BL3000 Compared to Pantogar® in the Treatment of Telogen Effluvium in Women.

NCT04880889 | Unknown Phase 3

• 1 other identifier: LP165762
• Study Type: interventional
• Target: 326
• Locations: 0 countries
• Sites: N/A

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

Conditions

Telogen Effluvium

Keywords

loss of hair

Outcome Measures

Primary Outcomes (1)

• 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)).

  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.

  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.

  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.

  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.

  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.

  45,90 and 180 days

Study Arms (2)

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.

Drug: BL 3000; Drug: Pantogar - Placebo

Pantogar and BL3000 matching placebo

ACTIVE COMPARATOR

One capsule, three times a day for 180 days

Drug: Reference Pantogar; Drug: BL3000 Placebo

Interventions

BL 3000 DRUG

capsule 500 mg

BL 3000 (active) and Pantogar matching Placebo

Reference Pantogar DRUG

capsule

Pantogar and BL3000 matching placebo

BL3000 Placebo DRUG

capsule 500 mg

Pantogar and BL3000 matching placebo

Pantogar - Placebo DRUG

capsule

BL 3000 (active) and Pantogar matching Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Biolab Sanus Farmaceutica: lead

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sérgio Schalka

  Medcin Instituto da Pele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sérgio Schalka, I

CONTACT

55 - 11 3683-5366; sergio.schalka@medcin.com.br

Egle Oppi

CONTACT

55 11 3573-6321; ecosta@biolabfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-dummy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: March 1, 2021
• First Posted: May 11, 2021
• Study Start: January 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: July 8, 2022

Record last verified: 2022-07