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A Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02886494
Recruitment Status : Completed
First Posted : September 1, 2016
Results First Posted : July 19, 2021
Last Update Posted : October 13, 2022
Sponsor:
Information provided by (Responsible Party):
Charsire Biotechnology Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Alzheimer's Disease or Vascular Dementia
Interventions Drug: BAC treatment
Drug: Matched vehicle
Enrollment 80
Recruitment Details Recruitment was conducted in the United States. The study was open for recruitment in December 2016 and the first participant was successfully enrolled in January 2017.
Pre-assignment Details The planned sample size was determined to be 45 versus 15 patients (3:1 ratio) for BAC treatment versus vehicle groups, 60 evaluable patients in total. To ensure the completion of 60 evaluable patients, around 75 patients were planned to be recruited. Actually, in this study, 80 eligible subjects were recruited and 59 evaluable subjects were achieved.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description

BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks.

Subjects were randomized 3:1 to receive double blind treatment of BAC or matched vehicle

 BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Period Title: Overall Study
Started 60 20
Completed 43 16
Not Completed 17 4
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             12             3
Protocol Violation             4             1
Arm/Group Title BAC Treatment Matched Vehicle Total
Hide Arm/Group Description

BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks.

Subjects were randomized 3:1 to receive double blind treatment of BAC or matched vehicle

 BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 60 20 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 20 participants 80 participants
73.2  (9.65) 73.1  (9.19) 73.2  (9.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 20 participants 80 participants
Female
41
  68.3%
11
  55.0%
52
  65.0%
Male
19
  31.7%
9
  45.0%
28
  35.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 60 participants 20 participants 80 participants
Africa Americans
5
   8.3%
2
  10.0%
7
   8.8%
Caucasians
54
  90.0%
17
  85.0%
71
  88.8%
Hispanic
1
   1.7%
0
   0.0%
1
   1.3%
Hispanic Native American
0
   0.0%
1
   5.0%
1
   1.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 60 participants 20 participants 80 participants
60
 100.0%
20
 100.0%
80
 100.0%
Dementia history  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 20 participants 80 participants
Alzheimer's Disease
42
  70.0%
13
  65.0%
55
  68.8%
Mixed Dementia
11
  18.3%
6
  30.0%
17
  21.3%
Vascular Dementia
7
  11.7%
1
   5.0%
8
  10.0%
1.Primary Outcome
Title Change in Alzheimer Disease Assessment Scale-cognitive (ADAS-cog) Score at Week 12 Visit Compared to Baseline
Hide Description The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. It consists of 11 parts: 1. Word Recall Task; 2. Naming Task; 3: Commands; 4: Constructional Praxis; 5. Ideational Praxis; 6. Orientation; 7. Word Recognition Task; 8. Language; 9. Comprehension of Spoken Language; 10. Word Finding Difficulty; and 11. Remembering Test Instructions. Scores range from 0 to 70 with lower scores indicating lesser severity. ADAS-Cog was measured at Screening, Randomization/Baseline, Week 4, Week 8 and Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 44 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.05  (5.726) -2.25  (4.973)
2.Secondary Outcome
Title Change in ADAS-cog Score at All Post Treatment Visits (Except Week 12 Visit) Compared to Baseline
Hide Description The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. It consists of 11 parts: 1. Word Recall Task; 2. Naming Task; 3: Commands; 4: Constructional Praxis; 5. Ideational Praxis; 6. Orientation; 7. Word Recognition Task; 8. Language; 9. Comprehension of Spoken Language; 10. Word Finding Difficulty; and 11. Remembering Test Instructions. Scores range from 0 to 70 with lower scores indicating lesser severity. ADAS-Cog was measured at Screening, Randomization/Baseline, Week 4, Week 8 and Week 12.
Time Frame Week 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Arm BAC Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 - Baseline Number Analyzed 51 participants 18 participants
-0.51  (4.096) -2.33  (4.393)
Week 8 - Baseline Number Analyzed 48 participants 17 participants
-0.79  (4.177) -2.06  (5.068)
3.Secondary Outcome
Title Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Hide Description This is a global measure of detectable change in cognition, function and behavior. The format for CIBIS/CIBIC-Plus consists of the assessment of an independent clinician based on observation of the patient at an interview, and information provided by the caregiver. The clinician's assessing severity at baseline and overall impression for assessing severity of the global change in disease severity, compared with baseline, is rated. The CIBIS/CIBIC plus examined general, cognitive, and behavioral function and activities of daily living on a 7-point categorical rating scale, ranging from a score of 0 indicating "Not assessed", to a score of 7 indicating "Among the most extremely ill patients" for CIBIS and ranging from 1 indicating "Very much improved", to a score of 7 indicating "Marked worsening", and with a score of 4 indicating "no change" for CIBIC-Plus. CIBIS was measured at Randomization visit and CIBIC-Plus was measured at Week 4, Week 8, and Week 12.
Time Frame Week 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 51 participants 18 participants
1. Very much improved
0
   0.0%
0
   0.0%
2. Much improved
1
   2.0%
1
   5.6%
3. Minimal improved
6
  11.8%
3
  16.7%
4. No change
41
  80.4%
10
  55.6%
5. Minimal worsening
3
   5.9%
4
  22.2%
6. Moderate worsening
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 48 participants 17 participants
1. Very much improved
0
   0.0%
0
   0.0%
2. Much improved
1
   2.1%
1
   5.9%
3. Minimal improved
2
   4.2%
1
   5.9%
4. No change
36
  75.0%
13
  76.5%
5. Minimal worsening
8
  16.7%
2
  11.8%
6. Moderate worsening
1
   2.1%
0
   0.0%
Week 12 Number Analyzed 44 participants 16 participants
1. Very much improved
1
   2.3%
0
   0.0%
2. Much improved
1
   2.3%
2
  12.5%
3. Minimal improved
2
   4.5%
0
   0.0%
4. No change
33
  75.0%
11
  68.8%
5. Minimal worsening
5
  11.4%
3
  18.8%
6. Moderate worsening
2
   4.5%
0
   0.0%
4.Secondary Outcome
Title Change in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Score at All Post Treatment Visits Compared to Baseline
Hide Description An inventory of informant based items to assess activities of daily living and instrumental activities of daily living, i.e. functional performance, of Alzheimer's disease (AD). It consists of 23-item inventory of ADL, rated based on extent of assistance the patient requires (independently, with supervision, with physical help): 0 (total independence in performing an activity) to 4 (total inability to act independently). Each question varies in the number of options to choose. Total score range: 0 to 78; higher scores indicate less functional impairment. ADL will be measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame Week 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 - Baseline Number Analyzed 51 participants 18 participants
-0.71  (3.613) 1.17  (4.618)
Week 8 - Baseline Number Analyzed 48 participants 17 participants
0.08  (3.188) 0.53  (6.084)
Week 12 - Baseline Number Analyzed 44 participants 16 participants
0.23  (3.241) 1.75  (5.422)
5.Secondary Outcome
Title Change in Mini-Mental State Examination (MMSE) Score at All Post Treatment Visits Compared to Baseline
Hide Description This is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial abilities and language. The score ranges from 0 to 30, with higher scores indicating better cognitive function. MMSE was measured at Screening, Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame Week 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 - Baseline Number Analyzed 51 participants 18 participants
0.61  (2.089) 0.17  (2.431)
Week 8 - Baseline Number Analyzed 48 participants 17 participants
0.25  (1.732) 1.35  (2.691)
Week 12 - Baseline Number Analyzed 44 participants 16 participants
0.43  (2.182) 0.56  (2.476)
6.Secondary Outcome
Title Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Frequency × Severity
Hide Description The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 10 behavioral domains (10-item NPI, section A~J) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. Frequency is scored from 1 (occasionally) to 4 (very frequently) and severity is rated from 1 (mild) to 3 (severe). The score for each domain is frequency multiplied by severity. Therefore, the score ranges from 1 to 12 with higher scores indicate worse condition. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame Week 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 - Baseline Number Analyzed 51 participants 18 participants
-0.37  (8.607) -2.28  (6.952)
Week 8 - Baseline Number Analyzed 48 participants 17 participants
-0.75  (4.024) -2.76  (6.250)
Week 12 - Baseline Number Analyzed 44 participants 16 participants
-1.48  (6.550) -3.13  (6.672)
7.Secondary Outcome
Title Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Caregiver Distress Score
Hide Description The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 10 behavioral domains (10-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. NPI-10 Caregiver Distress score is scored for associated caregiver distress from 0 (no distress) to 5 (very severe or extreme). Higher scores indicate greater distress. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame Week 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 - Baseline Number Analyzed 51 participants 18 participants
-0.02  (2.839) -1.94  (4.094)
Week 8 - Baseline Number Analyzed 48 participants 17 participants
-0.52  (1.902) -2.06  (4.451)
Week 12 - Baseline Number Analyzed 44 participants 16 participants
-0.91  (2.595) -2.25  (4.740)
8.Secondary Outcome
Title Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Frequency × Severity Score
Hide Description The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 12 behavioral domains (12-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. Frequency is scored from 1 (occasionally) to 4 (very frequently) and severity is rated from 1 (mild) to 3 (severe). The score for each domain is frequency multiplied by severity. Therefore, the score ranges from 1 to 12 with higher scores indicate worse condition. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame Week 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 - Baseline Number Analyzed 51 participants 18 participants
-0.61  (9.944) -3.89  (9.074)
Week 8 - Baseline Number Analyzed 48 participants 17 participants
-1.29  (6.348) -4.76  (9.437)
Week 12 - Baseline Number Analyzed 44 participants 16 participants
-1.80  (8.582) -5.50  (10.047)
9.Secondary Outcome
Title Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Caregiver Distress Score
Hide Description The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 12 behavioral domains (12-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. NPI-12 Caregiver Distress score is scored for associated caregiver distress from 0 (no distress) to 5 (very severe or extreme). Higher scores indicate greater distress. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame Week 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 - Baseline Number Analyzed 51 participants 18 participants
-0.02  (3.010) -2.56  (5.193)
Week 8 - Baseline Number Analyzed 48 participants 17 participants
-0.67  (2.291) -2.76  (5.815)
Week 12 - Baseline Number Analyzed 44 participants 16 participants
-0.93  (2.840) -3.13  (6.174)
10.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication. Laboratory abnormalities should not be recorded as AEs unless determined to be clinically significant by the Investigator. The number of participants with adverse events within the BAC and placebo groups was determined.
Time Frame AEs were reported through the study completion (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Measure Type: Count of Participants
Unit of Measure: Participants
20
  33.3%
7
  35.0%
11.Post-Hoc Outcome
Title "Responder" Analysis of MMSE Score at All Post Treatment Visits Compared to Baseline, on All Subjects Not Receiving Any Dementia Medication (Naïve)
Hide Description

This is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial abilities and language. The maximum score is 30, with higher scores indicating better cognitive function. ).

"Responder" analysis consist of two steps. (1) The baseline MMSE score is deducted from the post-treatment visit MMSE score; (2) the minus baseline score in step 1 is being dichotomized into two binary variable of either "responder" or "non-responder". Patients who make progress or remain unchanged on the cognitive test compared to baseline are considered as "responders", whereas patients who have deterioration on the cognitive test compared to baseline are considered as "non-responders".
Time Frame Week 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 - baseline Number Analyzed 17 participants 8 participants
13
  76.5%
5
  62.5%
Week 8 - baseline Number Analyzed 15 participants 8 participants
12
  80.0%
6
  75.0%
Week 12 - baseline Number Analyzed 14 participants 7 participants
12
  85.7%
5
  71.4%
12.Post-Hoc Outcome
Title "Responder" Analysis of ADAS-cog Score at All Post Treatment Visits Compared to Baseline, on All Subjects Not Receiving Any Dementia Medication (Naïve)
Hide Description

The ADAS-Cog Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. Scores range from 0 to 70 with lower scores indicating lesser severity.

"Responder" analysis consist of two steps. (1) The baseline ADAS-cog score score is deducted from the post-treatment visit ADAS-cog score; (2) the minus baseline score in step 1 is being dichotomized into two binary variable of either "responder" or "non-responder". Patients who make progress or remain unchanged on the cognitive test are considered as "responders", whereas patients who have deterioration on the cognitive test are considered as "non-responders".
Time Frame Week 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who have received at least one dose of study medication.
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description:
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
Overall Number of Participants Analyzed 60 20
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 - Baseline Number Analyzed 17 participants 8 participants
13
  76.5%
7
  87.5%
Week 8 - Baseline Number Analyzed 15 participants 8 participants
10
  66.7%
6
  75.0%
Week 12 - Baseline Number Analyzed 14 participants 7 participants
11
  78.6%
4
  57.1%
Time Frame AE data was collected from Screening visit to Final visit (up to 12 weeks)
Adverse Event Reporting Description All enrolled subjects were used for the analysis of AE and SAE.
 
Arm/Group Title BAC Treatment Matched Vehicle
Hide Arm/Group Description BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
All-Cause Mortality
BAC Treatment Matched Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
BAC Treatment Matched Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BAC Treatment Matched Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   6/60 (10.00%)   7/20 (35.00%) 
Infections and infestations     
Nasopharyngitis * 1  2/60 (3.33%)  1/20 (5.00%) 
Injury, poisoning and procedural complications     
Fall * 1  0/60 (0.00%)  1/20 (5.00%) 
Injury * 1  0/60 (0.00%)  1/20 (5.00%) 
Muscle strain * 1  0/60 (0.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/60 (0.00%)  1/20 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  1/60 (1.67%)  1/20 (5.00%) 
Nervous system disorders     
Dizziness * 1  1/60 (1.67%)  1/20 (5.00%) 
Headache * 1  3/60 (5.00%)  2/20 (10.00%) 
Somnolence * 1  0/60 (0.00%)  2/20 (10.00%) 
Skin and subcutaneous tissue disorders     
Erythema * 1  0/60 (0.00%)  1/20 (5.00%) 
Hair growth abnormal * 1  0/60 (0.00%)  1/20 (5.00%) 
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: R&D associate
Organization: Charsire Biotechnology Corp.
Phone: +886-6-702-0817
EMail: cs42@charsire.com
Layout table for additonal information
Responsible Party: Charsire Biotechnology Corp.
ClinicalTrials.gov Identifier: NCT02886494    
Other Study ID Numbers: BAC-02
First Submitted: August 29, 2016
First Posted: September 1, 2016
Results First Submitted: May 18, 2021
Results First Posted: July 19, 2021
Last Update Posted: October 13, 2022