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Efficacy and Safety of Neosil on Chronic Effluvium

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ClinicalTrials.gov Identifier: NCT03659201
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Luxbiotech
Information provided by (Responsible Party):
EMS

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

Condition or disease Intervention/treatment Phase
Chronic Telogen Effluvium Drug: Neosil complete Drug: Pantogar Drug: Neosil Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial, Placebo Controlled and Active Comparator, to Evaluate Efficacy and Safety of Neosil in Chronic Effluvium
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

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.




Primary Outcome Measures :
  1. Hair density [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Incidence and severity of adverse events recorded during the study [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659201


Contacts
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Contact: Monalisa Oliveira, M.D. +551938879851 pesquisa.clinica@ems.com.br

Locations
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Brazil
Caep Centro Avancado de Estudos E Pesquisas Ltda Recruiting
Campinas, SP, Brazil, 13083190
Contact: Pedro Serafim Jr, M.D.    +55 193756.6889      
Contact: Angélica Toledo    +55 193756.6889    angelica.toledo@caeplab.com.br   
Sponsors and Collaborators
EMS
Luxbiotech

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT03659201     History of Changes
Other Study ID Numbers: CAEP 0100118PC - Si+Biobetter
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pantothenic Acid
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs