18 and older, any sex, with Chemotherapy-Induced Alopecia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dose-limiting Toxicities (DLT) of Topical Compound 31543Primary· 28 days
DLTs were graded according to the CTCAE v4.0. A DLT was defined as a clinically significant Grade 3 or 4 (severe or life-threatening, respectively) non-hematologic toxicity occurring during the first 28-day treatment cycle, and determined to be possibly, probably, or definitely related to BPM31543 and not the taxane-based regimen as best determined by investigators.
Group
Value
95% CI
Compound 31543 Calcitriol - 5 μg/mL
0
Compound 31543 Calcitriol - 10 μg/mL
0
Compound 31543 Calcitriol - 20 μg/mL
0
Compound 31543 Calcitriol - 40 μg/mL
0
Compound 31543 Calcitriol - 60 μg/mL
0
Compound 31543 Calcitriol - 80 μg/mL
0
Pre-dose Concentrations of Compound 31543Secondary· pre-dose on day 1 of Week 1
Pre-dose concentrations of Compound 31543 from serum samples collected on Week 1 Day 1.
Group
Value
95% CI
Compound 31543 Calcitriol - 5 ug/mL
49.0
± 5.8
Compound 31543 Calcitriol - 10 ug/mL
43.2
± 14.8
Compound 31543 Calcitriol - 20 ug/mL
54.3
± 31.5
Compound 31543 Calcitriol - 40 ug/mL
58.4
± 19.4
Compound 31543 Calcitriol - 60 ug/mL
32.8
± 5.2
Compound 31543 Calcitriol - 80 ug/mL
37.8
± 15.5
Cmax of Compound 31543 on Week 1 Day 1Secondary· 8 hours
Cmax of Compound 31543 was calculated using serum samples collected on Week 1 Day 1 pre-dose and at 2 ± 0.5 hours, 4 ± 0.5 hours, and 8 ± 1 hours post-dose. The 8-hour Week 1 Day 1 sample was collected before the second of the daily doses.
Group
Value
95% CI
5 μg/mL
51.6
± 6.9
10 μg/mL
47.2
± 13.6
20 μg/mL
42.5
± 8.5
40 μg/mL
81.0
± 8.1
60 μg/mL
36.0
± 9.8
80 μg/mL
53.5
± 16.1
AUC0-t of Compound 31543 on Week 1 Day 1Secondary· 8 hours
Area under the curve (AUC0-t) of Compound 31543 was calculated from serum samples collected on Week 1 Day 1 pre-dose and at 2 ± 0.5 hours, 4 ± 0.5 hours, and 8 ± 1 hours post-dose. The 8-hour Week 1 Day 1 sample was collected before the second of the daily doses.
Group
Value
95% CI
Compound 31543 Calcitriol - 5 ug/mL
346
± 10
Compound 31543 Calcitriol - 10 ug/mL
334
± 163
Compound 31543 Calcitriol - 20 ug/mL
259
± 60
Compound 31543 Calcitriol - 40 ug/mL
530
± 165
Compound 31543 Calcitriol - 60 ug/mL
230
± 87
Compound 31543 Calcitriol - 80 ug/mL
370
± 99
Top View Photographic Review ScoreSecondary· 7 and 15 weeks
Top of head/scalp view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.
Week 7
Group
Value
95% CI
5 μg/mL
-1
± 0
10 μg/mL
-1.5
± 0.71
20 μg/mL
-1
40 μg/mL
-3
± 0
60 μg/mL
-1
± 0
80 μg/mL
-2
± 1
Week 15
Group
Value
95% CI
5 μg/mL
-2
20 μg/mL
-1
40 μg/mL
-3
60 μg/mL
-2
± 1.41
80 μg/mL
-3
± 0
Right Side Photographic Review ScoreSecondary· 7 and 15 weeks
Right side of head/scalp view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.
Week 7
Group
Value
95% CI
5 μg/mL
-1
± 0
10 μg/mL
-2
20 μg/mL
-1
± 0
40 μg/mL
-2.3
± 1.15
60 μg/mL
-1
± 0
80 μg/mL
-1.7
± 0.58
Week 15
Group
Value
95% CI
5 μg/mL
-2
20 μg/mL
-1.5
± 0.71
40 μg/mL
-3
60 μg/mL
-2
± 1.41
80 μg/mL
-2.5
± .71
Left Side Photographic Review ScoreSecondary· 7 and 15 weeks
Left side of head/scalp view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.
Week 7
Group
Value
95% CI
5 μg/mL
-0.5
± 0.71
10 μg/mL
-1
± 0
20 μg/mL
-1
± 0
40 μg/mL
-2.3
± 1.15
60 μg/mL
-1
± 0
80 μg/mL
-1.7
± 0.58
Week 15
Group
Value
95% CI
5 μg/mL
-2
20 μg/mL
-1.5
± 0.71
40 μg/mL
-3
60 μg/mL
-2
± 1.41
80 μg/mL
-2.5
± 0.71
Front Photographic Review ScoreSecondary· 7 and 15 weeks
Front of head/face view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.
Week 7
Group
Value
95% CI
5 μg/mL
-0.5
± 0.71
10 μg/mL
-0.5
± 0.71
20 μg/mL
-1
± 0
40 μg/mL
-1.7
± 0.58
60 μg/mL
-1
± 0
80 μg/mL
-2.3
± 0.58
Week 15
Group
Value
95% CI
5 μg/mL
-2
20 μg/mL
-1.5
± 0.71
40 μg/mL
-2
60 μg/mL
-2
± 1.41
80 μg/mL
-2.5
± 0.71
Back Photographic Review ScoreSecondary· 7 and 15 weeks
Back of head/face view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.
Week 7
Group
Value
95% CI
5 μg/mL
-0.5
± 0.71
10 μg/mL
-0.5
± 0.71
20 μg/mL
-1
± 0
40 μg/mL
-2
± 1
60 μg/mL
-1
± 0
80 μg/mL
-2
± 1
Week 15
Group
Value
95% CI
5 μg/mL
-2
20 μg/mL
-1
± 0
40 μg/mL
-3
60 μg/mL
-2
± 1.41
80 μg/mL
-2.5
± 0.71
Superior (Mid Pattern) Photographic Review ScoreSecondary· 7 and 15 weeks
Mid-pattern of the scalp from a superior view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.
Week 7
Group
Value
95% CI
5 μg/mL
-1
10 μg/mL
-1
± 0
20 μg/mL
-1
± 0
40 μg/mL
-1.7
± 0.58
60 μg/mL
-0.5
± 0.71
80 μg/mL
-1.7
± 0.58
Week 15
Group
Value
95% CI
20 μg/mL
-1
± 0
40 μg/mL
-2
60 μg/mL
-2
± 1.41
80 μg/mL
-2.5
± 0.71
Vertex Photographic Review ScoreSecondary· 7 and 15 weeks
Vertex view with hair parted in the center at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.
Week 7
Group
Value
95% CI
20 μg/mL
-1
± 0
40 μg/mL
-1.7
± 0.58
60 μg/mL
-0.5
± 0.71
80 μg/mL
-1.7
± 0.58
Week 15
Group
Value
95% CI
20 μg/mL
-1
± 0
40 μg/mL
-2
60 μg/mL
-1.5
± 2.12
80 μg/mL
-2.5
± 0.71
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this clinical trial is to learn if Compound 31543 (topical calcitriol) for treatment of hair-loss in patients with a diagnosis of breast cancer, gynecologic cancer or sarcomas receiving a taxane-based chemotherapy is safe. The main questions it aims to answer are:
* What medical problems do participants have when using compound 31543?
* How much Compound 31543 is in blood after treatment?
* How much hair is lost during treatment?
Participants will:
* Apply Compound 31543 to their scalp twice a day, starting at least 5 days before starting chemotherapy for at least 3 months or until chemotherapy treatment is completed.
* Have blood drawn on weeks 1, 5, 9, 13, and 54.
* Have photographs taken of their hair before starting and at weeks 7, 15, 27, and 54.
* Keep a diary of the condition of their hair.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BPGbio
Last refreshed: 28 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01588522.