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

Telogen Effluvium Clinical Trial

Official title:
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 Not yet recruiting

Clinical Trial 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

Clinical Trial 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, ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04880889
Study type	Interventional
Source	Biolab Sanus Farmaceutica
Contact	Sérgio Schalka, I
Phone	55 - 11 3683-5366
Email	sergio.schalka@medcin.com.br
Status	Not yet recruiting
Phase	Phase 3
Start date	January 1, 2023
Completion date	July 30, 2023

View Details

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