Trial Outcomes & Findings for Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS (NCT NCT02933528)

NCT ID: NCT02933528

Last Updated: 2018-12-06

Results Overview

Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2018-12-06

Participant Flow

Participant milestones

Measure	Dsxs Topical Product treatment with DSXS once daily for 28 days DSXS Topical product: once daily for 28 days
Overall Study STARTED	24
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Dsxs Topical Product treatment with DSXS once daily for 28 days DSXS Topical product: once daily for 28 days
Overall Study Lost to Follow-up	2

Baseline Characteristics

Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS

Baseline characteristics by cohort

Measure	Dsxs Topical Product n=23 Participants treatment with DSXS once daily for 28 days DSXS Topical product: once daily for 28 days
Age, Continuous	48.8 years STANDARD_DEVIATION 17.9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Percent Scalp Affected with Plaque Psoriasis	42.2 percent of scalp STANDARD_DEVIATION 22.6 • n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation

Outcome measures

Measure	Dsxs Topical Product n=14 Participants treatment with DSXS once daily for 28 days DSXS Topical product: once daily for 28 days
Proportion of Patients in the Study With HPA Axis Suppression Yes	1 Participants
Proportion of Patients in the Study With HPA Axis Suppression No	13 Participants

Adverse Events

Dsxs Topical Product

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dsxs Topical Product n=23 participants at risk treatment with DSXS once daily for 28 days DSXS Topical product: once daily for 28 days
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	4.3% 1/23 • Number of events 1 • 1 year, 1 month

Other adverse events

Measure	Dsxs Topical Product n=23 participants at risk treatment with DSXS once daily for 28 days DSXS Topical product: once daily for 28 days
Eye disorders Conjunctival haemorrhage	4.3% 1/23 • Number of events 1 • 1 year, 1 month
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • Number of events 1 • 1 year, 1 month
Gastrointestinal disorders Nausea	4.3% 1/23 • Number of events 1 • 1 year, 1 month
Gastrointestinal disorders Vomiting	4.3% 1/23 • Number of events 1 • 1 year, 1 month
General disorders Application site alopecia	4.3% 1/23 • Number of events 1 • 1 year, 1 month
General disorders Chest pain	4.3% 1/23 • Number of events 1 • 1 year, 1 month
Injury, poisoning and procedural complications Chemical burn of skin	4.3% 1/23 • Number of events 1 • 1 year, 1 month
Nervous system disorders Headache	4.3% 1/23 • Number of events 1 • 1 year, 1 month
Nervous system disorders Sinus headache	4.3% 1/23 • Number of events 1 • 1 year, 1 month
Pregnancy, puerperium and perinatal conditions Pregnancy	4.3% 1/23 • Number of events 1 • 1 year, 1 month
Reproductive system and breast disorders Dysmenorrhoea	4.3% 1/23 • Number of events 1 • 1 year, 1 month
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • Number of events 1 • 1 year, 1 month
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.7% 2/23 • Number of events 2 • 1 year, 1 month
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	4.3% 1/23 • Number of events 2 • 1 year, 1 month
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.3% 1/23 • Number of events 1 • 1 year, 1 month

Additional Information

Natalie Yantovskiy

Taro Pharmaceuticals U.S.A. Inc

Phone: +1 914-345-9001

Email: Natalie.Yantovskiy@Taro.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place