Status:
UNKNOWN
BL3000 Compared to Pantogar® in the Treatment of Telogen Effluvium in Women.
Lead Sponsor:
Biolab Sanus Farmaceutica
Conditions:
Telogen Effluvium
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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 wo...
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 wo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT04880889
Start Date
January 1 2023
End Date
July 30 2023
Last Update
July 8 2022
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