Evaluation of the effectiveness and safety of melagenina plus in the treatment of patients with vitiligo. Phase IV.

Placental Histotherapy Center Dr. Carlos Manuel Miyares Cao (CHP)0 个研究点目标入组 244 人开始时间: 2019年1月14日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1. Patients with a clinical and histological diagnosis of Vitiligo.
•2. Patients of any sex and age between 2-60 years, inclusive.
•3. Patients with depigmented areas between 1 and 40%.
•4. Adult patients, mother, father or legal guardian who grant consent to participate in the study in writing. Patients between 2 and 11 years old (including both ages) who grant their consent to participate. Patients between 12 and 18 years old (including both ages) who give their informed consent together with the responsible adult.

•1. Pregnant or lactating patients.
•2. Patients with infectious disease associated with skin at the time of inclusion.
•3. Patients with severe chronic disease requiring treatment with steroids.
•4. Patients with psychiatric illnesses that could limit adherence to the requirements of the trial.
•5. Patients with known immunosuppression history.
•6. Patients who in 45 days prior to their assessment for inclusion in the study have received some treatment: immunopresors, topical or systemic corticosteroids, cyclosporine, UVA phototherapy or combined with psoralen, cytostatics.
•7. Patients with oral or systemic contraceptive treatment.
•8. Patients presenting chronic dermatitis with a depigmentary character or endocrine diseases that cause disorders in pigmentation (mainly Addison's disease, thyroid diseases and hypopitutarism).

发起方

Placental Histotherapy Center Dr. Carlos Manuel Miyares Cao (CHP)