Plain English Summary
Background and study aims
Senile warts are benign skin tumours. They are removed by invasive, unpleasant methods (curettage, cryotherapy, laser, surgery) with certain risks (e.g. infection, depigmentation). This clinical proof of concept study aims to assess the efficacy of an artemether topical formulation in the treatment of senile warts.
Who can participate?
Each participant must have at least 8 flat or slightly elevated senile warts.
What does the study involve?
The test product will be applied twice daily for up to 8 weeks. Five lesions per study participant will be treated with study medication and 3 will serve as reference lesions. The assessment of efficacy will be performed on the photographs taken at the beginning and the treatment and study end by applying a regression score and by measuring the longest axis of lesion.
What are the possible benefits and risks of participating?
The potential benefit for participants is a painless, non-invasive treatment leading to regression or clearance of seborrheic keratosis. Development of adverse events like pruritis, erythema are possible risks associated with the treatment.
Where is the study run from?
The study will be carried out in a dermatology clinic.
When is the study starting and how long is it expected to run for?
From February 2015 to July 2015.
Who is funding the study?
EpiPharm AG
Who is the main contact?
Dr Rosemarie Sift Carter
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
EPI-02
Study information
Scientific title
Single centre, open-label, intra-individual, comparison, proof of concept study to determine the efficacy of an artemether topical formulation in subjects with seborrheic keratosis
Acronym
Study hypothesis
Treatment of seborrheic keratosis with artemether will lead to regression of the lesions compared to no treatment.
Ethics approval(s)
Ethic Committee of North-Western and Central Switzerland, 17/01/2015, reference number: EKNZ 2014-390
Study design
Open-label intra-individual comparison proof-of-concept study
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Condition
Seborrheic keratosis
Intervention
Interventions as of 15/06/2016:
A total of 8 lesions per subject are identified at visit 1 (day 1), 5 of them are allocated to artemether treatment and 3 serve as reference lesions. Artemether 3% is to be administered for a duration of 8 weeks twice daily (i.e. in the morning and evening). The study lesions will be assessed at baseline visit (day 1) and at treatment end and follow-up/study end visits (day 56 and day 85) based on the clinical appearance and the dermoscopic images taken. In addition, the lengths of lesions will be measured at the corresponding visits.
Original interventions:
Topical artemether formulation
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
Artemether
Primary outcome measure
1. Regression of lesions by assessing the lesions with a 6-point IGA (Investigator Global Assessment) Score at baseline, 56 and 85 days
2. Reduction of lesion size by measuring the longest axis (mm) of the lesion at baseline visit (V1) and at baseline, 56 and 85 days
Secondary outcome measures
therapy outcome, i.e. the IGA (investigator global assessment) score and lengths of treated lesions versus reference (not treated) lesions at 56 and 85 days.
Overall study start date
02/02/2015
Overall study end date
31/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age above 40 years old
2. Phototype II, III and IV
3. At least 8 flat or slightly elevated SK lesions with a “pasted-on” look and typical
characteristics
4. Lesion size: longest axis (dimension) 2 mm to 10mm
5. Willingness to participate in the study and to comply with the study protocol
6. Written informed consent
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
15
Participant exclusion criteria
1. Presence of pregnancy, lactation, childbearing potential without contraception
2. Female participants of childbearing potential not using and not willing to continue using a medically reliable method of contraception
4. SK lesion close to the eye or mucosa (mouth, genitals)
5. Lesion in a skin fold or an area where clothing (e.g. belt) may cause physical irritation
6. Pedunculated, verrucous, papilomatous and irritated lesions
7. Presence of clinically significant skin or systemic disease
8. Pathological findings at screening (melanoma, lentigo maligna, inflammation, bleeding)
9. Concomitant participation in another study
10. Traveling to regions with endemic malaria
11. Previous use of treatment of the lesions within 2 years prior to visit 1
12. Known or suspected non-compliance, drug or alcohol abuse
13. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
14. Enrolment of the investigator, his/her family members, employees and other dependent persons
Recruitment start date
20/02/2015
Recruitment end date
30/03/2015
Locations
Countries of recruitment
Switzerland
Study participating centre
Somamedica AG
Zollikerstrasse 106
Zollikon
8702
Switzerland
Sponsor information
Organisation
EpiPharm AG
Sponsor details
Hauptstrasse 67
Binningen
4102
Switzerland
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
EpiPharm AG
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication planned in a peer reviewed journal .
Intention to publish date
30/06/2017
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|