viral wart
Conditions
Interventions
Product Name: Bleomicina
Product Code: 49313
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: BLEOMYCIN
CAS Number: 11056-06-7
Concentration unit: U unit(s)
Concentration type: equal
Conce
Sponsors
Institut d'Investigació Sanitària Pere Virgili (IISPV)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Age ? 18 years. b) Signed informed consent. c) Histological confirmation of wart / s plantar / is viral / s. d) Patients belonging to the area of specialized care of Dermatology Department of Pius Hospital de Valls. e) Failure of previous conventional treatments (cryosurgery, surgery, electrocautery, topical immunomodulators). f) Minimum size of the plantar wart: 0.5 cm. g) Presence of single lesion or multiple lesions equal to or greater than 3 cm distance between them in the foot (both included). h) Ability of patients to follow instructions 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 84 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
Exclusion criteria: a) Background Raynauld phenomenon, peripheral vascular disease or collagen disease known. b) known heart disease c) Previous use of bleomycin d) No informed consent signed or removal thereof e) Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of two parallel treatment groups versus intralesional bleomycin group EQT treatment with intralesional bleomycin for plantar warts, through pre and post treatment (clinical examination and confocal microscopy (RCM)) evaluations to confirm their progression and degree of remission or ultimate demise.;Secondary Objective: 1 Study the TEQ-bleomycin treatment versus control group with intralesional bleomycin treatment for plantar warts using pre and post treatment (clinical examination and MCR) evaluations to confirm their progression and degree of remission or ultimate demise. 2 Assess the degree of safety of the treatment in both groups at 3 months by the presence of potential adverse effects to treatment. 3 Evaluate the effectiveness of treatment in both groups at 3 months by reducing the size of the wart or missing images obtained with confocal microscopy and clinics. 4 Study the treatment group to present less pain compared to plantar warts before and after treatment, using the "EVA" pain scale.;Primary end point(s): Therapeutic improvement in the treatment group 50% of plantar warts virus. Therapeutic improvement in the control group 20% of plantar warts virus.;Timepoint(s) of evaluation of this end point: Therapeutic improvement in the treatment group 50% of plantar warts virus: evaluated using lesion volume confocal microscope. Therapeutic improvement in the control group 20% of plantar warts viral: evaluated using lesion volume confocal microscope. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline evaluations during treatment delivery and outcome of treatment in both groups. In case of adverse events or serious adverse events follow one month after the study ended.;Secondary end point(s): Therapeutic improvement in the control group 20% of plantar warts viral: evaluated using lesion volume confocal microscope. Presence of adverse effects similar to group therapy literature: monitoring of adverse events and serious adverse effects during the study and one month after treatment in both groups. Presence of similar pain in both treatment groups: VAS assessment of pain in both groups, pre and post treatment | — |
Countries
Spain
Contacts
Public ContactCoordinator
Unidad de Estudios Clínicos IISPV
Outcome results
None listed