Overview

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.