Chronic Telogen EffluviumPhase 4NCT03659201
Efficacy and Safety of Neosil on Chronic Effluvium
A Phase 4 study testing Neosil complete, Pantogar and Neosil in people with Chronic Telogen Effluvium, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of Neosil in the treatment of chronic effluvium Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Telogen Effluvium
- What is being tested?
- Neosil complete, Pantogar and Neosil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Sep 2018to 30 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Caep Centro Avancado de Estudos E Pesquisas Ltda
Campinas, São Paulo, 13083190
About this study
Official title: 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
- Conditions
- Chronic Telogen Effluvium
- Being tested
- Neosil complete, Pantogar, Neosil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neosil completeDrug
Oral, during 24 weeks.
PantogarDrug
Oral, placebo for 12 weeks and pantogar for 12 weeks.
NeosilDrug
Oral, during only 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Pantogar |
| Neosil | Experimental | The patient will take the tablets, as follow:
2 tablets of Neosil Oral, per day - during the 12 weeks. Receives: Drug: Neosil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair density
Measured: 24 weeks
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start3 Sep 2018
- Primary completion4 Jun 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Telogen EffluviumStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Luxbiotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659201
- Sponsor's protocol ID
- CAEP 0100118PC - Si+Biobetter
- Status last verified
- Apr 2020
- First submitted
- 3 Sep 2018
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial, Placebo Controlled and Active Comparator, to Evaluate Efficacy and Safety of Neosil in Chronic Effluvium
- ClinicalTrials.gov ID
- NCT03659201
- Acronym / sponsor ID
- CAEP 0100118PC - Si+Biobetter
- Conditions
- Chronic Telogen Effluvium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Collaborators
- Luxbiotech
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of Neosil in the treatment of chronic effluvium
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neosil complete | Experimental | Drug: Neosil completeThe 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. |
| Pantogar | Experimental | Drug: PantogarThe 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. |
| Neosil | Experimental | Drug: NeosilThe patient will take the tablets, as follow: 2 tablets of Neosil Oral, per day - during the 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neosil completeOral, during 24 weeks. | Drug | Neosil complete |
| PantogarOral, placebo for 12 weeks and pantogar for 12 weeks. | Drug | Pantogar |
| NeosilOral, during only 12 weeks. | Drug | Neosil |
Primary outcome
Hair density
Time frame: 24 weeks
1 secondary outcome
Incidence and severity of adverse events recorded during the study
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neosil complete, Pantogar and Neosil in people with Chronic Telogen Effluvium, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair density (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.