Cutaneous wart lesions on hands and/or feet at immune suppressed, kidney transplanted patients. MedDRA version: 9.1 Level: LLT Classification code 10010115 Term: Common warts
Conditions
Interventions
Product Name: Bovine a-lactalbumin complex with oleic acid(bLAC)
Product Code: bLAC
Pharmaceutical Form: Gel
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Cutaneous u
Sponsors
NatImmune A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with cutaneous warts located on fingers and/or palms and/or toes and/or soles of the feet. 2. Index Wart lesions include: common warts (verruca vulgaris) and mosaic warts. Index warts lesions must be diagnosed by an experienced dermatologist on clinical basis. 3. Patients with a solitary wart lesion with a diameter of at least 1 cm2, or patients with 2 or more wart lesions, the minimum area of each of the selected index wart lesions is 0.5 cm². (A maximum of eight lesions is selected for treatment and the maximum of total index lesion area = 9 cm²). 4. Index wart lesions should have been present for more than 6 months. 5. Men or women, aged 18 or above. 6. All patients should have a history of a kidney transplantation and immune suppressive therapy after the transplant. 7. Concomitant immune suppressive therapy should have been stable for 6 monthsprior to randomisation, defined as no changes in number of drugs used, but a change in doses for the individual immune suppressive drugs of ± 50 % is allowed in the 6 months prior to randomisation 8. Agreement from the patient to allow photographs of the selected warts to be taken and used as part of the trial data documentation (2 centres). 9. Women of childbearing potential must have a negative pregnancy test at screening and must use adequate contraception (pill, contraceptive implant, intrauterine device) during the trial. 10. Ability to comply with the requirements of the trial. 11. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Verruca plana lesions. 2. Patients suspected of allergy to milk verified by serum analysis of IgG towards cow milk. 3. Breastfeeding patients. 4. Any local medications for any purpose other than wart treatment in the target area during 4 weeks prior to randomisation and during the treatment period (weeks 0-8). 5. Concomitant treatment with other wart therapies two weeks prior to randomisation in the present trial and during the clinical trial period. 6. Intolerance towards bovine a-lactalbumin, oleic acid, or any excipient in the bLAC formulation. 7. Known HIV infection or any current uncontrolled infection. 8. Any chronic or acute skin condition susceptible of interfering with the evaluation of the drug effect in this trial. 9. Participation in any investigational trial or use of any investigational drug within 30 days prior to inclusion in this trial. 10. Any health problems, which according to the Investigator’s clinical judgment will make the patient unsuitable for inclusion in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The clinical proof of concept of bLAC is to demonstrate a reduction in the area of the wart lesions located on fingers and/or palms and/or toes and/or soles of the feet, (measured by an objective method by drawings of the individual lesions) at two dose levels of bLAC, compared with placebo The lowest dose of bLAC that will be efficacious in treatment of warts will be recommended for further studies. ;Secondary Objective: The secondary efficacy objectives are to investigate the efficacy of bLAC in comparison with placebo • to clear index warts • on time to clear index warts • on changes in area of total index lesion size over time • to prevent recurrence of previously cleared index warts • to prevent new wart lesions to occur • to assess overall changes in index wart lesions • to assess the overall status of other wart lesions on hands and feet (index wart lesions excluded) and impact of treatment ;Primary end point(s): Percent change from baseline to end-of 8 weeks treatment in the pre-selected wart lesion size, determined as area of lesion. The area of each index lesion will be calculated based on drawing and area will be determined by scanning of the drawing. The primary endpoint will be summarized by mean percent change, classified by treatment and visit for each centre. The statistical model for the rate of reduction at week 1, 4 and 8 will be a mixed model ANOVA. The null hypothesis to be tested is that there is no difference in treatment effects at visit four (week 8). | — |
Countries
Denmark, Sweden
Outcome results
None listed