Trial Outcomes & Findings for RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS) (NCT NCT03445650)

Last Updated: 2023-02-09

Results Overview

Change from baseline using the Visual Index Ichthyosis Severity (VIIS) Scaling Score (0 = least, 4 = most), where a higher value represents a worse outcome, in ADX-102 treated patients

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

11 participants

Primary outcome timeframe

Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.

Results posted on

2023-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	ADX-102 1% Topical Dermal Cream ADX-102 1% Topical Dermal Cream: ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1	Vehicle Topical Dermal Cream Vehicle Topical Dermal Cream: Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1
Overall Study STARTED	7	4
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADX-102 1% Topical Dermal Cream n=7 Participants ADX-102 1% Topical Dermal Cream: ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1	Vehicle Topical Dermal Cream n=4 Participants Vehicle Topical Dermal Cream: Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1	Total n=11 Participants Total of all reporting groups
Age, Continuous	18.1 years STANDARD_DEVIATION 7.78 • n=5 Participants	9.5 years STANDARD_DEVIATION 6.35 • n=7 Participants	15.0 years STANDARD_DEVIATION 8.21 • 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	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 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 American Indian or Alaska Native	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 other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Height	150.38 centimeters STANDARD_DEVIATION 24.583 • n=5 Participants	125.68 centimeters STANDARD_DEVIATION 29.287 • n=7 Participants	141.39 centimeters STANDARD_DEVIATION 27.850 • n=5 Participants
Weight	48.81 kilograms (kg) STANDARD_DEVIATION 18.708 • n=5 Participants	29.18 kilograms (kg) STANDARD_DEVIATION 18.864 • n=7 Participants	41.67 kilograms (kg) STANDARD_DEVIATION 20.367 • n=5 Participants
Body Mass Index	20.5 kg/m^2 STANDARD_DEVIATION 3.36 • n=5 Participants	16.8 kg/m^2 STANDARD_DEVIATION 2.89 • n=7 Participants	19.1 kg/m^2 STANDARD_DEVIATION 3.57 • n=5 Participants
Body Surface Area	1.4 m^2 STANDARD_DEVIATION 0.39 • n=5 Participants	1.0 m^2 STANDARD_DEVIATION 0.42 • n=7 Participants	1.3 m^2 STANDARD_DEVIATION 0.43 • n=5 Participants

PRIMARY outcome

Timeframe: Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.

Population: modified intent to treat population

Change from baseline using the Visual Index Ichthyosis Severity (VIIS) Scaling Score (0 = least, 4 = most), where a higher value represents a worse outcome, in ADX-102 treated patients

Outcome measures

Outcome measures
Measure	ADX-102 1% Topical Dermal Cream n=6 Participants ADX-102 1% Topical Dermal Cream: ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1
Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients	-0.7 units on a scale Standard Error 0.22

Adverse Events

ADX-102 1% Topical Dermal Cream

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Vehicle Topical Dermal Cream

Serious events: 0 serious events

Other events: 2 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	ADX-102 1% Topical Dermal Cream n=7 participants at risk ADX-102 1% Topical Dermal Cream: ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1	Vehicle Topical Dermal Cream n=4 participants at risk Vehicle Topical Dermal Cream: Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1
Congenital, familial and genetic disorders Ichthyosis	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Gastrointestinal disorders Vomiting	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Investigations Eosinophil count increased	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Metabolism and nutrition disorders Iron deficiency	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Renal and urinary disorders Dysuria	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Skin and subcutaneous tissue disorders Pruritus	42.9% 3/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Skin and subcutaneous tissue disorders Dermatatitis diaper	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Skin and subcutaneous tissue disorders Dry Skin	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Infections and infestations Hordeolum	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Infections and infestations Gastroenteritis viral	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Infections and infestations Influenza	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Infections and infestations Nasopharyngitis	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Infections and infestations Pharyngitis streptococcal	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Infections and infestations Sinusitis	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Infections and infestations Upper respiratory tract infection	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
General disorders Pyrexia	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
General disorders Feeling hot	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/7 • The period of time when adverse events were collected was approximately 28 weeks.	25.0% 1/4 • The period of time when adverse events were collected was approximately 28 weeks.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	14.3% 1/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.
Blood and lymphatic system disorders Eosinophilia	28.6% 2/7 • The period of time when adverse events were collected was approximately 28 weeks.	0.00% 0/4 • The period of time when adverse events were collected was approximately 28 weeks.