Trial Outcomes & Findings for Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia (NCT NCT05802173)
NCT ID: NCT05802173
Last Updated: 2025-11-12
Results Overview
Collection of non-vellus target area hair count results at week 16
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
16 weeks
Results posted on
2025-11-12
Participant Flow
71 participants randomized in the study and were evaluable for safety analyses.
Participant milestones
| Measure |
TDM-105795 Topical Solution, 0.0025%
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
23
|
22
|
|
Overall Study
COMPLETED
|
23
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
4
|
Reasons for withdrawal
| Measure |
TDM-105795 Topical Solution, 0.0025%
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
6
|
4
|
|
Overall Study
non-compliance
|
0
|
1
|
0
|
Baseline Characteristics
Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia
Baseline characteristics by cohort
| Measure |
TDM-105795 Topical Solution, 0.0025%
n=26 Participants
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
n=23 Participants
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
n=22 Participants
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 8.84 • n=10 Participants
|
40.7 years
STANDARD_DEVIATION 9.73 • n=10 Participants
|
40.8 years
STANDARD_DEVIATION 9.38 • n=20 Participants
|
40.9 years
STANDARD_DEVIATION 9.17 • n=45 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=10 Participants
|
23 Participants
n=10 Participants
|
22 Participants
n=20 Participants
|
71 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=10 Participants
|
23 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
65 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
11 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=10 Participants
|
15 Participants
n=10 Participants
|
15 Participants
n=20 Participants
|
54 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: 16 weeksCollection of non-vellus target area hair count results at week 16
Outcome measures
| Measure |
TDM-105795 Topical Solution, 0.0025%
n=26 Participants
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
n=23 Participants
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
n=22 Participants
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Non-vellus Target Area Hair Count (TAHC)
|
20.3 hair count
Standard Deviation 29.40
|
22.4 hair count
Standard Deviation 18.59
|
14.0 hair count
Standard Deviation 17.59
|
PRIMARY outcome
Timeframe: 16 weeksCollection of hair growth assessment (HGA) questionnaire at week 16. Scalp hair growth will be compared from Baseline using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3).
Outcome measures
| Measure |
TDM-105795 Topical Solution, 0.0025%
n=26 Participants
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
n=23 Participants
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
n=22 Participants
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Evaluation of Treatment Benefit
Slightly to moderately decreased
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Evaluation of Treatment Benefit
No change
|
10 Participants
|
5 Participants
|
9 Participants
|
|
Evaluation of Treatment Benefit
Slightly to moderately increased
|
9 Participants
|
8 Participants
|
8 Participants
|
|
Evaluation of Treatment Benefit
Missing
|
3 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 16 weeksCollection of non-vellus target area hair width results at week 16
Outcome measures
| Measure |
TDM-105795 Topical Solution, 0.0025%
n=21 Participants
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
n=13 Participants
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
n=15 Participants
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Change in Non-vellus Target Area Hair Width (TAHW)
|
-1.27 microns
Standard Deviation 2.30
|
-2.18 microns
Standard Deviation 2.00
|
-1.27 microns
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: 16 weeksNon-vellus Target Area Hair Darkness (TAHD) results at week 16. Scale is a gray scale, 0(white) to 255(black) measured in a 1 cm2 area. Positive mean change is a better outcome.
Outcome measures
| Measure |
TDM-105795 Topical Solution, 0.0025%
n=21 Participants
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
n=13 Participants
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
n=15 Participants
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Change in Non-vellus Target Area Hair Darkness (TAHD)
|
4.6 score on a scale
Standard Deviation 12.27
|
3.2 score on a scale
Standard Deviation 15.52
|
-3.6 score on a scale
Standard Deviation 14.33
|
SECONDARY outcome
Timeframe: 16 weeksSubject's evaluation of treatment benefit via the hair growth index (HGI) questionnaire at week 16. Scalp hair growth will be compared from Baseline using the following 7-point scale: much less (-3), moderately less (-2), slightly less (-1), the same amount (0), slightly more (1), moderately more (2), and much more (3).
Outcome measures
| Measure |
TDM-105795 Topical Solution, 0.0025%
n=26 Participants
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
n=23 Participants
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
n=22 Participants
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Hair Growth Index (HGI) Questionnaire
Slightly to moderately more scalp
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Hair Growth Index (HGI) Questionnaire
Missing
|
3 Participants
|
7 Participants
|
4 Participants
|
|
Hair Growth Index (HGI) Questionnaire
Slightly to moderately less scalp
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Hair Growth Index (HGI) Questionnaire
Same amount
|
10 Participants
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 16 weeksCollection of IGA grade at week 16. The Canfield Review application will be used. The evaluator will assess the subject's scalp hair growth using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3).
Outcome measures
| Measure |
TDM-105795 Topical Solution, 0.0025%
n=26 Participants
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
n=23 Participants
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
n=22 Participants
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Evaluation of Investigator's Global Assessment (IGA) Grade
slightly to moderately decreased
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Evaluation of Investigator's Global Assessment (IGA) Grade
No change
|
9 Participants
|
5 Participants
|
12 Participants
|
|
Evaluation of Investigator's Global Assessment (IGA) Grade
slightly to moderately increased
|
13 Participants
|
8 Participants
|
6 Participants
|
|
Evaluation of Investigator's Global Assessment (IGA) Grade
Missing
|
3 Participants
|
7 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 20 weeksCollection of adverse events
Outcome measures
| Measure |
TDM-105795 Topical Solution, 0.0025%
n=26 Participants
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
n=23 Participants
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
n=22 Participants
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Number of Participants With Any Local and Systemic Adverse Events (AEs)
Subjects with any TEAE
|
8 participants
|
6 participants
|
7 participants
|
|
Number of Participants With Any Local and Systemic Adverse Events (AEs)
Subjects with any treatment related TEAE
|
1 participants
|
5 participants
|
1 participants
|
|
Number of Participants With Any Local and Systemic Adverse Events (AEs)
Subjects with any serious TEAE
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksCollection of local skin reactions at day 1, week 2, week 4, week 8, week 12, and week 16
Outcome measures
| Measure |
TDM-105795 Topical Solution, 0.0025%
n=26 Participants
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
n=23 Participants
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
n=22 Participants
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Number of Subjects With Presence (and Severity) of Local Skin Reactions (LSRs)
Erythema
|
10 participants
|
10 participants
|
2 participants
|
|
Number of Subjects With Presence (and Severity) of Local Skin Reactions (LSRs)
Edema
|
3 participants
|
1 participants
|
2 participants
|
|
Number of Subjects With Presence (and Severity) of Local Skin Reactions (LSRs)
Erosion
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Subjects With Presence (and Severity) of Local Skin Reactions (LSRs)
Scaling
|
1 participants
|
4 participants
|
0 participants
|
|
Number of Subjects With Presence (and Severity) of Local Skin Reactions (LSRs)
Pruritus
|
1 participants
|
5 participants
|
2 participants
|
|
Number of Subjects With Presence (and Severity) of Local Skin Reactions (LSRs)
Burning/Stingling
|
3 participants
|
3 participants
|
0 participants
|
Adverse Events
TDM-105795 Topical Solution, 0.0025%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
TDM-105795 Topical Solution, 0.02%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TDM-105795 Topical Vehicle Solution
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TDM-105795 Topical Solution, 0.0025%
n=26 participants at risk
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Solution, 0.02%
n=23 participants at risk
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%: The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
TDM-105795 Topical Vehicle Solution
n=22 participants at risk
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution: The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/26 • 16 weeks
|
4.3%
1/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/26 • 16 weeks
|
4.3%
1/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
|
Investigations
Blood cholesterol increased
|
3.8%
1/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Investigations
Blood creatinine increased
|
3.8%
1/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
|
Nervous system disorders
Nerve compression
|
3.8%
1/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
3.8%
1/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/26 • 16 weeks
|
4.3%
1/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
|
Vascular disorders
Hypertension
|
3.8%
1/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
|
Infections and infestations
Application site folliculitis
|
0.00%
0/26 • 16 weeks
|
8.7%
2/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/26 • 16 weeks
|
4.3%
1/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
|
General disorders
Application site erythema
|
0.00%
0/26 • 16 weeks
|
4.3%
1/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
General disorders
Application site irritation
|
3.8%
1/26 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
General disorders
Application site pain
|
0.00%
0/26 • 16 weeks
|
4.3%
1/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
General disorders
Application site pruritus
|
3.8%
1/26 • 16 weeks
|
8.7%
2/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
|
General disorders
Fatigue
|
0.00%
0/26 • 16 weeks
|
4.3%
1/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
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Additional Information
Arthur P. Bertolino MD, PhD, MBA Chief Medical Officer
Technoderma Medicines
Phone: +1.616.928.1145
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator and all employees and coworkers involved with this study shall not disclose or use for any purpose other than performance of the study, any data, records, or other unpublished, confidential information disclosed to those individuals for the purpose of the study. Prior written agreement from TI or the Sponsor must be obtained for the disclosure of any said confidential information to other parties.
- Publication restrictions are in place
Restriction type: OTHER