Clinical evaluation of the safety and effectiveness of Excilor 2-in-1 Wart Treatment in the treatment of warts on the hands and feet
| ISRCTN | ISRCTN39469406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39469406 |
| Secondary identifying numbers | 18E3526 |
- Submission date
- 20/07/2022
- Registration date
- 27/07/2022
- Last edited
- 27/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
Both cryotherapy (freezing) and gel treatment are proven effective and safe treatments for wart removal. They are the most commonly used treatments currently on the market and have both been studied extensively for their effectiveness and safety. Combining these treatments could achieve higher cure rates and reduce the number of applications required. The aim of this study is to evaluate the effectiveness and safety of the Excilor® 2 in 1 wart treatment in the treatment of hand and foot warts.
Who can participate?
Adults and children (ages 4- 65 years) with warts on their hands and/or feet
What does the study involve?
Excilor® 2 in 1 wart treatment is applied topically during a treatment cycle of 5 days (one to three treatment cycles, depending on the wart state, with a resting period of 14 days between the treatment cycles).
What are the possible benefits and risks of participating?
Cryotherapy treatment as well as TCA wart treatment are both treatments that are used in practice by general practitioners and individuals. The risks of each treatment are known and classified as minor.
Where is the study run from?
Medical Brands (Netherlands)
When is the study starting and how long is it expected to run for?
October 2018 to September 2019
Who is funding the study?
Medical Brands (Netherlands)
Who is the main contact?
Erica Brusà, Clinical@medicalbrands.com
Contact information
Ms Erica Brusà
Scientific
Scientific
Piet Heinkade
Amsterdam
1019HC
Netherlands
| Phone | +31 (0)20 345 5330 |
|---|---|
| Clinical@medicalbrands.com |
Study information
| Study design | Open non-randomized before/after comparison single-centre clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Clinical evaluation of the efficacy and safety of Excilor 2-in-1 Wart Treatment in the treatment of verruca vulgaris and verruca plantaris |
| Study hypothesis | The primary objective of this study was to evaluate the efficacy of Excilor® 2 in 1 wart treatment in the treatment of verruca vulgaris and verruca plantaris. The secondary objective of this study is to evaluate the safety of Excilor® 2 in 1 wart treatment by recording the occurrence of adverse reactions. |
| Ethics approval(s) | Approved 04/12/2018, Bioethics Committee of the Regional Chamber of Physicians in Gdansk (Sniadeckich 33, 80-204 Gdansk, Poland; +48 (0)58 524 32 50; bioetyka@komisjabioetyczna.pl), ref: KB – 772 / 2018 / 04.12.2018, Protocol number #18E3526 |
| Condition | Verruca vulgaris and verruca plantaris |
| Intervention | Investigational device: Excilor® 2 in 1 wart treatment Name/code: Cryo-ActiveTM - Contact freezing Galenic form: TCA-ActiveTM (based on Trichloroacetic Acid) – Gel Duration 5 days per treatment cycle; a maximum of three treatment cycles Administration route: Topical |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Excilor® 2 in 1 wart treatment |
| Primary outcome measure | 1. Clinical scores used to assess average wart size, swelling and softness of the wart are taken at baseline, day 19 (visit 2), day 32 or 38 (visit 3), day 51 or f7 (visit 4) and day 70 (visit 5): 1.1. Wart size measured on a scale of 0-10, 0 = absent, 10= very large 1.2. Swelling measured on a scale of 0-10, 0 = no swelling, 10= swollen wart 1.3. Wart softness measured on a scale of 0-10, 0 = soft skin on the wart, 10 = stiff skin on the wart 2. Diameter of wart measured using a calliper at baseline, day 19 (visit 2), day 32* or 38 (visit 3), day 51* or 57 (visit 4) and day 70* (visit 5) 3. Change in the wart after the treatment assessed using macrophotographs taken with a Nikon D90 at baseline, day 19 (visit 2), day 32* or 38 (visit 3), day 51* or 57 (visit 4) and day 70* (visit 5) 4. Impact of the wart on quality of life assessed using a Quality of Life Questionnaire (QOL) is completed at baseline, day 32* or 38 (visit 3), day 51* or 57 (visit 4) and day 70* (visit 5) 5. Properties, efficacy, tolerance and future use of the studied product assessed using a subjective evaluation questionnaire filled in by the subject at day 32/38 (visit 3), day 51/57 (visit 4) and day 70 (visit 5) *D32 is applicable for subjects needing 1 treatment cycle; D38 is applicable for subjects needing at least 2 treatment cycles **D51 is applicable for subjects needing 2 treatment cycles; D57 is applicable for subjects needing 3 treatment cycles ***D70 is applicable for subjects needing 3 treatment cycles |
| Secondary outcome measures | Adverse events collected throughout the study course and recorded by the subjects every day in the daily log and by the investigator in the CRF at every visit |
| Overall study start date | 01/10/2018 |
| Overall study end date | 06/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 4 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 66 |
| Participant inclusion criteria | 1. Sex: female and/or male 2. Age: 45 adults 18-65 years old (inclusive) and 15 children 4-17 years old (inclusive) 3. Subjects with at least one selected wart on the hand or foot not older than 1 year and not previously treated and having a diameter of 2 to 5 mm 4. Subjects or parents/legal guardians psychologically able to understand the study-related information and to give a written informed consent 5. Subjects or parents/legal guardians have given freely and expressly their informed consent 6. Subjects or parents/legal guardians able to comply with protocol requirements, as defined in the protocol 7. Females of childbearing potential should use a medically accepted contraceptive regimen from at least 12 weeks before the beginning of the study till at least 1 month after study completion |
| Participant exclusion criteria | Population: 1. Pregnant or nursing subject or planning a pregnancy during the study (females only) 2. Subject who had been deprived of her/his freedom by administrative or legal decision or who is under guardianship 3. A subject in a social or sanitary establishment 4. A subject in an emergency situation 5. A subject suspected to be non-compliant according to the investigator’s judgement Associated pathology: 1. A subject having clinically significant dermatological pathologies on the tested area, according to the investigator’s judgment 2. A subject suffering from a clinically significant illness, stabilized or evolutionary, according to the investigator’s judgement 3. Subjects who are suffering from diabetic and/or have a poor blood circulation 4. Subjects presenting skin tags, moles, dark patches of skin, freckles, water warts (mollusca contagiosa), seborrhoeic keratosis (verruca seborrhoica) or exfoliated skin in the to be tested skin area 5. Damaged, open and/or inflamed skin in the treated area 6. Subjects with a known allergy or sensitivity to one of the products’ components 7. Immunosuppressed subjects Previous or ongoing treatment: 1. Any treatment which, in the investigator’s judgement, put the patient at undue risk or may interfere with the evaluation of the study results Lifestyle: 1. Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during or within 4-6 weeks after the study 2. A patient planning to change her/his life habits during the study (diet, cosmetic products use, sport activity etc) |
| Recruitment start date | 01/12/2018 |
| Recruitment end date | 14/06/2019 |
Locations
Countries of recruitment
- Poland
Study participating centre
Dermscan Poland
ul. Kruczkowskiego 12 80-288
Gdansk
80-288
Poland
Gdansk
80-288
Poland
Sponsor information
Medical Brands
Industry
Industry
Piet Heinkade
Amsterdam
1019HC
Netherlands
| Phone | +31 (0)20 345 5330 |
|---|---|
| Clinical@medicalbrands.com |
Funders
Funder type
Industry
Medical Brands
No information available
Results and Publications
| Intention to publish date | 31/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results summary to be published/made available on ISRCTN 07/2021. |
| IPD sharing plan | In accordance with Good Clinical Practices (GCP) and the standards of the data protection law, data obtained during research involving human beings must be treated confidentially to guarantee the patients’ privacy. Conforming with local regulations and ethical considerations, the sponsor representatives and/or any regulatory agency have direct access to all study records, CRFs, corresponding subject/patient medical records and any other documents considered source documentation. This data will not be made publicly available. Dermscan (CRO) must archive the CIP, documentation, approvals and all other essential documents related to the study. At the end of this period (15 years), the study archives will be destroyed unless otherwise stipulated in writing by the sponsor/only when stipulated in writing by the sponsor (Medical Brands). |
Editorial Notes
22/07/2022: Trial's existence confirmed by the Bioethics Committee of the Regional Chamber of Physicians in Gdansk.
