Efficacy and Safety of Neosil on Chronic Effluvium

Randomized Clinical Trial, Placebo Controlled and Active Comparator, to Evaluate Efficacy and Safety of Neosil in Chronic Effluvium

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

Study Overview

• Status: Completed
• Conditions: Chronic Telogen Effluvium
• Intervention / Treatment: Drug: Neosil complete; Drug: Pantogar; Drug: Neosil

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Campinas, SP, Brazil, 13083190
      • Caep Centro Avancado de Estudos E Pesquisas Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Neosil complete; Oral, during 24 weeks.
Experimental: 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.	Drug: Pantogar; Oral, placebo for 12 weeks and pantogar for 12 weeks.
Experimental: Neosil; The patient will take the tablets, as follow: 2 tablets of Neosil Oral, per day - during the 12 weeks.	Drug: Neosil; Oral, during only 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hair density	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events recorded during the study	24 weeks

Collaborators and Investigators

• Sponsor: EMS
• Collaborators: Luxbiotech

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2018
• Primary Completion (Actual): June 4, 2019
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: September 3, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CAEP 0100118PC - Si+Biobetter

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No