A study to determine the efficacy of a topically applied artemether gel in the treatment of senile warts.

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN12424904
• Date of registration: 25/02/2015
• Prospective Registration: No
• Primary sponsor: EpiPharm AG
• Public title: A study to determine the efficacy of a topically applied artemether gel in the treatment of senile warts.
• 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
• Date of first enrolment: 20/02/2015
• Target sample size: 15
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN12424904
• Study type: Interventional
• Study design: Open-label intra-individual comparison proof-of-concept study (Treatment)
• Phase: Phase II

Countries of recruitment

Switzerland

Contacts

• Name: Rosemarie Sift Carter

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Seborrheic keratosis
Skin and Connective Tissue Diseases
Seborrheic keratosis

Intervention(s)

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

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

EPI-02

Source(s) of Monetary Support

EpiPharm AG