Trial · NCT03785587
A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
NCT03785587, Phase 2, Completed, Botanix Pharmaceuticals; results first posted 2023-03-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis. Trials, record NCT03785587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03785587
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
- NCT number
- NCT03785587
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Botanix Pharmaceuticals
- Conditions
- Primary Axillary Hyperhidrosis
- Interventions
- Sofpironium Bromide Gel, 15%
- First posted
- 2018-12-24
- Last updated
- 2023-03-14
- Results first posted
- 2023-03-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With Treatment Emergent Adverse Events (All TEAEs). | Through study completion (24 weeks). | Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe. |
| Primary | The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae. | Through study completion (24 weeks). | Summary of local site tolerability by maximum severity symptom rating on a 5-point scale (0=absent, 1=minimal, 2=mild,-3=moderate, 4=severe)-Safety Population |
| Primary | The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010) | Through study completion (24 weeks). | Trough levels of sofpironium based on sampling schedule. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants With Treatment Emergent Adverse Events (All TEAEs). | Through study completion (24 weeks). | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae. | Through study completion (24 weeks). | Safety Population | participants | NUMBER |
| PRIMARY | The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010) | Through study completion (24 weeks). | PK Population | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants With Treatment Emergent Adverse Events (All TEAEs). | Gel, 15% | Mild | 5 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events (All TEAEs). | Gel, 15% | Moderate | 5 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events (All TEAEs). | Gel, 15% | Severe | 0 | Participants | |
| The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae. | Gel, 15% - MINIMAL ASSESSMENT | Burning | 1 | participants | |
| The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae. | Gel, 15% - MILD ASSESSMENT | Burning | 1 | participants | |
| The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae. | Gel, 15% - MODERATE ASSESSMENT | Burning | 2 | participants | |
| The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae. | Gel, 15% - SEVERE ASSESSMENT | Burning | 0 | participants | |
| The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae. | Gel, 15% - MINIMAL ASSESSMENT | Stinging | 1 | participants | |
| The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae. | Gel, 15% - MILD ASSESSMENT | Stinging | 1 | participants | |
| The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae. | Gel, 15% - MODERATE ASSESSMENT | Stinging | 1 | participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gel, 15% | 21 | |
| Overall Study | COMPLETED | Gel, 15% | 16 | |
| Overall Study | NOT COMPLETED | Gel, 15% | 5 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acne | Skin and subcutaneous tissue disorders | Gel, 15% | 1 | 21 | |
| other | Dermatitis Atopic | Skin and subcutaneous tissue disorders | Gel, 15% | 1 | 21 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Gel, 15% | 1 | 21 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Gel, 15% | 1 | 21 | |
| other | Rash | Skin and subcutaneous tissue disorders | Gel, 15% | 1 | 21 | |
| other | Dry Eye | Eye disorders | Gel, 15% | 1 | 21 | |
| other | Mydriasis | Eye disorders | Gel, 15% | 1 | 21 | |
| other | Vision Blurred | Eye disorders | Gel, 15% | 1 | 21 | |
| other | Chapped Lips | Gastrointestinal disorders | Gel, 15% | 1 | 21 | |
| other | Dry Mouth | Gastrointestinal disorders | Gel, 15% | 1 | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gel, 15% | 0 | 21 |
| Total, other adverse events | Gel, 15% | 7 | 21 |
| Total, serious adverse events | Gel, 15% | 0 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03785587
GET https://conductscience.org/api/trials/v1/NCT03785587/results?page=2