BL3000 Compared to Pantogar® in the Treatment of Telogen Effluvium in Women.
Primary Purpose
Telogen Effluvium
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BL 3000
Reference Pantogar
BL3000 Placebo
Pantogar - Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Telogen Effluvium focused on measuring loss of hair
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BL 3000 (active) and Pantogar matching Placebo
Pantogar and BL3000 matching placebo
Arm Description
One capsule, once a day for 180 days for BL3000 and one capsule three times a day for Pantogar-Placebo.
One capsule, three times a day for 180 days
Outcomes
Primary Outcome Measures
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)).
Secondary Outcome Measures
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
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
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
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
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04880889
Brief Title
BL3000 Compared to Pantogar® in the Treatment of Telogen Effluvium in Women.
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 Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biolab Sanus Farmaceutica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telogen Effluvium
Keywords
loss of hair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-dummy
Allocation
Randomized
Enrollment
326 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BL 3000 (active) and Pantogar matching Placebo
Arm Type
Experimental
Arm Description
One capsule, once a day for 180 days for BL3000 and one capsule three times a day for Pantogar-Placebo.
Arm Title
Pantogar and BL3000 matching placebo
Arm Type
Active Comparator
Arm Description
One capsule, three times a day for 180 days
Intervention Type
Drug
Intervention Name(s)
BL 3000
Intervention Description
capsule 500 mg
Intervention Type
Drug
Intervention Name(s)
Reference Pantogar
Intervention Description
capsule
Intervention Type
Drug
Intervention Name(s)
BL3000 Placebo
Intervention Description
capsule 500 mg
Intervention Type
Drug
Intervention Name(s)
Pantogar - Placebo
Intervention Description
capsule
Primary Outcome Measure Information:
Title
Rate difference of anagen hairs at 180 days (FA vf [%]) from baseline rate (FA vi [%]), in participants of each treatment group.
Description
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)).
Time Frame
180 days
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
45,90 and 180 days
Title
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.
Description
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
Time Frame
45,90 and 180 days
Title
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.
Description
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
Time Frame
45,90 and 180 days
Title
Difference of the anagen/telogen hair ratio at the experimental times frames, compared to the baseline evaluation, in participants of each treatment group.
Description
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
Time Frame
45,90 and 180 days
Title
Difference of the strand hair thickness (mm²) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Description
Difference of the thickness of strand hairs, measured by phototrichogram in the experimental times, compared to the baseline measurement
Time Frame
45,90 and 180 days
Title
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.
Description
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.
Time Frame
180 days
Title
Proportion of "Much better" and "best" change, based on the participant's subjective assessment, from each treatment group, using a Likert scale.
Description
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.
Time Frame
45,90 and 180 days
Title
Number of participants with treatment-related adverse events in each treatment group
Description
Safety and tolerability evaluation based on the occurrence of adverse events in each treatment group.
Time Frame
180 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sérgio Schalka, I
Phone
55 - 11 3683-5366
Email
sergio.schalka@medcin.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Egle Oppi
Phone
55 11 3573-6321
Email
ecosta@biolabfarma.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sérgio Schalka
Organizational Affiliation
Medcin Instituto da Pele
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
BL3000 Compared to Pantogar® in the Treatment of Telogen Effluvium in Women.
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