search
Back to results

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
Biolab Sanus Farmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telogen Effluvium focused on measuring loss of hair

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female patients aged from 18 to 45 years old;
  2. 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;
  3. Complaint of hair loss for at least 3 months prior to screening;
  4. 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;
  5. 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;
  6. Serum creatinine within the normal range;
  7. Relationship between AST / ALT transaminases ≤ 2.5x the upper limit of normal

Exclusion Criteria:

  1. Pregnancy or pregnancy risk;
  2. Lactation;
  3. Childbirth occurred in the last 12 months;
  4. Patient who has undergone surgical procedures or has suffered trauma in the last 6 months;
  5. History of bleeding events in the last 6 months, SAW. Clinical evidence of female androgenic alopecia or alopecia areata;
  6. Patients with signs of menopause: menstrual irregularities or cycle failure, signs of climacteric;
  7. Laboratory evidence of thyroid diseases (variation in TSH and / or free T4 values outside normal limits);
  8. Clinical evidence of ovarian or adrenal endocrine disorders (polycystic ovaries, hirsutism, menstrual irregularities);
  9. History or presence of systemic autoimmune disease;
  10. Start or end of hormone therapy within 6 months before randomization;
  11. Deficiency diseases;
  12. Introduction, change or interruption of a hormonal contraceptive method in the last 6 months before randomization;
  13. Introduction of a restrictive diet in the last 03 months before randomization;
  14. Use of any continuous medication;
  15. Diabetes, chronic consuming disease, malabsorptive syndrome or diseases of the gastrointestinal tract;
  16. Infectious or chronic fever;
  17. Psychiatric/psychological illnesses, such as depression, anxiety or obsessive disorders;
  18. Clinical and / or laboratory evidence of anemia or ferropenia; (Hb <12 g / dL and Ferritin <40 g / L);
  19. Hair treatment to control hair loss (including shampoo, conditioner, lotions);
  20. Hair growth agent treatment within 3 months before randomization;
  21. Concomitant use of drugs that cause hair loss;
  22. Patient with a history of allergic reaction or hypersensitivity to any formulation ingredients;
  23. 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

    First Posted
    March 1, 2021
    Last Updated
    July 5, 2022
    Sponsor
    Biolab Sanus Farmaceutica
    search

    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.

    We'll reach out to this number within 24 hrs