Efficacy and Safety of Neosil on Chronic Effluvium

NCT03659201 | Completed Phase 4 DMC

• 1 other identifier: CAEP 0100118PC - Si+Biobetter
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Telogen Effluvium

Outcome Measures

Primary Outcomes (1)

• Hair density

  24 weeks

Secondary Outcomes (1)

• Incidence and severity of adverse events recorded during the study

  24 weeks

Study Arms (3)

Neosil complete

EXPERIMENTAL

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.

Drug: Neosil complete

Pantogar

EXPERIMENTAL

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.

Drug: Pantogar

Neosil

EXPERIMENTAL

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

Drug: Neosil

Interventions

Neosil complete DRUG

Oral, during 24 weeks.

Neosil complete

Pantogar DRUG

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

Pantogar

Neosil DRUG

Oral, during only 12 weeks.

Neosil

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• EMS: lead
• Luxbiotech: collaborator

Study Sites (1)

Caep Centro Avancado de Estudos E Pesquisas Ltda

Campinas, São Paulo, 13083190, Brazil

Location

MeSH Terms

Interventions

pantogar

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 6, 2018
• Study Start: September 3, 2018
• Primary Completion: June 4, 2019
• Study Completion: March 30, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

BR (1)