Melagenina Plus - Vitiligo – phase IV

Phase 4

• Conditions: Vitiligo; Hypopigmentation; Skin Diseases; Skin and Connective Tissue Diseases; Pigmentation Disorders; Skin Pigmentation

• Registration Number: RPCEC00000297
• Lead Sponsor: Placental Histotherapy Center Dr. Carlos Manuel Miyares Cao (CHP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 244

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.