Trial Outcomes & Findings for Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product (NCT NCT02933502)

NCT ID: NCT02933502

Last Updated: 2018-12-10

Results Overview

Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

day 28

Results posted on

2018-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	DSXS Topical Product treatment with DSXS once daily for 28 days DSXS topical product: treatment daily for 28 days
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DSXS Topical Product n=3 Participants treatment with DSXS once daily for 28 days DSXS topical product: treatment daily for 28 days
Age, Continuous	15.0 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 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	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	1 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	28.3 percent of scalp STANDARD_DEVIATION 2.9 • n=5 Participants

PRIMARY outcome

Timeframe: day 28

Population: Two patients who had normal adrenal function at baseline, used at least 21 doses of the study product, and had data from a post-treatment cortisol response test were included in the analysis. One patient was excluded from the analysis of HPA axis suppression owing to abnormal adrenal function at baseline.

Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation

Outcome measures

Outcome measures
Measure	DSXS Topical Product n=2 Participants treatment with DSXS once daily for 28 days DSXS topical product: treatment daily for 28 days
Number of Participants With HPA Axis Suppression Yes	0 Participants
Number of Participants With HPA Axis Suppression No	2 Participants

Adverse Events

DSXS Topical Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Natalie Yantovskiy

Taro Pharmaceuticals U.S.A. Inc

Phone: +1 914-345-9001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place