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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Topical immunotherapy with diphencyprone for cutaneous metastatic melanoma
Scientific title
Response of cutaneous metastatic melanoma to topical immunotherapy with diphencyprone
Secondary ID [1] 283663 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma metastatic and/or locally recurrent to skin 236933 0
Condition category
Condition code
Cancer 237292 237292 0 0
Malignant melanoma

Study type
Description of intervention(s) / exposure
Topical application of diphencyprone cream to cutaneous metastases.

The optimal diphencyprone dose is determined in each patient as the concentration causing adequate but not excessive contact dermatitis. The concentration may range from 0.0001% to 2%, mixed in aqueous cream. The cream is applied once per week, for 24 to 48 hours depending on intensity of response.

If there has been no response in 3 months, the treatment will be ceased. If there is response, the treatment can be continued indefinitely until refractory disease recurrence/progression. Usually, patients will require ~1 to 3 months to achieve a response. Ongoing treatment (ie, cream applied each week at home by patients) will then be offered to any patients who request it, with the aim of preventing further recurrence.
Intervention code [1] 236723 0
Treatment: Drugs
Intervention code [2] 236757 0
Treatment: Other
Comparator / control treatment
Control group

Primary outcome [1] 238103 0
Clinical clearance of cutaneous metastases (ie, active cutaneous lesions are no longer visible or palpable)
Timepoint [1] 238103 0
1, 3, 6, 12 and 24 months following development of contact hypersensitivity response to diphencyprone
Secondary outcome [1] 242311 0
Histological clearance of cutaneous metastases (S100 stain after melanin bleaching on biopsy taken from treated area)
Timepoint [1] 242311 0
1, 3, 6, 12 and 24 months following development of contact hypersensitivity response to diphencyprone

Key inclusion criteria
Melanoma locally recurrent or metastatic to skin
Minimum age
No limit
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Pregnancy or lactation
Severe uncontrolled eczema
Previous type I hypersensitivity to diphencyprone
Primary melanoma

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No treatment allocation: uncontrolled study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 1 / Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237119 0
Name [1] 237119 0
Royal Prince Alfred Hospital
Address [1] 237119 0
Missenden Rd
Camperdown NSW 2050
Country [1] 237119 0
Primary sponsor type
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Secondary sponsor category [1] 4612 0
Name [1] 4612 0
Address [1] 4612 0
Country [1] 4612 0
Other collaborator category [1] 705 0
Other Collaborative groups
Name [1] 705 0
Sydney Melanoma Unit
Address [1] 705 0
GH3, Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country [1] 705 0

Ethics approval
Ethics application status
Ethics committee name [1] 239216 0
Sydney South West Area Health Service Ethics Committee
Ethics committee address [1] 239216 0
Level 3 Building 92
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Ethics committee country [1] 239216 0
Date submitted for ethics approval [1] 239216 0
Approval date [1] 239216 0
Ethics approval number [1] 239216 0

Brief summary
The objective is to investigate whether diphencyprone (DPCP), a chemical which can cause contact allergy on the skin in about 95% of people, can stimulate the immune system to destroy these melanoma cells. DPCP is frequently used in dermatology as a treatment for autoimmune hair loss (alopecia areata) and warts, where it also stimulates an immune attack on the wart virus. As melanoma is a tumour which is known to be particularly susceptible to immune attack, it is hoped that DPCP treatment will be helpful to patients with otherwise untreatable secondary melanoma in their skin. There have so far been a handful of published case reports of patients in whom DPCP has been helpful for melanoma.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 29712 0
Prof Diona Damian
Address 29712 0
Dermatology, GH3
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 29712 0
Phone 29712 0
+612 9515 8295
Fax 29712 0
Email 29712 0
Contact person for public queries
Name 12959 0
Prof Diona Damian
Address 12959 0
Dermatology, GH3
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 12959 0
Phone 12959 0
612 9515 8295
Fax 12959 0
612 9565 1048
Email 12959 0
Contact person for scientific queries
Name 3887 0
Prof Diona Damian
Address 3887 0
Dermatology, GH3
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 3887 0
Phone 3887 0
612 9515 8295
Fax 3887 0
612 9565 1048
Email 3887 0

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