Trial Outcomes & Findings for A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea (NCT NCT03564119)

Last Updated: 2021-12-15

Results Overview

Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)". Please note, the Percentage of Participants multiplied by the Overall Number of Participants Analyzed does not equal a whole number because missing efficacy data was based on estimation using the method of Markov Chain Monte Carlo (MCMC) imputation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

372 participants

Primary outcome timeframe

Baseline through Week 12

Results posted on

2021-12-15

Participant Flow

Participants were randomized to receive either S5G4T-1 (Encapsulated Benzoyl Peroxide \[E-BPO\] cream) or vehicle in a 2:1 ratio.

Participant milestones

Participant milestones
Measure	S5G4T-1 Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	S5G4T-2 Vehicle Cream Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Overall Study STARTED	250	122
Overall Study Received at Least 1 Dose of Study Drug	249	120
Overall Study COMPLETED	235	113
Overall Study NOT COMPLETED	15	9

Reasons for withdrawal

Reasons for withdrawal
Measure	S5G4T-1 Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	S5G4T-2 Vehicle Cream Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Overall Study Adverse Event	4	0
Overall Study Lost to Follow-up	1	4
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	9	4
Overall Study Other Than Specified	0	1

Baseline Characteristics

A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	S5G4T-1 n=250 Participants Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	S5G4T-2 Vehicle Cream n=122 Participants Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.	Total n=372 Participants Total of all reporting groups
Age, Continuous	49.5 Years STANDARD_DEVIATION 14.04 • n=5 Participants	51.5 Years STANDARD_DEVIATION 12.55 • n=7 Participants	50.1 Years STANDARD_DEVIATION 13.59 • n=5 Participants
Sex: Female, Male Female	181 Participants n=5 Participants	87 Participants n=7 Participants	268 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	35 Participants n=7 Participants	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	55 Participants n=5 Participants	30 Participants n=7 Participants	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	195 Participants n=5 Participants	92 Participants n=7 Participants	287 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants	8 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	220 Participants n=5 Participants	110 Participants n=7 Participants	330 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Inflammatory Lesion Count	29.8 Lesions STANDARD_DEVIATION 14.00 • n=5 Participants	27.5 Lesions STANDARD_DEVIATION 13.04 • n=7 Participants	29.0 Lesions STANDARD_DEVIATION 13.72 • n=5 Participants
Baseline Investigator's Global Assessment (IGA) 0 - Clear	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Baseline Investigator's Global Assessment (IGA) 1 - Almost Clear	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Baseline Investigator's Global Assessment (IGA) 2 - Mild	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Baseline Investigator's Global Assessment (IGA) 3 - Moderate	227 participants n=5 Participants	112 participants n=7 Participants	339 participants n=5 Participants
Baseline Investigator's Global Assessment (IGA) 4 - Severe	23 participants n=5 Participants	10 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through Week 12

Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.

Outcome measures

Outcome measures
Measure	S5G4T-1 n=250 Participants Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	S5G4T-2 Vehicle Cream n=122 Participants Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12	50.1 Percentage of Participants	25.9 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.

Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment, analysis center and treatment by analysis center interaction and the Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

Outcome measures

Outcome measures
Measure	S5G4T-1 n=250 Participants Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	S5G4T-2 Vehicle Cream n=122 Participants Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Change From Baseline in Inflammatory Lesion Counts at Week 12	-20.3 Inflammatory Lesions Standard Deviation 9.64	-13.3 Inflammatory Lesions Standard Deviation 9.60

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.

Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an ANCOVA with factors of treatment and analysis center and Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

Outcome measures

Outcome measures
Measure	S5G4T-1 n=250 Participants Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	S5G4T-2 Vehicle Cream n=122 Participants Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12	-69.4 Percent Change Standard Deviation 32.66	-46.0 Percent Change Standard Deviation 32.31

Adverse Events

S5G4T-1

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

S5G4T-2 Vehicle Cream

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	S5G4T-1 n=248 participants at risk Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	S5G4T-2 Vehicle Cream n=121 participants at risk Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Injury, poisoning and procedural complications Spinal compression fracture	0.40% 1/248 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.	0.00% 0/121 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.

Other adverse events

Other adverse events
Measure	S5G4T-1 n=248 participants at risk Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	S5G4T-2 Vehicle Cream n=121 participants at risk Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Infections and infestations Nasopharyngitis	2.4% 6/248 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.	2.5% 3/121 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.
Infections and infestations Sinusitis	1.2% 3/248 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.	0.00% 0/121 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.
Infections and infestations Urinary tract infection	0.81% 2/248 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.	2.5% 3/121 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.
Infections and infestations Influenza	0.81% 2/248 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.	1.7% 2/121 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.
Infections and infestations Upper respiratory tract infection	0.81% 2/248 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.	1.7% 2/121 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.
General disorders Application site pain	2.4% 6/248 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.	0.00% 0/121 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.
General disorders Application site erythema	1.2% 3/248 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.	0.00% 0/121 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.
General disorders Application site pruritus	1.2% 3/248 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.	0.00% 0/121 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.40% 1/248 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.	1.7% 2/121 • Baseline (Day 0) through end of study (Week 12) Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.

Additional Information

Sol-Gel

Sol-Gel Technologies, Ltd.

Phone: 972-8-9313433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Generally, the Principal Investigator is not permitted to discuss or publish trial results without Sponsor approval.
Publication restrictions are in place

Restriction type: OTHER