Actively Recruiting
Study to Evaluate the Efficacy of 2LVERU4 JUNIOR and 2LVERU4 on the Treatment of Warts
Led by Labo'Life · Updated on 2024-10-30
162
Participants Needed
18
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Human papillomavirus (HPV) infection is very common and often causes warts, which can appear at any age. This research investigates the effectiveness of two treatments, 2LVERU4 JUNIOR and 2LVERU4, compared to a placebo, in helping warts disappear. The study is placebo-controlled, randomized, and double-blind, aiming to see if these treatments improve wart clearance by the end of six months of treatment. Participants will take one capsule daily for six months, either 2LVERU4 JUNIOR or 2LVERU4, or a placebo, all taken on an empty stomach before breakfast. After the treatment phase, there is a three-month follow-up to monitor for any wart recurrence. Success is measured by normal skin color, texture, and touch at wart sites compared to the start of the study. During the study, participants will have regular assessments up to nine months from the start, including checking wart disappearance at four and six months and tracking any recurrence three months after treatment ends. Pain related to warts and safety through adverse event monitoring will also be evaluated. The study expects to enroll 162 patients aged three years and older with common, plantar, or flat warts.
CONDITIONS
Brief Title
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 3 years and older
- Patients with common warts (Verruca vulgaris), plantar warts (Verruca plantaris), and/or flat warts (Verruca plana)
- Patients (or parents if needed) able to understand and follow study requirements
- Signed informed consent by patient or parent if necessary
You will not qualify if you...
- Received curative wart treatment or homeopathic treatment in the past 2 months
- Currently under immunosuppressive treatment
- Received immunotherapy or micro-immunotherapy in the last 6 months
- Known lactose intolerance
- Pregnant or breastfeeding women
- Participated in another clinical study in the past 2 months
- Not motivated to complete the study or likely to move before study end
- Severe immunodeficiency requiring long-term treatment, chemotherapy, or radiotherapy
- Taking certain homeopathic or phytotherapy treatments
- Addicted to or using recreational drugs
- Under guardianship or curatorship
- Important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take one capsule daily for 6 months to treat warts.
Visits at 4 months and 6 months for treatment evaluation
Duration - 3 months
Participants are monitored for 3 months after treatment to assess wart recurrence and safety.
1 visit at 9 months
Trial Site Locations
Total: 18 locations
1
Private Practice
Arlon, Belgium, 6700
Withdrawn
2
Clinique Saint-Luc (Bouge)
Bouge, Belgium, 5004
Actively Recruiting
3
Private Practice
Brussels, Belgium, 1020
Terminated
4
Private Practice
Écaussinnes-d'Enghien, Belgium, 7190
Terminated
5
Private Practice
Fontaine l'Êveque, Belgium, 6140
Suspended
6
Private Practice
Ghent, Belgium, 9942
Actively Recruiting
7
Private Practice
Gozée, Belgium, 6534
Terminated
8
Private Practice
Hamme-Mille, Belgium, 1320
Actively Recruiting
9
Private Practice
Juprelle, Belgium, 4450
Withdrawn
10
Private Practice
Mons, Belgium, 7000
Withdrawn
11
Private Practice
Namur, Belgium, 5000
Actively Recruiting
12
Private Practice
Namur, Belgium, 5000
Withdrawn
13
Private Practice
Oisquercq, Belgium, 1480
Terminated
14
Private Practice
Plancenoit, Belgium, 1380
Withdrawn
15
Private Practice
Quiévrain, Belgium, 7380
Withdrawn
16
Private Practice
Saint-Symphorien, Belgium, 7030
Actively Recruiting
17
Private Practice
Seneffe, Belgium, 7180
Actively Recruiting
18
Private Practice
Wavre, Belgium, 1300
Actively Recruiting
Research Team
C
Charlotte Bolle
L
Laura FERTE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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