ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000025235

Ethics application status

Approved

Date submitted

25/11/2008

Date registered

15/01/2009

Date last updated

4/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Photodynamic therapy for prevention of skin cancers

Scientific title

Randomized controlled clinical trial of photodynamic therapy treatment for the prevention of skin cancers on the face for patients with a history of a skin cancer on the face

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Premalignant field cancerization on the face

Condition category

Condition code

Skin

Dermatological conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Aminolevulonic acid (ALA) photodynamic therapy. Two treatments two weeks apart per patient in in the intervention arm of trial. Patients will have stabilised 5% ALA massaged on to their face skin. They will then have a 5 hour incubation before illumination under blue light for 20 minutes and red light for 10 minutes.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control with no intervention Controls recieve standard treatment of observation, follow up and biopsy of any suspicious lesions. Reviews will be 6 monthly for two years. At reviews a skin check will be undertaken with any suspicious face lesion biopsied. and skin cancers on the face will be excised.

Control group

Active

Outcomes

Primary outcome [1]

To determine whether field treatment of actinic keratoses with photodynamic therapy results in fewer subsequent invasive skin cancers developing on the face in patients who have previously suffered a skin cancer on the face. Development of skin cancers will be assessed by biopsy of any suspicious lesion and surgical excision of any proven skin cancer.

Timepoint [1]

Baseline then 6 monthly for 2 years

Secondary outcome [1]

To determine whether photodynamic therapy produces an improved cosmetic outcome and a sustained clearance rate of actinic keratoses on the face than observation. This outcome will be assessed by baseline photographs to be used for later comparision by doctor and patient.

Timepoint [1]

An assessment is not made at baseline but rather a photograph of face (full frontal) is taken at baseline. Assessment is then made each 6 months for 2 years with comparison to baseline photograph on each occasion.

Eligibility

Key inclusion criteria

Patients who have suffered 1 or more skin cancers on the face

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients under 18 years of age
Patients unwilling to enrol
Patients unwilling to be randomized
Patients not understanding the trial protocol and process including patients with dementia
Patients with untreated skin cancers on the face. (All cancers on the face would need to be surgically excised with histologic confirmation prior to enrolment)
Patients that have already been treated with PDT to their face

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomization will be completed off site to any treatment / intervention centre. Signed consent to participation in the trial will be retained by each treatment centre. Patients will be enrolled electronically at each treatment centre. An on line form will be completed and submitted with each enrolment.
The randomization site will implement randomization each 3 or 4 days for electronic enrolments in that time.
Randomization will take a single step. Patients will be randomized into intervention versus observation arms. This will be effected by a barrel containing 50 discs, 25 of one colour and 25 of an alternate colour. Once 50 patients have enrolled in the study, all discs will be returned for the next 50 enrolments. This process will continue until 500 patients have been enrolled.
The randomization centre will then complete an electronic form that will be downloaded to the intervention centre advising the centre whether the patient is randomised to intervention or not.
The trial will not be blinded. Patients and attending medical staff will be aware of whether or not a patient has been randomized to intervention.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

This will be effected by a barrel containing 50 discs, 25 of one colour and 25 of an alternate colour. Once 50 patients have enrolled in the study, all discs will be returned for the next 50 enrolments. This process will continue until 500 patients have been enrolled.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/01/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3216

Recruitment postcode(s) [2]

4215

Recruitment postcode(s) [3]

7531

Recruitment postcode(s) [4]

3860

Recruitment postcode(s) [5]

2337

Recruitment postcode(s) [6]

4812

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Allmedic

Address [1]

Unit 2/4 Endeavour Road Taren Point NSW 2229

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Allmedic

Address

Unit 2/4 Endeavour Road Taren Point NSW 2229

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr. William Anseline

Address [1]

Skin Alert Paradise Point,
20 Falkinder Ave, Paradise Point, Queensland, 4216

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr. Peter Smith

Address [2]

77 highcrest Circuit, Ashmore, , Queensland, 4214

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr. Helena Rosengren

Address [3]

149 Charters Towers Rd, Townsville, Queensland, 4810

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Dr. John Dixon

Address [4]

3702 Eureka tower,
7 Riverside Quay, Southbank, Victoria, 3006

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Dr. Richard Abbott

Address [5]

Scone Medical,
5 Surman St,
Scone, NSW, 2337

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Dr. Stuart Anderson

Address [6]

3 Landy St, Maffra, Victoria, 3860

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bond University Human Research Ethics committee

Ethics committee address [1]

University Drive, Robina, Gold coast, Queensland

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/10/2008

Approval date [1]

19/11/2008

Ethics approval number [1]

RO 857

Summary

Brief summary

A prospective multicentre multinational randomized controlled trial is planned.
The control group will be managed by observation, review with surgical management of future skin cancers if and when they occur. The observation group reflects current common practice. That is, current practice is that patients who have had skin cancers are followed through indefinitely to observe for new skin cancers to be then treated once they are diagnosed. 
The intervention group will have pre-treatment with AHA followed by PDT. 
Intervention centres:	
This trial will take place at 6 centres managing patients with skin cancer and actinic keratoses. There will be 6 centres in Australia, Victoria X 2, Western Australia, New South Wales and Queensland X 2 sites. These sites provide a combination of northern, central and southern latitudes as well as eastern and western longitudes. There will also be a northern hemisphere centre based in Missouri USA.
Each treatment centre will be provided with the required products and illumination light. 
Intervention arm:
Patients randomized to the intervention arm will be supplied with “Face Repair” (Allmedic ® 10% alpha hydroxy acid solution) to use twice daily for 14 days prior to the initial PDT treatment. They will also be provided with a SPF 30 antioxidant sunscreen (Allmedic ®) for usage twice daily in the lead up to PDT.
Two PDT treatments will be effected 10 to 14 days apart. The patient will be incubated with Allmedic ® 20% ALA to each side of the face. Incubation will involve the liquid being massaged into each side of face to provide a thin and uniform cover. Incubation will be effected by the doctor or practice nurse. All such medical staff will be trained in advance regarding this technique. A firm massage of the liquid into the face will be effected.
No product will be applied close to eye lashes or pink lip. Otherwise all skin areas from the hairline to the lower border of the mandible and from anterior border of the ear to the opposite anterior border of the ear will be included.
There will be 5 hours planned between incubation and illumination. During this period, the patient will be advised to wear a broad brimmed hat and to avoid sunlight or bright lights. The patient will be encouraged to remain indoors whenever possible between incubation and illumination.
Prior to illumination, the face will be washed with warm water and dried. 
During illumination, the eyes of the patient will be shielded from the light source. Each patient will have an attendant(s) at all times during illumination. A fan to reduce heat of treatment will be provided as required. The attendant(s) will wear dark sun glasses during illumination. 
Illumination will involve the Allmedic ® Tru+PDT light source, applied with the blue light for 20 minutes and then the red light for 10 minutes. No ultraviolet light will be used in the illumination phase.
Following treatment, the patient will be advised to continue to wear the broad brimmed hat indoors and outdoors for five days and to continue to avoid bright lights. Advice re analgesia and moisturising cream will be provided. 
A second PDT treatment 10 to 14 days later will follow the same process.
Observation arm:
No immediate treatment or intervention will be provided for their background sun damaged skin. They will be followed up as detailed below.
All patients, (including observation patients) will be given general advice regarding sun protection including sunscreens when outdoors. It is recognised that even sunscreens can have an effect on reducing actinic keratoses.31, 32
Follow up:
All patients will have scheduled appointments each six months for two years following randomization. Patients will be further invited to attend for appointments in addition to scheduled appointments if they consider problems have arisen or occurring requiring such attention.
At follow up, any face lesion suspicious of skin malignancy will be punch biopsied or locally excised. The punch biopsy will be a minimum of 4 mm in diameter. Where histology demonstrates actinic damage but no skin cancer (as previously defined), the lesion will be observed. Where the histology indicates skin cancer, treatment will be by surgical excision. This may involve Mohs’ surgery if considered appropriate. New face skin cancers occurring during the follow up two year period will not be treated with imiquimod, 5FU, curettage, ablation, etc,.
At each follow up appointment, a further on line progress form will be downloaded to the central study database. The doctor and patient will both compare their face at each appointment to the baseline enrolment photograph.
If a lesion is biopsied and / or excised on the face in that two year period, a further form will be completed on line and downloaded detailing such an event.
Photography:
Each enrolled patient will be photographed prior to any intervention. The digital photograph will be taken with the camera at least 1.5 metres from the patient. A minimum 6 Megapixel digital camera image will be taken and stored. The photograph will involve only the face from the neck up. The subject will be facing directly towards and looking at the camera. Controlled lighting and conditions will apply. At 6 months post randomization and at completion of follow up, photographs of the same methodology will be taken. Photographs will be used to assist patients and clinicians detecting an appearance alteration during the trial period.

Trial website

http://skincanceronly.com.au/Home/For_doctors.aspx

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Anthony Dixon

Address

66 Roslyn Rd.
Belmont, Victoria, 3216

Country

Australia

Phone

+61 3 5244 5100

Fax

+61 3 5243 4323

admin@skincanceronly.com

Contact person for scientific queries

Name

Dr. Anthony Dixon

Address

66 Roslyn Rd.
Belmont, Victoria, 3216

Country

Australia

Phone

+61 3 5244 5100

Fax

admin@skincanceronly.com

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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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