A study to determine the efficacy of a topically applied artemether gel in the treatment of senile warts.
| ISRCTN | ISRCTN12424904 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12424904 |
| Secondary identifying numbers | EPI-02 |
- Submission date
- 13/02/2015
- Registration date
- 25/02/2015
- Last edited
- 15/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Public
Hauptstrasse 67
Binningen
4102
Switzerland
Study information
| 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 |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/02/2015 |
| Date of final enrolment | 30/03/2015 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Zollikon
8702
Switzerland
Sponsor information
Industry
Hauptstrasse 67
Binningen
4102
Switzerland
"ROR" |
https://ror.org/040fx6j66 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication planned in a peer reviewed journal . |
| IPD sharing plan |
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.
