Efficacy and Safety of Neosil on Chronic Effluvium

NCT ID: NCT03659201

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2020-03-30

Brief Summary

The purpose of this study is to evaluate the efficacy of Neosil in the treatment of chronic effluvium

Conditions

Chronic Telogen Effluvium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neosil complete

The patient will take the tablets, as follow:

3 tablets of Neosil, Oral, per day - during the initial 12 weeks; and

2 tablets of Neosil Oral, per day - during the last 12 weeks.

Group Type: EXPERIMENTAL

Neosil complete

Intervention Type: DRUG

Oral, during 24 weeks.

Pantogar

The patient wil take the tablets, as follow:

3 tablets of Placebo, Oral, per day - during the initial 12 weeks; and

3 tablets of Pantogar, Oral, per day - during the last 12 weeks.

Group Type: EXPERIMENTAL

Pantogar

Intervention Type: DRUG

Oral, placebo for 12 weeks and pantogar for 12 weeks.

Neosil

The patient will take the tablets, as follow:

2 tablets of Neosil Oral, per day - during the 12 weeks.

Group Type: EXPERIMENTAL

Neosil

Intervention Type: DRUG

Oral, during only 12 weeks.

Interventions

Neosil complete

Oral, during 24 weeks.

Intervention Type: DRUG

Pantogar

Oral, placebo for 12 weeks and pantogar for 12 weeks.

Intervention Type: DRUG

Neosil

Oral, during only 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants who present hair loss for more than 6 months;
• Do not use other possible cosmetic or dermatological treatments, during the trial;
• Not change the diet during the trial and not be any restrictive diet during this period.

Exclusion Criteria

• Pregnancy or risk of pregnancy and lactating patients;
• Use of any products to promote hair growth within the 6 months prior to the Baseline Visit;
• History of hair transplants;
• Current skin disease;
• History hypersensitivity to the active ingredients used in the study;
• Participation in clinical trial in the year prior to this study;
• Known history of non controled systemic disease (diabetes, hypertension, anemia, iron deficiency, and others);
• Gastric diseases;
• Smoker;
• History of systemic disease (HIV, non specify autoimmune disease, hepatitis, and others).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Luxbiotech

UNKNOWN

Sponsor Role: collaborator

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Caep Centro Avancado de Estudos E Pesquisas Ltda

Campinas, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CAEP 0100118PC - Si+Biobetter

Identifier Type: -

Identifier Source: org_study_id