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Trial registered on ANZCTR


Registration number
ACTRN12618001704280p
Ethics application status
Submitted, not yet approved
Date submitted
10/10/2018
Date registered
16/10/2018
Date last updated
16/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Laser treatment of facial hirsutism in women with polycystic ovary syndrome (PCOS)
Scientific title
Laser treatment of facial hirsutism in women with polycystic ovary syndrome (PCOS): assessing its effect on quality of life
Secondary ID [1] 296075 0
nil
Universal Trial Number (UTN)
not applicable
Trial acronym
Linked study record
not applicable

Health condition
Health condition(s) or problem(s) studied:
Facial Hirsutism 309642 0
Polycystic ovary syndrome 309643 0
Condition category
Condition code
Skin 308445 308445 0 0
Dermatological conditions
Metabolic and Endocrine 308446 308446 0 0
Other endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Women with polycystic ovary syndrome and facial hirsutism will be treated by the Cutera excel HR laser for hair reduction. The treatment dose will be set according to the participant skin type. Participant will be followed-up for 8 treatments, each 4-6 weekly apart. The estimated follow-up period is estimated to be 9 to 12 months depending on the participant's treatment schedule.
Intervention code [1] 312412 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307423 0
Dermatology Life Quality Index
Timepoint [1] 307423 0
Data will be collected at baseline, after 3, 6 and 8 (primary endpoint) treatment sessions.
The analysis will be conduct 4-6 weeks after completion of 8 laser treatment sessions.
Secondary outcome [1] 351870 0
Participant's subjective hirsutism severity via a scale of 1-10 in a specifically designed questionnaire.
Timepoint [1] 351870 0
Data will be collected at baseline, after 3, 6 and 8 treatment sessions.
The analysis will be conduct 4-6 weeks after completion of 8 laser treatment sessions.
Secondary outcome [2] 351872 0
Objective hirsutism severity using modified Ferriman-Gallwey score and photographic hair count
Timepoint [2] 351872 0
Data will be collected at baseline, after 3, 6 and 8 treatment sessions.
The analysis will be conduct 4-6 weeks after completion of 8 laser treatment sessions.
Secondary outcome [3] 351873 0
Participant's self-esteem using Rosenberg's Self-Esteem Scale
Timepoint [3] 351873 0
Data will be collected at baseline, after 3, 6 and 8 treatment sessions.
The analysis will be conduct 4-6 weeks after completion of 8 laser treatment sessions.
Secondary outcome [4] 351874 0
Participants anxiety and depression scores using Hospital Anxiety and Depression Scale
Timepoint [4] 351874 0
Data will be collected at baseline, after 3, 6 and 8 treatment sessions.
The analysis will be conduct 4-6 weeks after completion of 8 laser treatment sessions.
Secondary outcome [5] 351875 0
Hair-free interval after laser therapy via a specifically designed questionnaire.
Timepoint [5] 351875 0
Data will be collected at baseline, after 3, 6 and 8 treatment sessions.
The analysis will be conduct 4-6 weeks after completion of 8 laser treatment sessions.
Secondary outcome [6] 352838 0
Frequency of hair removal after laser therapy via a specifically designed questionnaire.
Timepoint [6] 352838 0
Data will be collected at baseline, after 3, 6 and 8 treatment sessions.
The analysis will be conduct 4-6 weeks after completion of 8 laser treatment sessions.

Eligibility
Key inclusion criteria
• Women with polycystic ovary syndrome
• Patient with troublesome facial hirsutism
• Patient who never had laser hair reduction to the face
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Women without PCOS
• Non-facial hirsutism only
• Contraindication to laser photoepilation (e.g. previous adverse events, skin cancer, pregnancy)
• Presence of other skin conditions at the intended treatment area
• Patient who had previous laser hair reduction treatment to the face
• Patient who last had laser hair reduction to the body =24 months ago

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size is calculated based on the minimal clinically important difference (MCID) in Dermatology Life Quality Index (DLQI) tool which was determined to be 3 to 5 in a previous study. To detect a mean difference of 5 based on a mean DLQI score of 11.8 (standard deviation 8.4) in women with hirsutism, a sample size of 23 would be required for a power of 80% and level of significance set at 5%. Assuming that 20% will be lost to follow-up, a minimum of 28 patients will be required for this study.

Continuous explanatory variables will be presented as means with standard deviations for normally distributed data or as medians with interquartile ranges for non-normally distributed data. Categorical explanatory variables will be presented as percentages. Differences in variables at baseline between subgroups of the study population will be tested using univariable regression or the Chi-squared test. P-values of <0.1 on univariate analyses will be interpreted as statistically significant. All p-values will be calculated from two-tailed tests of statistical significance with a type 1 error rate of 5%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2018
Actual
Date of last participant enrolment
Anticipated
30/08/2019
Actual
Date of last data collection
Anticipated
28/08/2020
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11841 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 23979 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 300666 0
Hospital
Name [1] 300666 0
Monash Medical Centre
Country [1] 300666 0
Australia
Primary sponsor type
University
Name
Monash Centre for Health Research and Implementation
Address
43-51 Kanooka Grove, Clayton, VIC 3168, Australia
Country
Australia
Secondary sponsor category [1] 300183 0
None
Name [1] 300183 0
Not applicable
Address [1] 300183 0
Not applicable
Country [1] 300183 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301448 0
Monash Health Human Research Ethic Committee
Ethics committee address [1] 301448 0
Ethics committee country [1] 301448 0
Australia
Date submitted for ethics approval [1] 301448 0
20/08/2018
Approval date [1] 301448 0
Ethics approval number [1] 301448 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87038 0
Dr Anju Joham
Address 87038 0
Monash Centre for Health Research and Implementation
43-51 Kanooka Grove,
Clayton,
VIC 3166
Country 87038 0
Australia
Phone 87038 0
+61 (03) 8572 2661
Fax 87038 0
Email 87038 0
anju.joham@monash.edu
Contact person for public queries
Name 87039 0
Chau Thien Tay (Jillian)
Address 87039 0
Monash Centre for Health Research and Implementation
43-51 Kanooka Grove,
Clayton,
VIC 3166
Country 87039 0
Australia
Phone 87039 0
+61 (03) 8572 2661
Fax 87039 0
Email 87039 0
chau.tay@monash.edu
Contact person for scientific queries
Name 87040 0
Anju Joham
Address 87040 0
Monash Centre for Health Research and Implementation
43-51 Kanooka Grove,
Clayton,
VIC 3166
Country 87040 0
Australia
Phone 87040 0
+61 (03) 8572 2661
Fax 87040 0
Email 87040 0
anju.joham@monash.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.