown Road
Blackley
Manchester
M9 7AA
United Kingdom

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/11/2015: no publications found on PubMed.