Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000476932
Ethics application status
Approved
Date submitted
6/05/2011
Date registered
9/05/2011
Date last updated
17/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Impact Of Two Different Patient Education Interventions On Patients' Perception Of Their
Appearance And On Their Medical Aesthetic
Treament Decision
Scientific title
The Impact Of Two Different Patient Education Interventions On Patients' Perception Of Their
Appearance And On Their Medical Aesthetic
Treament Decision - A prospective, randomised, controlled, observational pilot study
Secondary ID [1] 260117 0
Nil
Universal Trial Number (UTN)
U1111-1121-1691
Trial acronym
HOYS The Home Of Younger Skin
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Management of skin wrinkles and folds in the inevitable ageing process 265795 0
Condition category
Condition code
Skin 265968 265968 0 0
Normal skin development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The loss of bone and soft tissue, the redistribution of fat and decreased dermal elasticicy and thickness contribute to the formation of wrinkles and folds, all commonly characterise the inevitable ageing process.

A single formalised and reproducible consultation procedure, would empower the patient to make an informed treatment decision individualised to their specific needs.

The primary objective of this study is to prospectively evaluate the utility of a computer generated software program, compared to a standardised patient education intervention over a 9 week period. Both the education programs are administered at the Screening visit and then again at the week 9 visit, with the control arm being given the opportunity to complete the software at the completion of their W9 visits. Both education groups are assessed as to the impact of the subjects decision making on medical aesthetic treatments.

The software programme takes approximately 45 minutes for the subject to complete and the control group education intervention is administered in the form of an information sheet and is read by the subect and should take no longer that 20 minutes to read and comprehend.
Intervention code [1] 264532 0
Not applicable
Comparator / control treatment
A standard Patient Education Intervention was provided in the form of an infomation sheet with the subject asked to read this in a quiet room alone at the study site. This information sheet consisted of specific information on skin ageing in 7 specific skin areas,:- The forehead, the eye region, the cheek & nose region, the lower face region, the neck region, the chest region & the hands.
Control group
Active

Outcomes
Primary outcome [1] 266700 0
The primary objective of the study is to prospectively evaluate the utility of the software program compared to information relative to a standard patient education intervention.

The evaluation is based on a series of self-administered questionnaires, assessing satisfication with the allocated education intervention.
Timepoint [1] 266700 0
Baseline and Week 9
Primary outcome [2] 266704 0
Proportion of patients who achieve a 1 or 2 grade improvement based on the GAIS (Participant Self-Assessment of Global Aesthetic Improvement Scale).
Timepoint [2] 266704 0
Baseline and Week 9
Secondary outcome [1] 276215 0
Change from baseline in Patient's Self Perception of Age Scale (SPA)
Timepoint [1] 276215 0
Baseline and Week 9
Secondary outcome [2] 276222 0
Change from baseline in Patient's Facial Appearance Evaluation Scale (FAE)
Timepoint [2] 276222 0
Baseline and Week 9
Secondary outcome [3] 276223 0
Change from baseline in regional & skin scores for subjects recruited to computer software arm
Timepoint [3] 276223 0
Baseline and Week 9
Secondary outcome [4] 276224 0
Resource utilisation. was assessed by way of patients being able to make informed decisions of what medical aesthetic treatment they would undertake and the costs associated with this treatment dependant on what education intervention group they were assigned to on a monetary value.
Timepoint [4] 276224 0
Baseline and Week 9

Eligibility
Key inclusion criteria
Female subjects who are cosmetic/aesthetically oriented
Female subjects who are current aesthetic clients at the site for >12 months
Female subjects that agree that the enrolling clinic will be principal provider of services during the assessment period.
Female subjects who are intending to have medical aesthetic procedures during the study
Individuals who are classified as being either a "low" or "moderate" user of aesthetic services within the last 12 months defined as follows:-
Low - A single treatemnt cycle of BoNT-A and/or filler and/or lasers and/or IPS in the last 12 months
Moderate - 2 or more treatment cycles of BoNT-A and/or filler and/or lasers and/or IPL in the last 12 months
Minimum age
25 Years
Maximum age
54 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Males
Female subjects who have received facial filler, facial botulinum toxin or plastic surgery within 3 months of the study
Individuals who have had a reaction to medical aesthetic treatments
Females who plan to become pregnant during the study
Any medical conditon that the investigator deems that the subject would not be suitable to comply with the study

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3991 0
4169
Recruitment postcode(s) [2] 3992 0
2047
Recruitment postcode(s) [3] 3993 0
2000
Recruitment postcode(s) [4] 3994 0
5000
Recruitment postcode(s) [5] 3995 0
4740

Funding & Sponsors
Funding source category [1] 265020 0
Commercial sector/Industry
Name [1] 265020 0
Allergan Australia Pty Ltd
Country [1] 265020 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Allergan Australia Pty Ltd
Address
Level 4,
810 Pacific Highway,
GORDON NSW 2072
Country
Australia
Secondary sponsor category [1] 264115 0
None
Name [1] 264115 0
Address [1] 264115 0
Country [1] 264115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266998 0
Bellberrry Ethics Committee
Ethics committee address [1] 266998 0
Ethics committee country [1] 266998 0
Australia
Date submitted for ethics approval [1] 266998 0
Approval date [1] 266998 0
03/05/2010
Ethics approval number [1] 266998 0
c40/10b

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

Contacts
Principal investigator
Name 32574 0
Address 32574 0
Country 32574 0
Phone 32574 0
Fax 32574 0
Email 32574 0
Contact person for public queries
Name 15821 0
Nicole Johnston
Address 15821 0
Level 4
810 Pacific Highway
GORDON NSW 2072
Country 15821 0
Australia
Phone 15821 0
61 2 9498 0180
Fax 15821 0
61 2 9498 0292
Email 15821 0
[email protected]
Contact person for scientific queries
Name 6749 0
Michael Halstead
Address 6749 0
Level 4
810 Pacific Highway
GORDON NSW 2072
Country 6749 0
Australia
Phone 6749 0
61 2 9498 0167
Fax 6749 0
61 2 9498 0292
Email 6749 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIPatient's self-evaluation of two education programs for age-related skin changes in the face: a prospective, randomized, controlled study2011https://doi.org/10.2147/ccid.s23329
N.B. These documents automatically identified may not have been verified by the study sponsor.