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Trial registered on ANZCTR


Registration number
ACTRN12613000756729
Ethics application status
Approved
Date submitted
4/07/2013
Date registered
5/07/2013
Date last updated
9/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the efficacy, safety and tolerability of topically applied tretinoin formulated with TPM, a lead commercially available tretinoin cream and a vehicle (placebo) in the treatment of mild to moderate acne vulgaris
Scientific title
A Phase II, randomized, active and vehicle controlled, Investigator blind, multi-centre study to evaluate the efficacy, safety and tolerability of topically applied tretinoin formulated with TPM as an anti-acne preparation in human subjects with acne vulgaris.
Secondary ID [1] 282783 0
Nil
Universal Trial Number (UTN)
Trial acronym
POH031-13
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment of acne vulgaris 289546 0
Condition category
Condition code
Skin 289871 289871 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will receive tretinoin (0.05%) formulated with tocopheryl phosphate mixture (TPM), a commercially available tretinoin formulation (0.05%), or a vehicle (placebo), which will be applied once daily for 3 months. TPM is a delivery system derived from Vitamin E that is able to increase the dermal absorption of tretinoin without increasing irritation.

Each subject will be given written instructions entitled “Instructions for facial cleansing and study treatment application” that will outline the facial cleansing and study treatment application instructions.

The instructions are briefly summarised below:
1. Gently wash entire face with the supplied skin cleanser, rinse immediately, pat the face dry with a towel
2. Leave the skin for 20 - 30 minutes before applying study treatment.
3. 30 - 60 minutes before bed, squeeze about a centimetre of the assigned study treatment onto your fingertip (while that should be enough for your whole face, after you have some experience with the medication you may find you need slightly more or less to do the job).
4. Dabbing it on your forehead, chin and both cheeks, then spreading it over the entire face. Smooth gently into the skin. The medication should become invisible almost immediately. If it is still visible, or if dry flaking occurs from the gel within a minute or so, you are using too much.
5. Keep the medication away from the corners of the nose, mouth, eyes and open wounds.
6. Wash hands thoroughly after application of the study treatment.
7. Ensure product is absorbed prior to sleeping.
8. Leave treated areas undisturbed overnight.

Compliance will be monitored by use of a daily patient diary.
Intervention code [1] 287459 0
Treatment: Drugs
Comparator / control treatment
Subjects will receive tretinoin (0.05%) formulated with TPM, a commercially available tretinoin formulation (0.05%), or a vehicle (placebo), which will be applied once daily for 3 months.
Control group
Active

Outcomes
Primary outcome [1] 289934 0
The mean absolute change in total acne lesion count

Lesion count will be scored by a dermatologist during clinical examination.
Timepoint [1] 289934 0
From Baseline to Week 12.
Primary outcome [2] 289935 0
The percent of subjects with a successful outcome on a global acne grading scale.

Success on the Acne Global Severity Scale is a reduction of 2 from baseline.
Timepoint [2] 289935 0
Week 12.
Secondary outcome [1] 303596 0
The percent change in total acne lesion counts

Lesion count will be scored by a dermatologist during clinical examination.
Timepoint [1] 303596 0
Baseline to Week 2, 4, 6, 8, and 12
Secondary outcome [2] 303597 0
The percent change using a global acne grading scale.
Timepoint [2] 303597 0
Baseline to Week 2, 4, 6, 8, and 12.
Secondary outcome [3] 303599 0
The percent change in blackhead/whitehead lesion counts

Blackhead/whitehead lesion count will be scored by a dermatologist during clinical examination.
Timepoint [3] 303599 0
Baseline to Week 2, 4, 6, 8, and 12
Secondary outcome [4] 303600 0
The percent change in papules/pustules lesion counts

Papules/pustules lesion count will be scored by a dermatologist during clinical examination.
Timepoint [4] 303600 0
Baseline to Week 2, 4, 6, 8, and 12
Secondary outcome [5] 303601 0
The change in responses to acne self assessment questionnire
Timepoint [5] 303601 0
Baseline to Week 4 and Week 12
Secondary outcome [6] 303602 0
Comparison of location reaction between formulations

Irritation will be scored using the Local Reaction Grading Scale by a dermatologist during clinical examination.
Timepoint [6] 303602 0
Baseline to Week 2, 4, 6, 8, and 12
Secondary outcome [7] 303603 0
The percentage of treatment related Adverse Events
Adverse reactions reported with tretinoin are as follows:

The skin of certain sensitive individuals may become excessively red, oedematous, blistered or crusted. If this occurs, the medication should be either discontinued until the integrity of the skin is restored or the medication should be adjusted to a level the patient can tolerate.

Temporary hyperpigmentation or hypopigmentation has been reported with repeated application of tretinoin.

Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin. To date, all adverse effect of tretinoin have been reversible upon discontinuation of therapy.

Isolated occurrences of allergic contact dermatitis have been reported after treatment with tretinoin.

Reversible changes in liver function tests have been reported following topical use of tretinoin. Elevated serum levels of bilirubin, alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were observed, and thymol turbidity and thymol flocculation were increased.
Timepoint [7] 303603 0
Duration of Study (consent until follow up visit).

Follow up visit will occur during week 14.

Eligibility
Key inclusion criteria
* Minimum of 15 and Maximum of 60 inflammatory lesions on the face (papules and/ or pustules) and no more than one small nodulocystic lesion;
* Existence of a minimum of 50 non-inflammatory lesions on the face (blackheads/whiteheads);
* A score of 2 or 3 on the Investigator's Global Assessment (IGA) scale;
* Willing to minimise exposure to the sun, and avoid tanning booths and solariums
Minimum age
12 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Severe acne vulgaris
* Facial skin condition other than acne vulgaris
* Facial hair, excessive scarring, sunburn or other disfigurement that may obscure assessment of acne counts or severity
* History of retinoid intolerance
* Subjects that are on topical/systemic acne treatment that does not meet the washout period
* Nursing/pregnant women
* The women were planning for pregnancy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment outside Australia
Country [1] 5528 0
New Zealand
State/province [1] 5528 0
Hamilton

Funding & Sponsors
Funding source category [1] 287555 0
Commercial sector/Industry
Name [1] 287555 0
Phosphagenics
Address [1] 287555 0
11 Duerdin Street Clayton, Victoria 3168
Country [1] 287555 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics
Address
11 Duerdin Street Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 286306 0
None
Name [1] 286306 0
Address [1] 286306 0
Country [1] 286306 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289532 0
Bellberry Limited
Ethics committee address [1] 289532 0
229 Greenhill Road Dulwich South Australia 5065
Ethics committee country [1] 289532 0
Australia
Date submitted for ethics approval [1] 289532 0
Approval date [1] 289532 0
27/06/2013
Ethics approval number [1] 289532 0

Summary
Brief summary
A multi centre, investigator blind, study in a total of 45 subjects with mild to moderate acne vulgaris aiming to evaluate the efficacy, safety and tolerability of topical tretinoin formulated with TPM compared with a commercially available tretinoin formulation, and a vehicle.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41226 0
Dr Lynda Spelman
Address 41226 0
Specialist Connect
68 Ipswich Rd,
Woolloongabba, QLD, Australia 4102
Country 41226 0
Australia
Phone 41226 0
+61 7 3039 1300
Fax 41226 0
Email 41226 0
Kurt.davidson@uqconnect.edu.au
Contact person for public queries
Name 41227 0
Ms Alisha Smith
Address 41227 0
Phosphagenics Ltd
11 Duerdin Street
Clayton, VIC, Australia 3168
Country 41227 0
Australia
Phone 41227 0
+61 3 9565 1119
Fax 41227 0
Email 41227 0
asmith@phosphagenics.com
Contact person for scientific queries
Name 41228 0
Ms Alisha Smith
Address 41228 0
Phosphagenics Ltd
11 Duerdin Street
Clayton, VIC, Australia 3168
Country 41228 0
Australia
Phone 41228 0
+61 3 9565 1119
Fax 41228 0
Email 41228 0
asmith@phosphagenics.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary