Condition category
Skin and Connective Tissue Diseases
Date applied
13/02/2015
Date assigned
25/02/2015
Last edited
15/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Dr Rosemarie Sift Carter

ORCID ID

Contact details

Hauptstrasse 67
Binningen
4102
Switzerland

Additional identifiers

EudraCT 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

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

Trial setting

Other

Trial 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

Phase

Phase II

Drug names

Artemether

Primary outcome measures

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 trial start date

02/02/2015

Overall trial end date

31/07/2015

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/06/2016: The timepoints of measurement for the primary and secondary outcome measures as well as the publication and dissemination plan have been added. In addition, the interventions section has been updated. 24/03/2016: Ethics approval information added.