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

• Sponsor: Sol-Gel Technologies, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03564119
• Collaborator: (none)
• Enrollment: 372
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.6
• Patients Per Site Per Month: 32

Study Details

Study Description

Brief Summary

To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.

Condition or Disease	Intervention/Treatment	Phase
Papulopustular Rosacea	Drug: S5G4T-1; Drug: S5G4T-2	Phase 3

Detailed Description

In this Phase 3, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 372 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
• Actual Study Start Date: Jun 21, 2018
• Actual Primary Completion Date: Jun 10, 2019
• Actual Study Completion Date: Jun 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S5G4T-1 Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.	Drug: S5G4T-1; Once a day topical cream; Other Names: Encapsulated benzoyl peroxide (E-BPO) cream
Placebo Comparator: S5G4T-2 Vehicle Cream Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.	Drug: S5G4T-2; Once a day topical cream; Other Names: Vehicle cream

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12 [Baseline through Week 12]

   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.

2. Change From Baseline in Inflammatory Lesion Counts at Week 12 [Baseline, Week 12]

   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.

Secondary Outcome Measures

1. Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 [Baseline, Week 12]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.

2. Male and female 18 years of age and older.

3. Participants must have clinical diagnosis of moderate to severe rosacea.

4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.

5. Have 2 nodules or less.

Exclusion Criteria:

1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.

2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).

3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sol-Gel	Rochester	New York	United States	14623

Sponsors and Collaborators

• Sol-Gel Technologies, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 24, 2018
• Statistical Analysis Plan - May 2, 2019

More Information

Publications

None provided.

• Responsible Party: Sol-Gel Technologies, Ltd.
• ClinicalTrials.gov Identifier: NCT03564119
• Other Study ID Numbers: SGT-54-02
• First Posted: Jun 20, 2018
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sol-Gel Technologies, Ltd.: papulopustular rosacea
• Additional relevant MeSH terms: Rosacea; Benzoyl Peroxide

Study Results

Participant Flow

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

Arm/Group Title	S5G4T-1	S5G4T-2 Vehicle Cream
Arm/Group Description	Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Period Title: Overall Study
STARTED	250	122
Received at Least 1 Dose of Study Drug	249	120
COMPLETED	235	113
NOT COMPLETED	15	9

Baseline Characteristics

Arm/Group Title	S5G4T-1	S5G4T-2 Vehicle Cream	Total
Arm/Group Description	Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.	Total of all reporting groups
Overall Participants	250	122	372
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.5 (14.04)	51.5 (12.55)	50.1 (13.59)
Sex: Female, Male (Count of Participants)
Female	181 72.4%	87 71.3%	268 72%
Male	69 27.6%	35 28.7%	104 28%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	55 22%	30 24.6%	85 22.8%
Not Hispanic or Latino	195 78%	92 75.4%	287 77.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 1.6%	2 0.5%
Asian	20 8%	8 6.6%	28 7.5%
Native Hawaiian or Other Pacific Islander	3 1.2%	2 1.6%	5 1.3%
Black or African American	2 0.8%	0 0%	2 0.5%
White	220 88%	110 90.2%	330 88.7%
More than one race	5 2%	0 0%	5 1.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Baseline Inflammatory Lesion Count (Lesions) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Lesions]	29.8 (14.00)	27.5 (13.04)	29.0 (13.72)
Baseline Investigator's Global Assessment (IGA) (participants) [Number]
0 - Clear	0 0%	0 0%	0 0%
1 - Almost Clear	0 0%	0 0%	0 0%
2 - Mild	0 0%	0 0%	0 0%
3 - Moderate	227 90.8%	112 91.8%	339 91.1%
4 - Severe	23 9.2%	10 8.2%	33 8.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12
Description	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.
Time Frame	Baseline through Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	S5G4T-1	S5G4T-2 Vehicle Cream
Arm/Group Description	Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Measure Participants	250	122
Number [Percentage of Participants]	50.1 20%	25.9 21.2%

2. Primary Outcome

Title	Change From Baseline in Inflammatory Lesion Counts at Week 12
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	S5G4T-1	S5G4T-2 Vehicle Cream
Arm/Group Description	Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Measure Participants	250	122
Least Squares Mean (Standard Deviation) [Inflammatory Lesions]	-20.3 (9.64)	-13.3 (9.60)

3. Secondary Outcome

Title	Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	S5G4T-1	S5G4T-2 Vehicle Cream
Arm/Group Description	Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.	Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Measure Participants	250	122
Least Squares Mean (Standard Deviation) [Percent Change]	-69.4 (32.66)	-46.0 (32.31)

Adverse Events

Time Frame	Baseline (Day 0) through end of study (Week 12)
Adverse Event Reporting Description	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.
Arm/Group Title	S5G4T-1		S5G4T-2 Vehicle Cream
Arm/Group Description	Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.		Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
All Cause Mortality
	S5G4T-1		S5G4T-2 Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/248 (0%)		0/121 (0%)
Serious Adverse Events
	S5G4T-1		S5G4T-2 Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/248 (0.4%)		0/121 (0%)
Injury, poisoning and procedural complications
Spinal compression fracture	1/248 (0.4%)		0/121 (0%)
Other (Not Including Serious) Adverse Events
	S5G4T-1		S5G4T-2 Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/248 (5.2%)		12/121 (9.9%)
General disorders
Application site pain	6/248 (2.4%)		0/121 (0%)
Application site erythema	3/248 (1.2%)		0/121 (0%)
Application site pruritus	3/248 (1.2%)		0/121 (0%)
Infections and infestations
Nasopharyngitis	6/248 (2.4%)		3/121 (2.5%)
Sinusitis	3/248 (1.2%)		0/121 (0%)
Urinary tract infection	2/248 (0.8%)		3/121 (2.5%)
Influenza	2/248 (0.8%)		2/121 (1.7%)
Upper respiratory tract infection	2/248 (0.8%)		2/121 (1.7%)
Respiratory, thoracic and mediastinal disorders
Sinus congestion	1/248 (0.4%)		2/121 (1.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Generally, the Principal Investigator is not permitted to discuss or publish trial results without Sponsor approval.