A Phase 3 interventional study of BL 3000 and Reference Pantogar in Telogen Effluvium, sponsored by Biolab Sanus Farmaceutica. Status unknown. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-07-08.
Sponsored by Biolab Sanus Farmaceutica · Phase 3, Interventional, and Treatment
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
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,
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's planned enrollment of 326 is above the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →Biolab Sanus Farmaceutica is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One capsule, once a day for 180 days for BL3000 and one capsule three times a day for Pantogar-Placebo.
Drug: BL 3000 · Drug: Pantogar - Placebo
One capsule, three times a day for 180 days
Drug: Reference Pantogar · Drug: BL3000 Placebo
capsule 500 mg
capsule
capsule 500 mg
capsule
Rate difference of anagen hairs at 180 days (FA vf [%]) from baseline rate (FA vi [%]), in participants of each treatment group.
Assess the non-inferiority of the effectiveness of the BL3000 drug compared to the drug. The counting of anagen and telogen performed by phototrichogram in the initial and final experimental times, with the calculation proposed according to the protocol below: The primary variable of efficacy will be the rate of anagen hairs (FA) (%), 45.90 and 180 days in relation to the beginning, between the two arms of treatment (test versus control). Calculated as follows: FA (vi): result of anagen (%) on visit 04 (T0); FA (vf): result of anagen (%) on visit 10 (T182). Response rate of anagen (%), FA = (FA (vf)-FA (vi)).
Time frame: 180 days
Difference of the total count of strand hair per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Difference of the density of the strand hair, in a given area (units per mm2), measured by phototrichogram in the experimental times, compared to the baseline measurement
Time frame: 45,90 and 180 days
Difference of the number of anagen hairs per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Difference of the density of anagen hairs, in a given area (units per mm2), measured by phototrichogram in the experimental times, compared to the baseline measurement
Time frame: 45,90 and 180 days
Difference of the number of telogen hairs per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Difference of the density of telogen hairs, in a given area (units per mm2), measured by phototrichogram in the experimental times, compared to the baseline measurement
Time frame: 45,90 and 180 days
Difference of the anagen/telogen hair ratio at the experimental times frames, compared to the baseline evaluation, in participants of each treatment group.
Difference of the anagen/telogen hair ratio, in a given area (units per mm2), measured by phototrichogram in the experimental times, compared to the baseline measurement
Time frame: 45,90 and 180 days
Difference of the strand hair thickness (mm²) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.
Difference of the thickness of strand hairs, measured by phototrichogram in the experimental times, compared to the baseline measurement
Time frame: 45,90 and 180 days
Proportion of "Excellent" and "Very good" change of the telogen effluvium, as assessed by the investigator, comparing photographs taken at final visit and baseline visit, in participants of each treatment group.
Analysis photographs taken during the initial and final visits, the opinion of the evaluator, regarding the improvement of the telogen effluvium: 1. - Excellent; 2. - Very good; 3. - Good; 4. - Regular 5. - Bad. Analysis global assessment of the investigator, the X2 test will be used to make comparisons between groups. The proportion of Excellent and Very good for Researcher question will be analyzed, the confidence interval with 95% confidence for p1 - p2 will be constructed from the sample distribution of the sample proportion, where p2 is the proportion of Excellent and Very good by Pantogar for Researcher question and p1 is that of the test drug.
Time frame: 180 days
Proportion of "Much better" and "best" change, based on the participant's subjective assessment, from each treatment group, using a Likert scale.
Participants will present their opinion on the effectiveness of the treatment, using a Likert scale from 1 to 4: Considering the evolution of the treatment, what is your opinion about the amount of hair strands at the end of the treatment. 1 - Much better; 2 - Best; 3 - No change and 4 - Worse. To analyze Subjective evaluation of the patient, the X2 test will be used to make comparisons between groups. The proportion of Much better and Best for patient question will be analyzed, the confidence interval with 95% confidence for p1 - p2 will be constructed from the sample distribution of the sample proportion, where p2 is the proportion of Very best and Best of Pantogar for patient question and p1 is that of the test drug.
Time frame: 45,90 and 180 days
Number of participants with treatment-related adverse events in each treatment group
Safety and tolerability evaluation based on the occurrence of adverse events in each treatment group.
Time frame: 180 days
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Biolab Sanus Farmaceutica