Trials / Unknown
UnknownNCT04880889
BL3000 Compared to Pantogar® in the Treatment of Telogen Effluvium in Women.
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.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 326 (estimated)
- Sponsor
- Biolab Sanus Farmaceutica · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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
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 women. 326 female patients will be recruited for the study. They will be aged from 18 to 45 years old, not menopausal, diagnosed with telogen effluvium proven by Trichoscan, who meet the inclusion criteria and do not meet the exclusion criteria and who sign the Informed Consent Form. Patients will be divided into two treatment groups according to randomization: Group I: 163 patients will receive treatment with the medication BL3000 and matching placebo of pantogar. Group II: 163 patients will receive treatment with the reference drug (Pantogar®) and matching placebo of BL3000. The patients will participate in the study for a period of 199 (one hundred and ninety-nine) days, using of the investigational or comparative product for 180 (one hundred and eighty) days,
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BL 3000 | capsule 500 mg |
| DRUG | Reference Pantogar | capsule |
| DRUG | BL3000 Placebo | capsule 500 mg |
| DRUG | Pantogar - Placebo | capsule |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2023-07-30
- Completion
- 2023-07-30
- First posted
- 2021-05-11
- Last updated
- 2022-07-08
Source: ClinicalTrials.gov record NCT04880889. Inclusion in this directory is not an endorsement.