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

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

A study, phase III, randomized, single-center, of regarding the non-inferiority of the Medication BL3000, when compared to Pantogar® in the 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biolab Sanus Farmaceutica

Criteria

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.