Trial Outcomes & Findings for A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS) (NCT NCT02402309)

NCT ID: NCT02402309

Last Updated: 2022-12-13

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

The safety assessment period is approximately 9 weeks.

Results posted on

2022-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Topical NS2 1% Dermatologic Cream NS2 1% topical cream for dermal application Active topical NS2 1% dermatologic cream	Topical Vehicle Dermatologic Vehicle placebo for dermal application Vehicle placebo 0.0% NS2 dermatologic cream
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical NS2 1% Dermatologic Cream n=6 Participants NS2 1% topical cream for dermal application Active topical NS2 1% dermatologic cream	Topical Vehicle Dermatologic n=6 Participants Vehicle placebo for dermal application Vehicle placebo 0.0% NS2 dermatologic cream	Total n=12 Participants Total of all reporting groups
Age, Continuous	14.2 years STANDARD_DEVIATION 5.08 • n=5 Participants	17.3 years STANDARD_DEVIATION 5.01 • n=7 Participants	15.8 years STANDARD_DEVIATION 5.08 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Height	150.0 centimeters STANDARD_DEVIATION 19.71 • n=5 Participants	157.2 centimeters STANDARD_DEVIATION 9.14 • n=7 Participants	153.6 centimeters STANDARD_DEVIATION 15.13 • n=5 Participants
Weight	41.4 kilograms STANDARD_DEVIATION 13.07 • n=5 Participants	59.8 kilograms STANDARD_DEVIATION 14.36 • n=7 Participants	50.6 kilograms STANDARD_DEVIATION 16.24 • n=5 Participants
Body Surface Area	1.54 Mosteller Method (m2) STANDARD_DEVIATION 0.527 • n=5 Participants	1.95 Mosteller Method (m2) STANDARD_DEVIATION 0.890 • n=7 Participants	1.77 Mosteller Method (m2) STANDARD_DEVIATION 0.743 • n=5 Participants

PRIMARY outcome

Timeframe: The safety assessment period is approximately 9 weeks.

Outcome measures

Outcome measures
Measure	Topical NS2 1% Dermatologic Cream n=6 Participants NS2 1% topical cream for dermal application Active topical NS2 1% dermatologic cream	Topical Vehicle Dermatologic n=6 Participants Vehicle placebo for dermal application Vehicle placebo 0.0% NS2 dermatologic cream
Number of Participants Experiencing a Serious Adverse Event (SAE).	0 Participants	0 Participants

PRIMARY outcome

Timeframe: The safety assessment period is approximately 9 weeks.

Outcome measures

Outcome measures
Measure	Topical NS2 1% Dermatologic Cream n=6 Participants NS2 1% topical cream for dermal application Active topical NS2 1% dermatologic cream	Topical Vehicle Dermatologic n=6 Participants Vehicle placebo for dermal application Vehicle placebo 0.0% NS2 dermatologic cream
Number of Participants Experiencing an Adverse Event Leading to Discontinuation.	0 Participants	0 Participants

Adverse Events

Topical NS2 1% Dermatologic Cream

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Topical Vehicle Dermatologic

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Sr. Director, Clinical Operations

Aldeyra Therapeutics, Inc.

Phone: 781-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Topical NS2 1% Dermatologic Cream n=6 participants at risk NS2 1% topical cream for dermal application Active topical NS2 1% dermatologic cream	Topical Vehicle Dermatologic n=6 participants at risk Vehicle placebo for dermal application Vehicle placebo 0.0% NS2 dermatologic cream
Skin and subcutaneous tissue disorders Pruritus	33.3% 2/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Skin and subcutaneous tissue disorders Blister	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Infections and infestations Tooth abscess	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Gastrointestinal disorders Constipation	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Gastrointestinal disorders Diarrhea	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Nervous system disorders Headache	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Nervous system disorders Lethargy	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
General disorders Pyrexia	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Immune system disorders Seasonal allergy	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Renal and urinary disorders Urine abnormality	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.	0.00% 0/6 • Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.