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Isotretinoin

One capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks.

One capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks.

One capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks.

Isotretinoin capsules

María Guadalupe Olguín-García, M.D., MSc.

Martha Alejandra Morales-Sánchez, M.D., MSc.

María Guadalupe Olguín-García, M.D.,MSc.

Randomized clinical trial to compare the efficacy of different doses of oral isotretinoin 10 mg/day, 20 mg/day and 30 mg/day during 12 weeks for the treatment of facial recalcitrant flat warts. The primary endpoint will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.

The investigators will recruit 162 participants with facial recalcitrant flat warts and randomize to the following three arms of intervention: Arm 1: nne capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks; Arm 2: one capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks; and Arm 3: one capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. The primary endpoints will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial; and the incidence of side effects related to oral isotretinoin treatment among the 3 arms of treatment.

All the interventions will be similar in appearance and all the participants will take the same quantity of capsules.

Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts

Efficacy and Safety of Oral Isotretinoin 10 mg, 20 mg and 30 mg for the Treatment of Facial Recalcitrant Flat Warts at Centro Dermatológico "Dr. Ladislao de la Pascua": Randomized Double-blinded Clinical Trial of Three Arms

Proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.

Proportion of participants that developed a serious side effect in the three arms during the clinical trial.

Difference in the Dermatology Life Quality Index score at the end of the study, comparing with the basal score. The minimum score is 0 points and the maximum 30 points. A score higher than 10 points means that the patient's life is severely affected by melasma.

Percentage of taken-doses of oral isotretinoin during the 12 weeks of the study.

Centro Dermatológico Dr. Ladislao de la Pascua

Group N°1: 2LVERU® or 2LVERU® JUNIOR treatment (6 months of treatment)

Group N°2: Placebo treatment (6 months of treatment)

The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment.

The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

2LVERU® or 2LVERU® JUNIOR

Placebo

Charlotte Bolle

Laura FERTE

Audrey SCHILS, Dr

Filip Dr Verrue

Susanne Dr Hausdorfer

Bernadette BLOUARD, Dr

Nathalie BEAUCHOT, Dr

Kristel MESTDAGH, Dr

Wolfram FINK, Dr

Wolfram Fink, Dr

Human papillomavirus (HPV) infection is very common, as most people will experience infection during their lifetime. The most common manifestation of HPV infection is common warts. Common warts may appear at any age.

Conventional treatments can be used to treat warts and they are based on two mechanisms: stimulation of cellular immunity against HPVs or destruction of the lesion. These treatments are based on the location of the wart and the degree of the symptoms.

No specific antiviral therapy is available to cure warts and today, there is no treatment that allows the definitive eradication of the virus.

The 2LVERU® has been available for more than 20 years, and has received a marketing authorization in Belgium by the Federal Agency for Medicines and Health Products (FAMHP). It is used as an immune regulator in the treatment of common warts (verruca vulgaris), flat warts (verruca plana) or plantar warts (verruca plantaris) caused by Human Papillomavirus. Since 2LVERU® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the disappearance of warts.

The purpose of this placebo-controlled, randomized, double-blind trial is the comparison of the efficacy of the treatment on the disappearance of warts at the end of treatment (6-month visit) between the 2LVERU® JUNIOR and 2LVERU® versus the placebo group.

The study duration will be maximum 45 months with 36 months of inclusion and 9 months of follow-up.

Patients aged 3 years and older who present common warts (Verruca vulgaris), and/or plantar warts (Verruca plantaris), and/or flat warts (Verruca plana) during a visit with their dermatologist/general practitioner.

The total number of patients to include will be 162.

Primary objective:

Comparison of the efficacy of the treatment on the disappearance of warts at the end of treatment (6-month visit) between the 2LVERU® JUNIOR and 2LVERU® versus the placebo group.

Secondary objectives

* Comparison of the efficacy of the treatment on the disappearance of warts at 4 months between groups.
* Comparison of the efficacy of the treatment on the level of disappearance (4 levels) of warts at 4 months and 6 months (end of the treatment) between groups
* Comparison of the efficacy of the treatment on the recurrence of warts 3 months after the end of treatment between groups
* Compare the pain related to warts during the study between groups
* Safety issues.

Treatment phase:

* Group n°1 = 2LVERU® JUNIOR / 2LVERU® (6 months of treatment)
* Group n°2 = Placebo (6 months of treatment)

Post-treatment Follow-up phase: 3 months

Treatment will be considered successful if the following three criteria are met for all treated warts as described at the baseline visit:

* Normal skin colour at the wart site
* Normal skin texture at the wart site
* Normal touch at the wart site Treatment will be considered a failure, at the end of the treatment, if at least one of the above three criteria is not met for all treated warts as described at the baseline visit.

Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts

Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.

A wart will be considered as disappeared if the colour and texture of the skin has returned to normal and can no longer be felt to the touch.

Minimum value: 0 (better outcome) Maximum Value: 10 (worse outcome)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts	NCT04290572	Flat Wart	Isotretinoin ca...	18 Years - 40 Years	Centro Dermatológico Dr. Ladislao de la Pascua
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts	NCT03977753	Common Wart Flat Wart Plantar Wart	2LVERU® or 2LVE... Placebo	3 Years -	Labo'Life
Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts	NCT04290572	Flat Wart	Isotretinoin ca...	18 Years - 40 Years	Centro Dermatológico Dr. Ladislao de la Pascua
Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts	NCT04290572	Flat Wart	Isotretinoin ca...	18 Years - 40 Years	Centro Dermatológico Dr. Ladislao de la Pascua

Spots Global Cancer Trial Database for flat wart

Every month we try and update this database with for flat wart cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for flat wart

Every month we try and update this database with for flat wart cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for flat wart cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.