Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256119282
Study information
Scientific title
Acronym
Study hypothesis
Does laser depilation affect the self-esteem and emotional well-being of Afro-Caribbean women with unwanted facial hair due to polycystic ovary syndrome? Does laser depilation affect the psychosocial behaviour of these patients?
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
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Skin and Connective Tissue Diseases: Hirsutism
Intervention
Randomised controlled and partially blinded study.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Improvement in quality of life, mood and self esteem is expected after a reduction in facial hair by laser treatment.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
20/12/2002
Overall trial end date
30/10/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
40 Patients and 40 controls.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
20/12/2002
Recruitment end date
30/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Dermatology
London
NW3 2QG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Free Hampstead NHS Trust (UK)
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
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15888157
Publication citations
-
Results
Clayton WJ, Lipton M, Elford J, Rustin M, Sherr L, A randomized controlled trial of laser treatment among hirsute women with polycystic ovary syndrome., Br. J. Dermatol., 2005, 152, 5, 986-992, doi: 10.1111/j.1365-2133.2005.06426.x.