Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000140459
Ethics application status
Approved
Date submitted
8/02/2007
Date registered
23/02/2007
Date last updated
17/11/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 2, 'Proof of Principle', Placebo Controlled, Randomised, Parallel Group Pilot Study of the Effect of a New Combined Acne Treatment in Patients with Mild to Moderate Acne.
Scientific title
Pilot study in patients with mild to moderate acne utilising a facial cleanser, topical gel and oral supplement compared to placebo for treatment of acne.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to Moderate Acne vulgaris 1634 0
Condition category
Condition code
Skin 1742 1742 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three products will be used twice daily in the trial. A topical gel containing nicotinamide (4% w/w) and sandalwood oil (2% w/w) as the actives, a cosmetic facial cleanser and an oral supplement containing a combination of vitamins and minerals (Zinc 12.5mg, Nicotinamide 25mg, Vitamin B6 25mg Vitamin E 25IU, Vitamin C 125mg, Linseed oil 250mg and Vitamin A 1250IU). Products will be used twice daily i.e. Face will be cleansed with facial cleanser, topical gel will be applied to affected area and 1x capsule will be taken. This process is repeated twice daily i.e. morning and night. These products will be compared against matching placebos i.e. identical formulations as the treatment minus the actives. There will be 2 treatment groups- active and placebo. Active group will take Active topical gel, Active facial cleanser and Active oral supplement.
Intervention code [1] 1589 0
Treatment: Drugs
Comparator / control treatment
Placebo group will take Placebo topical gel, Placebo facial cleanser and Placebo oral supplement. Trial duration is 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 2429 0
Two grade improvement in Investigators Global Assessment (IGA)
Timepoint [1] 2429 0
Determined at 0, 4, 8 and 12 weeks.
Secondary outcome [1] 4197 0
Reduction in Inflammatory Lesion Count
Timepoint [1] 4197 0
Determined at 0, 4, 8 and 12 weeks.

Eligibility
Key inclusion criteria
Subjects with mild to moderate inflammatory acne; of any racial/ethnic group.
Minimum age
15 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Oral retinoid use within 2 years of entry into the study; Systemic acne therapies within 4 weeks of entry into the study; Subjects with predominantly comedonal acne; Subjects with predominant retention acne.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
eligible patients will be randomised to the study using sequentially numbered dealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To allocate the patients into different groups a Binomial distribution random number generator was used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Double blind, subjects and investgator/assessor are blinded.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1891 0
Commercial sector/Industry
Name [1] 1891 0
LifeSource Group Holdings Pty Ltd.
Country [1] 1891 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
LifeSource Group Holdings Pty Ltd
Address
29-31 Solent Cct Baulkham Hills NSW 2153
Country
Australia
Secondary sponsor category [1] 1710 0
None
Name [1] 1710 0
Nil
Address [1] 1710 0
Country [1] 1710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3516 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 3516 0
PO Royal Melbourne Hospital
Parkville Victoria 3050
Ethics committee country [1] 3516 0
Australia
Date submitted for ethics approval [1] 3516 0
01/02/2007
Approval date [1] 3516 0
12/06/2007
Ethics approval number [1] 3516 0
2007.032

Summary
Brief summary
This is a pilot study to test in a small number of patients a holistic approach to acne treatment utilising a facial cleanser and topical gel treatment combined with an oral supplement combining natural ingredients which should not cause local irritation or lead to resistant organisms. The unique combination of natural ingredients aims to both cleanse the skin and target internal factors that will assist to promote healthy skin and to help alleviate acne. The Sponsor is looking to develop a suitable natural alternative to currently available pharmaceutical products for the treatment of mild to moderate acne.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27523 0
Address 27523 0
Country 27523 0
Phone 27523 0
Fax 27523 0
Email 27523 0
Contact person for public queries
Name 10778 0
Nadine Ismiel
Address 10778 0
Suite 402
29-31 Solent Cct
Baulkham Hills NSW 2153
Country 10778 0
Australia
Phone 10778 0
+61 2 88509444
Fax 10778 0
+61 2 88509445
Email 10778 0
nadine@lifesourcegroup.com
Contact person for scientific queries
Name 1706 0
Professor George Varigos
Address 1706 0
Department of Dermatology
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 1706 0
Australia
Phone 1706 0
+61 3 93474233
Fax 1706 0
Email 1706 0
george.varigos@mh.org.au

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.