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Trial registered on ANZCTR


Registration number
ACTRN12613000333718
Ethics application status
Approved
Date submitted
15/03/2013
Date registered
26/03/2013
Date last updated
11/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical Acitretin for the Treatment of rough scaly spots of sun-damaged skin or premalignant condition of thick, scaly, or crusty patches of sun-damaged skin (Facial Actinic Keratosis).
Scientific title
A Double-blind Randomised Placebo-controlled Study of Topical Acitretin and Placebo for the Treatment of Facial Actinic Keratosis.

Protocol Number: DP-001
Secondary ID [1] 281224 0
Nil
Universal Trial Number (UTN)
U1111-1134-5593
Trial acronym
ATAK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Facial actinic keratoses 287412 0
Condition category
Condition code
Skin 287746 287746 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomised to receive topical acitretin or placebo for 24 weeks. About 1g of Acitretin 0.25% w/w or 0.5% w/w will be applied once daily to the face. A three week follow-up for all participants occurs at the completion of the treatment phase. The dose concentration is determined by randomisation.
Intervention code [1] 285690 0
Treatment: Drugs
Comparator / control treatment
Placebo moisturiser gel applied once daily for 24 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 287982 0
Comparison of the partial clearance rates for each treatment group. The proportion of participants with 75 % or greater reduction of the number of AK Lesions on the face at the end of treatment compared to baseline. Measured by clinical assessment by the Principal Investigator or Sub-Investigator (lesion count).
Timepoint [1] 287982 0
24 weeks
Secondary outcome [1] 299177 0
Comparison of the total number of all visible or palpable AKs on the entire face at the end of treatment (i.e. those present at baseline and any new lesions) for each treatment group, measured by clinical assessment by the Principal Investigator or Sub-Investigator (lesion count).
Timepoint [1] 299177 0
24 weeks
Secondary outcome [2] 299178 0
Comparison of the change in the EIS Score for the entire face by treatment group compared with baseline.
Timepoint [2] 299178 0
Weeks 8, 16, and 24/end of treatment

Eligibility
Key inclusion criteria
- At least 3, to a maximum of 25, visible or palpable AK lesions on the face determined by clinical diagnosis.

- Males, or postmenopausal/surgically sterile females.

- Willing and able to comply with the protocol and study requirements.
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Atypical AK on the face.

- Diagnosis of SBCC on the face.

- Treatment with oral acitretin.

- Treatment with 5FU, imiquimod, diclofenac, PEP005 or topical retinoids on the face.

- Treatment with a dermatological procedure or surgery on the face.

- Other potentially confounding skin disorders on the face.

- Females of child bearing potential.

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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
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 outside Australia
Country [1] 4555 0
New Zealand
State/province [1] 4555 0
Bay of Plenty
Country [2] 4556 0
New Zealand
State/province [2] 4556 0
Auckland
Country [3] 4557 0
New Zealand
State/province [3] 4557 0
Waikato

Funding & Sponsors
Funding source category [1] 286001 0
Commercial sector/Industry
Name [1] 286001 0
Douglas Pharmaceuticals Ltd
Address [1] 286001 0
Cnr Te Pai Place and Central Park Drive,
Lincoln,
Auckland 0610
Country [1] 286001 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Douglas Pharmaceuticals Ltd
Address
Cnr Te Pai Place and Central Park Drive,
Lincoln,
Auckland 0610
Country
New Zealand
Secondary sponsor category [1] 284819 0
None
Name [1] 284819 0
Address [1] 284819 0
Country [1] 284819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288048 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 288048 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 288048 0
New Zealand
Date submitted for ethics approval [1] 288048 0
11/10/2012
Approval date [1] 288048 0
16/11/2012
Ethics approval number [1] 288048 0
12/NTA/56

Summary
Brief summary
Acitretin is a synthetic retinoid, structurally related to vitamin A. Its efficacy in psoriasis is well known as an oral treatment for severe psoriasis and disorders of keratinisation. A study of oral acitretin has shown benefit in renal transplant patients with Actinic Keratoses (AKs). AKs, also referred to as solar keratoses, are premalignant intra-epidermal skin lesions that usually arise in photodamaged skin areas. Acitretin is therefore expected to be of benefit in the treatment of AK. Topical acitretin may be associated with few, if any, systemic side effects whilst at the same time producing higher concentrations at the site of treatment compared with oral acitretin. The efficacy and safety of topical acitretin against a placebo control is to be assessed by a phase 2a study, involving approximately 75 participants in New Zealand.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34707 0
A/Prof Marius Rademaker
Address 34707 0
Tristram Clinic
200 Collingwood Street
Hamilton
3204
Country 34707 0
New Zealand
Phone 34707 0
+64 78381035
Fax 34707 0
+64 78382032
Email 34707 0
samantham@douglas.co.nz
Contact person for public queries
Name 17954 0
Mrs Lindsay Boy
Address 17954 0
Douglas Pharmaceuticals Ltd
P.O.Box 45 027,
Te Atatu Peninsula,
Auckland 0651
Country 17954 0
New Zealand
Phone 17954 0
+ 64 98350660
Fax 17954 0
+ 64 98350690
Email 17954 0
lindsayb@douglas.co.nz
Contact person for scientific queries
Name 8882 0
A/Prof Marius Rademaker
Address 8882 0
Tristram Clinic
200 Collingwood Street
Hamilton
3204
Country 8882 0
New Zealand
Phone 8882 0
+64 78381035
Fax 8882 0
+64 78382032
Email 8882 0
rademaker@xtra.co.nz

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