Efficacy and Safety of Neosil on Chronic Effluvium

EMS

Status and phase: Completed; Phase 4

Conditions: Chronic Telogen Effluvium

Treatments: Drug: Neosil complete; Drug: Pantogar; Drug: Neosil

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03659201

CAEP 0100118PC - Si+Biobetter

Details and patient eligibility

About

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

Enrollment: 232 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 3 patient groups

Neosil complete

Experimental group

Description:

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.

Treatment:

Drug: Neosil complete

Pantogar

Experimental group

Description:

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.

Treatment:

Drug: Pantogar

Neosil

Experimental group

Description:

The patient will take the tablets, as follow: 2 tablets of Neosil Oral, per day - during the 12 weeks.

Treatment:

Drug: Neosil