Trial Outcomes & Findings for Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population (NCT NCT01137032)

NCT ID: NCT01137032

Last Updated: 2016-05-04

Results Overview

The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

22 Days

Results posted on

2016-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Pandel Cream 0.1% Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pandel Cream 0.1% n=19 Participants Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=99 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants
Age, Continuous	48.3 years n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Region of Enrollment United States	19 participants n=99 Participants

PRIMARY outcome

Timeframe: 22 Days

Population: 15 subjects represents the subgroup utilized for the analysis of this endpoint.

The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.

Outcome measures

Outcome measures
Measure	Pandel Cream 0.1% n=15 Participants Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
Post-injection Serum Cortisol Level	1 participants

SECONDARY outcome

Timeframe: 22 Days

Population: 15 subjects represents the subgroup utilized for the analysis of this endpoint.

The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.

Outcome measures

Outcome measures
Measure	Pandel Cream 0.1% n=15 Participants Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
Pre-injection Serum Cortisol Levels	0 participants

SECONDARY outcome

Timeframe: 22 days

Population: 15 subjects represents the subgroup utilized for the analysis of this endpoint.

Outcome measures

Outcome measures
Measure	Pandel Cream 0.1% n=15 Participants Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.	1 participants

Adverse Events

Pandel Cream 0.1%

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pandel Cream 0.1% n=19 participants at risk Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
General disorders PYREXIA	5.3% 1/19
Infections and infestations NASOPHARYNGITIS	5.3% 1/19
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	5.3% 1/19
Musculoskeletal and connective tissue disorders ARTHRITIS	5.3% 1/19
Nervous system disorders HEADACHE	5.3% 1/19
Skin and subcutaneous tissue disorders RASH	5.3% 1/19
Skin and subcutaneous tissue disorders APPLICATION SITE IRRITATION	5.3% 1/19
Infections and infestations EAR INFECTION	5.3% 1/19
Psychiatric disorders ANXIETY	5.3% 1/19
Skin and subcutaneous tissue disorders PRURITUS	5.3% 1/19
Musculoskeletal and connective tissue disorders EXOSTOSIS	5.3% 1/19
Musculoskeletal and connective tissue disorders ARTHRALGIA	5.3% 1/19
Nervous system disorders DIZZINESS	5.3% 1/19
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	5.3% 1/19
Investigations OCCULT BLOOD	5.3% 1/19

Additional Information

Angela C. Kaplan, Associate Director Clinical Development

Fougera Pharmaceuticals Inc.

Phone: 631-659-2256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER