Efficacy and Safety of Neosil on Chronic Effluvium

Chronic Telogen Effluvium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659201
• Other study ID #: CAEP 0100118PC - Si+Biobetter
• Status: Completed
• Phase: Phase 4
• Start date: September 3, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: April 2020
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: March 30, 2020
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Telogen Effluvium

Intervention

Drug:
• Neosil complete
Oral, during 24 weeks.
• Pantogar
Oral, placebo for 12 weeks and pantogar for 12 weeks.
• Neosil
Oral, during only 12 weeks.

Locations

Country	Name	City	State
Brazil	Caep Centro Avancado de Estudos E Pesquisas Ltda	Campinas	SP

Sponsors (2)

Lead Sponsor	Collaborator
EMS	Luxbiotech

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair density		24 weeks
Secondary	Incidence and severity of adverse events recorded during the study		24 weeks