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An Open Label, Safety Study to Assess the Potential for Adrenal Suppression

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Plaque Psoriasis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02932878
Enrollment
16
Registered
2016-10-13
Start date
2016-09-02
Completion date
2017-10-16
Last updated
2018-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Brief summary

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis

Detailed description

To evaluate the potential of DSXS to suppress HPA axis function in patients with mild to moderate plaque psoriasis. To evaluate the efficacy parameters and adverse event (AE) profile of DSXS administered to patients with mild to moderate plaque psoriasis.

Interventions

DRUGDSXS topical

topical treatment

Sponsors

Sun Pharmaceutical Industries, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or non pregnant, non lactating females

Exclusion criteria

* Patients under 2 years of age

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients in the Study With HPA Axis Suppression28 DaysHypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin

Countries

United States

Participant flow

Participants by arm

ArmCount
DSXS Topical Cohort 1
administered twice daily for 28 days in patients age 12-18 years of age DSXS topical: topical treatment
15
DSXS Topical Cohort 2
administered twice daily for 28 days in patients age 6-11 years or age DSXS topical: topical treatment
1
Total16

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDue to Lab Results21

Baseline characteristics

CharacteristicDSXS Topical Cohort 2DSXS Topical Cohort 1Total
Age, Continuous8.00 years15.13 years
STANDARD_DEVIATION 1.88
14.69 years
STANDARD_DEVIATION 2.55
Baseline IGA
Clear
0 Participants0 Participants0 Participants
Baseline IGA
Mild
1 Participants7 Participants8 Participants
Baseline IGA
Minimal
0 Participants0 Participants0 Participants
Baseline IGA
Moderate
0 Participants8 Participants8 Participants
Baseline IGA
Severe
0 Participants0 Participants0 Participants
Baseline Total BSA1.31 meters squared1.86 meters squared
STANDARD_DEVIATION 0.35
1.83 meters squared
STANDARD_DEVIATION 0.37
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants11 Participants12 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants4 Participants4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1 Participants13 Participants14 Participants
Sex: Female, Male
Female
1 Participants4 Participants5 Participants
Sex: Female, Male
Male
0 Participants11 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 1
other
Total, other adverse events
0 / 150 / 1
serious
Total, serious adverse events
0 / 150 / 1

Outcome results

Primary

Proportion of Patients in the Study With HPA Axis Suppression

Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin

Time frame: 28 Days

Population: The one patient in Cohort 2 did not qualify for evaluation of HPA axis suppression.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
DSXS Topical Cohort 1Proportion of Patients in the Study With HPA Axis SuppressionYes1 Participants
DSXS Topical Cohort 1Proportion of Patients in the Study With HPA Axis SuppressionNo10 Participants
DSXS Topical Cohort 2Proportion of Patients in the Study With HPA Axis SuppressionYes0 Participants
DSXS Topical Cohort 2Proportion of Patients in the Study With HPA Axis SuppressionNo0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026