Cutaneous viral warts are very common and are caused by the human papilloma virus (HPV). Most people experience warts in one form or another at some point in their lives. Cutaneous warts are related to different types of HPV. For the palms and soles, HPV 2 has been the most frequently found but HPV 1, 4, 27, and 57 have also been described. Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.
The qHPV and nHPV has been used as a therapeutic approached for the treatment of cutaneous warts in case reports and some case series. Very recently, the Journal of the American Academy of Dermatology (JAAD)-the journal with the highest impact factor in the dermatological field- has published a review of all the cases reported in the scientific literature. The authors were strongly in favor of the use of the vaccine in case of difficult-to-treat warts and have highlighted the need for clinical trials. In the literature, 80 patients have been described with cutaneous warts treated by qHPV or nHPV with more than 50% of efficacy.Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
146
Intramuscular injections of 0,5 ml will be administered at M0, M2 and M6
Hospital Cochin
Paris, France
RECRUITINGComplete remission of cutaneous warts
Complete remission of cutaneous warts 7 months after the first injection of the vaccine
Time frame: 7 months
Quality of Life evaluated
Quality of Life will be evaluated with QoL Questionnaire (DLQI)
Time frame: Inclusion, 2 months, 6 months, 7 months
Pain (VAS)
Pain will be assess using VAS
Time frame: Inclusion, 2 months, 6 months, 7 months
Functional discomfort for walking and functional disability in hands
Functional discomfort for walking and functional disability in hands will be evaluated using the Revised Foot Function index or Cochin hand function scale respectively at M0, M2, M6, M7.
Time frame: Inclusion, 2 months, 6 months, 7 months
Partial remission of cutaneous warts
Partial remission of cutaneous warts 7 months after the first injection of the vaccine.
Time frame: 7 months
Number of warts appeared
Number of warts appeared at M2, M6, M7
Time frame: Inclusion, 2 months, 6 months, 7 months
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