Vitiligo
Conditions
Interventions
Group I Melagenina Plus® (Experimental): Melagenina Plus® by topical route every day, on a daily basis, with intervals of 24 hours, until completing 2 years.
Placental Extracts
Dermatologic Agents
Melagenina Plus,
Lotion
Sponsors
Placental Histotherapy Center "Dr. Carlos Manuel Miyares Cao" (CHP)
Eligibility
Sex/Gender
All
Age
2 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Repigmentation of the affected area ( Using the Vitiligo area scoring index (VASI Questionnaire) and, the categories “Total repigmentation”, “Notable repigmentation”, “Partial repigmentation”, “Same”, “New injuries"). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and, 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes at the level of the spot (With changes, No Changes). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and, 24 months. 2. Time to repigmentation (Time from the patient recruitment until repigmentation of 75% or more of the total area initially affected). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and, 24 months. 3. Stabilization of the disease (Time from the patient reaches a repigmentation of 75% or more of the total area initially affected until that percentage decreases or new lesions appear. The maintenance of 80% of the repigmented lesions for 6 months or more will be considered treatment success). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and, 24 months. 4. Quality of Life (Index of Quality of life measure by the Dermatology Life Quality Index-DLQI questionnaire). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and, 24 months. 5. Adverse events-AE (Occurrence of adverse event (Yes, No), Description of the AE (Name of the AE), Duration of the AE (Date, time of begin and end of the AE, if the data is available), Intensity (Mild, Moderate, Severe), Seriousness (Serious, Not serious), Attitude towards the drug (changes, modification of the dose, temporary interruption, definitive interruption of the treatment), Result (recovered, improved, persists, left sequels), Causal relationship (very probable, probable, possible, unlikely, unrelated, non-assessable/unclassifiable)). Measurement time: 3, 6, 9, 12, 15, 18, 21 and, 24 months. | — |
Countries
Cuba
Contacts
Public ContactIvis Mendoza Hernandez
National Coordinator Center of Clinical Trials (CENCEC)
Outcome results
None listed