Telogen EffluviumPhase 3NCT04880889
BL3000 Compared to Pantogar® in the Treatment of Telogen Effluvium in Women.
A Phase 3 study testing BL 3000 and Reference Pantogar in people with Telogen Effluvium, run by Biolab Sanus Farmaceutica.
Trial summary
Study phase III, randomized, double-dummy, placebo controlled, single-center, of regarding the non-inferiority of the medication BL3000, when compared to Pantogar® treatment of telogen effluvium in women. Research product: BL3000. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Telogen Effluvium
- What is being tested?
- BL 3000 and Reference Pantogar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 30 Jul 2023
- Phase
- Phase 3
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged from 18 to 45 years old;
- Clinical/trichological evidence of telogen effluvium, assessed using the Telogen Index. 3. Participants will be eligible if they have a rate strand of hair ≥ 20% of the total quantified by Thrichoscan measurement in the central-parietal region;
- Complaint of hair loss for at least 3 months prior to screening;
- Agreement to obey the procedures and requirements of the protocol and to attend the Research Institution on the day (s) and time (s) determined for the evaluations;
- Signature of the Informed Consent Form; SAW. Agreement to use an acceptable non-hormonal contraceptive method throughout the period of treatment and up to 60 days after the end of the study;
- Serum creatinine within the normal range;
- Relationship between AST / ALT transaminases ≤ 2.5x the upper limit of normal
Who cannot join
- Pregnancy or pregnancy risk;
- Lactation;
- Childbirth occurred in the last 12 months;
- Patient who has undergone surgical procedures or has suffered trauma in the last 6 months;
- History of bleeding events in the last 6 months, SAW. Clinical evidence of female androgenic alopecia or alopecia areata;
- Patients with signs of menopause: menstrual irregularities or cycle failure, signs of climacteric;
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- Laboratory evidence of thyroid diseases (variation in TSH and / or free T4 values outside normal limits);
- Clinical evidence of ovarian or adrenal endocrine disorders (polycystic ovaries, hirsutism, menstrual irregularities);
- History or presence of systemic autoimmune disease;
- Start or end of hormone therapy within 6 months before randomization;
- Deficiency diseases;
- Introduction, change or interruption of a hormonal contraceptive method in the last 6 months before randomization;
- Introduction of a restrictive diet in the last 03 months before randomization;
- Use of any continuous medication;
- Diabetes, chronic consuming disease, malabsorptive syndrome or diseases of the gastrointestinal tract;
- Infectious or chronic fever;
- Psychiatric/psychological illnesses, such as depression, anxiety or obsessive disorders;
- Clinical and / or laboratory evidence of anemia or ferropenia; (Hb <12 g / dL and Ferritin <40 g / L);
- Hair treatment to control hair loss (including shampoo, conditioner, lotions);
- Hair growth agent treatment within 3 months before randomization;
- Concomitant use of drugs that cause hair loss;
- Patient with a history of allergic reaction or hypersensitivity to any formulation ingredients;
- Other conditions considered by the evaluating physician to be reasonable for disqualifying the participation in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study Phase III, Randomized, Double-dummy, Placebo Controlled, Single-center, of Regarding the Non-inferiority of the Medication BL3000, When Compared to Pantogar® Treatment of Telogen Effluvium in Women.
Study phase III, randomized, double-dummy, placebo controlled, single-center, of regarding the non-inferiority of the medication BL3000, when compared to Pantogar® treatment of telogen effluvium in women.
Research product: BL3000. Reference product: Pantogar® List of Study Center: MAIN INVESTIGATOR STUDY CENTER FONE Medcin Skin Institute Sérgio Schalka 11 36835357
Read the detailed description
Study phase III, randomized, double-dummy, placebo controlled, single-center, of regarding the non-inferiority of the medication BL3000, when compared to Pantogar® treatment of telogen effluvium in women. 326 female patients will be recruited for the study. They will be aged from 18 to 45 years old, not menopausal, diagnosed with telogen effluvium proven by Trichoscan, who meet the inclusion criteria and do not meet the exclusion criteria and who sign the Informed Consent Form.
Patients will be divided into two treatment groups according to randomization:
Group I: 163 patients will receive treatment with the medication BL3000 and matching placebo of pantogar.
Group II: 163 patients will receive treatment with the reference drug (Pantogar®) and matching placebo of BL3000.
The patients will participate in the study for a period of 199 (one hundred and ninety-nine) days, using of the investigational or comparative product for 180 (one hundred and eighty) days,
- Conditions
- Telogen Effluvium
- Being tested
- BL 3000, Reference Pantogar, BL3000 Placebo, Pantogar - Placebo
- Keywords
- loss of hair
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL 3000Drug
capsule 500 mg
Reference PantogarDrug
capsule
BL3000 PlaceboDrug
capsule 500 mg
Pantogar - PlaceboDrug
capsule
| Study group | Role | What they receive |
|---|---|---|
| BL 3000 (active) and Pantogar matching Placebo | Experimental | One capsule, once a day for 180 days for BL3000 and one capsule three times a day for Pantogar-Placebo. Receives: Drug: BL 3000; Drug: Pantogar - Placebo |
| Pantogar and BL3000 matching placebo | Active comparator | One capsule, three times a day for 180 days Receives: Drug: Reference Pantogar; Drug: BL3000 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate difference of anagen hairs at 180 days (FA vf [%]) from baseline rate (FA vi [%]), in participants of each treatment group.
Assess the non-inferiority of the effectiveness of the BL3000 drug compared to the drug.
The counting of anagen and telogen performed by phototrichogram in the initial and final experimental times, with the calculation proposed according to the protocol below:
The primary variable of efficacy will be the rate of anagen hairs (FA) (%), 45.90 and 180 days in relation to the beginning, between the two arms of treatment (test versus control). Calculated as follows:
FA (vi): result of anagen (%) on visit 04 (T0); FA (vf): result of anagen (%) on visit 10 (T182). Response rate of anagen (%), FA = (FA (vf)-FA (vi)).
Measured: 180 days
Secondary outcomes (8)
Difference of the total count of strand hair per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Difference of the density of the strand hair, in a given area (units per mm2), measured by phototrichogram in the experimental times, compared to the baseline measurement
Measured: 45,90 and 180 days
Difference of the number of anagen hairs per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Difference of the density of anagen hairs, in a given area (units per mm2), measured by phototrichogram in the experimental times, compared to the baseline measurement
Measured: 45,90 and 180 days
Difference of the number of telogen hairs per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Difference of the density of telogen hairs, in a given area (units per mm2), measured by phototrichogram in the experimental times, compared to the baseline measurement
Measured: 45,90 and 180 days
Difference of the anagen/telogen hair ratio at the experimental times frames, compared to the baseline evaluation, in participants of each treatment group.
Difference of the anagen/telogen hair ratio, in a given area (units per mm2), measured by phototrichogram in the experimental times, compared to the baseline measurement
Measured: 45,90 and 180 days
Difference of the strand hair thickness (mm²) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Difference of the thickness of strand hairs, measured by phototrichogram in the experimental times, compared to the baseline measurement
Measured: 45,90 and 180 days
Proportion of "Excellent" and "Very good" change of the telogen effluvium, as assessed by the investigator, comparing photographs taken at final visit and baseline visit, in participants of each treatment group.
Analysis photographs taken during the initial and final visits, the opinion of the evaluator, regarding the improvement of the telogen effluvium:
- - Excellent;
- - Very good;
- - Good;
- - Regular
- - Bad. Analysis global assessment of the investigator, the X2 test will be used to make comparisons between groups. The proportion of Excellent and Very good for Researcher question will be analyzed, the confidence interval with 95% confidence for p1 - p2 will be constructed from the sample distribution of the sample proportion, where p2 is the proportion of Excellent and Very good by Pantogar for Researcher question and p1 is that of the test drug.
Measured: 180 days
Proportion of "Much better" and "best" change, based on the participant's subjective assessment, from each treatment group, using a Likert scale.
Participants will present their opinion on the effectiveness of the treatment, using a Likert scale from 1 to 4:
Considering the evolution of the treatment, what is your opinion about the amount of hair strands at the end of the treatment.
1 - Much better; 2 - Best; 3 - No change and 4 - Worse. To analyze Subjective evaluation of the patient, the X2 test will be used to make comparisons between groups.
The proportion of Much better and Best for patient question will be analyzed, the confidence interval with 95% confidence for p1 - p2 will be constructed from the sample distribution of the sample proportion, where p2 is the proportion of Very best and Best of Pantogar for patient question and p1 is that of the test drug.
Measured: 45,90 and 180 days
Number of participants with treatment-related adverse events in each treatment group
Safety and tolerability evaluation based on the occurrence of adverse events in each treatment group.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Jan 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telogen EffluviumStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study phase III, randomized, double-dummy, placebo controlled, single-center, of regarding the non-inferiority of the medication BL3000, when compared to Pantogar® treatment of telogen effluvium in women.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sérgio Schalka, Principal investigator, Medcin Instituto da Pele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880889
- Sponsor's protocol ID
- LP165762
- Status last verified
- Jul 2022
- First submitted
- 1 Mar 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Phase III, Randomized, Double-dummy, Placebo Controlled, Single-center, of Regarding the Non-inferiority of the Medication BL3000, When Compared to Pantogar® Treatment of Telogen Effluvium in Women.
- ClinicalTrials.gov ID
- NCT04880889
- Acronym / sponsor ID
- LP165762
- Conditions
- Telogen Effluvium
- Keywords
- loss of hair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 11 May 2021 (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.
Study phase III, randomized, double-dummy, placebo controlled, single-center, of regarding the non-inferiority of the medication BL3000, when compared to Pantogar® treatment of telogen effluvium in women.
Research product: BL3000. Reference product: Pantogar® List of Study Center: MAIN INVESTIGATOR STUDY CENTER FONE Medcin Skin Institute Sérgio Schalka 11 36835357
Detailed description
Study phase III, randomized, double-dummy, placebo controlled, single-center, of regarding the non-inferiority of the medication BL3000, when compared to Pantogar® treatment of telogen effluvium in women. 326 female patients will be recruited for the study. They will be aged from 18 to 45 years old, not menopausal, diagnosed with telogen effluvium proven by Trichoscan, who meet the inclusion criteria and do not meet the exclusion criteria and who sign the Informed Consent Form.
Patients will be divided into two treatment groups according to randomization:
Group I: 163 patients will receive treatment with the medication BL3000 and matching placebo of pantogar.
Group II: 163 patients will receive treatment with the reference drug (Pantogar®) and matching placebo of BL3000.
The patients will participate in the study for a period of 199 (one hundred and ninety-nine) days, using of the investigational or comparative product for 180 (one hundred and eighty) days,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study phase III, randomized, double-dummy, placebo controlled, single-center, of regarding the non-inferiority of the medication BL3000, when compared to Pantogar® treatment of telogen effluvium in women.
| Arm | Type | Receives |
|---|---|---|
| BL 3000 (active) and Pantogar matching Placebo | Experimental | Drug: BL 3000, Drug: Pantogar - PlaceboOne capsule, once a day for 180 days for BL3000 and one capsule three times a day for Pantogar-Placebo. |
| Pantogar and BL3000 matching placebo | Active comparator | Drug: Reference Pantogar, Drug: BL3000 PlaceboOne capsule, three times a day for 180 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female patients aged from 18 to 45 years old;
- Clinical/trichological evidence of telogen effluvium, assessed using the Telogen Index. 3. Participants will be eligible if they have a rate strand of hair ≥ 20% of the total quantified by Thrichoscan measurement in the central-parietal region;
- Complaint of hair loss for at least 3 months prior to screening;
- Agreement to obey the procedures and requirements of the protocol and to attend the Research Institution on the day (s) and time (s) determined for the evaluations;
- Signature of the Informed Consent Form; SAW. Agreement to use an acceptable non-hormonal contraceptive method throughout the period of treatment and up to 60 days after the end of the study;
Key exclusion criteria (23 listed)
- Pregnancy or pregnancy risk;
- Lactation;
- Childbirth occurred in the last 12 months;
- Patient who has undergone surgical procedures or has suffered trauma in the last 6 months;
- History of bleeding events in the last 6 months, SAW. Clinical evidence of female androgenic alopecia or alopecia areata;
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 |
|---|---|---|
| BL 3000capsule 500 mg | Drug | BL 3000 (active) and Pantogar matching Placebo |
| Reference Pantogarcapsule | Drug | Pantogar and BL3000 matching placebo |
| BL3000 Placebocapsule 500 mg | Drug | Pantogar and BL3000 matching placebo |
| Pantogar - Placebocapsule | Drug | BL 3000 (active) and Pantogar matching Placebo |
Primary outcome
Rate difference of anagen hairs at 180 days (FA vf [%]) from baseline rate (FA vi [%]), in participants of each treatment group.
Time frame: 180 days
Assess the non-inferiority of the effectiveness of the BL3000 drug compared to the drug. The counting of anagen and telogen performed by phototrichogram in the initial and final experimental times, with the calculation proposed according to the protocol below: The primary variable of efficacy will be the rate of anagen hairs (FA) (%), 45.90 and 180 days in relation to the beginning, between the two arms of treatment (test versus control). Calculated as follows: FA (vi): result of anagen (%) on visit 04 (T0); FA (vf): result of anagen (%) on visit 10 (T182). Response rate of anagen (%), FA = (FA (vf)-FA (vi)).
8 secondary outcomes
Difference of the total count of strand hair per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Time frame: 45,90 and 180 days
Difference of the number of anagen hairs per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Time frame: 45,90 and 180 days
Difference of the number of telogen hairs per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Time frame: 45,90 and 180 days
Difference of the anagen/telogen hair ratio at the experimental times frames, compared to the baseline evaluation, in participants of each treatment group.
Time frame: 45,90 and 180 days
Difference of the strand hair thickness (mm²) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Time frame: 45,90 and 180 days
Proportion of "Excellent" and "Very good" change of the telogen effluvium, as assessed by the investigator, comparing photographs taken at final visit and baseline visit, in participants of each treatment group.
Time frame: 180 days
Proportion of "Much better" and "best" change, based on the participant's subjective assessment, from each treatment group, using a Likert scale.
Time frame: 45,90 and 180 days
Number of participants with treatment-related adverse events in each treatment group
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
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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.
Sérgio Schalka principal investigator
Medcin Instituto da Pele
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BL 3000 and Reference Pantogar in people with Telogen Effluvium, run by Biolab Sanus Farmaceutica.
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 7 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sérgio Schalka, I (55 - 11 3683-5366, sergio.schalka@medcin.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate difference of anagen hairs at 180 days (FA vf [%]) from baseline rate (FA vi [%]), in participants of each treatment group. (time frame: 180 days). 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 8 Jul 2022.