Verruca vulgaris and verruca plantaris Infections and Infestations Viral warts
Conditions
Interventions
Investigational device: Excilor® 2 in 1 wart treatment
Name/code: Cryo-ActiveTM - Contact freezing
Galenic form: TCA-ActiveTM (based on Trichloroacetic Acid) – Gel
a maximum of three treatment cycles
Administration route: Topical
Sponsors
Medical Brands
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Poland
Outcome results
None listed