Last updated: July 5, 2022
Sponsor: Biolab Sanus Farmaceutica
Overall Status: Active - Not Recruiting
Phase
3
Condition
Hair Loss
Alopecia
Scalp Disorders
Treatment
N/AClinical Study ID
NCT04880889
LP165762
Ages 18-45 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Female patients aged from 18 to 45 years old;
- Clinical/trichological evidence of telogen effluvium, assessed using the TelogenIndex. 3. Participants will be eligible if they have a rate strand of hair ≥ 20% ofthe 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 theResearch Institution on the day (s) and time (s) determined for the evaluations;
- Signature of the Informed Consent Form; SAW. Agreement to use an acceptablenon-hormonal contraceptive method throughout the period of treatment and up to 60 daysafter the end of the study;
- Serum creatinine within the normal range;
- Relationship between AST / ALT transaminases ≤ 2.5x the upper limit of normal
Exclusion
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 6months;
- History of bleeding events in the last 6 months, SAW. Clinical evidence of femaleandrogenic alopecia or alopecia areata;
- Patients with signs of menopause: menstrual irregularities or cycle failure, signs ofclimacteric;
- Laboratory evidence of thyroid diseases (variation in TSH and / or free T4 valuesoutside 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 6months 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 thegastrointestinal tract;
- Infectious or chronic fever;
- Psychiatric/psychological illnesses, such as depression, anxiety or obsessivedisorders;
- Clinical and / or laboratory evidence of anemia or ferropenia; (Hb <12 g / dL andFerritin <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 formulationingredients;
- Other conditions considered by the evaluating physician to be reasonable fordisqualifying the participation in the study.
Study Design
Total Participants: 326
Study Start date:
January 01, 2023
Estimated Completion Date:
July 30, 2023