A Study of S6G5T-3 in the Treatment of Acne Vulgaris

• Sponsor: Sol-Gel Technologies, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03761784
• Collaborator: (none)
• Enrollment: 424
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.3
• Patients Per Site Per Month: 34.4

Study Details

Study Description

Brief Summary

To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: S6G5T-3; Drug: S6G5T-8	Phase 3

Detailed Description

In this Phase 3, multi-center, 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 9 years of age with facial acne vulgaris will be eligible for enrollment for daily treatment with S6G5T-3 or its vehicle S6G5T-8, for 12 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 424 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 S6G5T-3 in the Treatment of Acne Vulgaris
• Actual Study Start Date: Dec 21, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S6G5T-3 Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks.	Drug: S6G5T-3; Once a day topical cream; Other Names: Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)
Placebo Comparator: S6G5T-8 Vehicle Cream Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks.	Drug: S6G5T-8; Once a day topical cream; Other Names: Vehicle

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline [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)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.

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

   Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.

3. Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12 [Baseline, Week 12]

   Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

Secondary Outcome Measures

1. Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12 [Baseline, Week 12]

   Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

2. Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12 [Baseline, Week 12]

   Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.

3. Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face) [Baseline and Week 12]

   Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst, in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 ("no pimples at all") to 10 ("pimples as bad as you can imagine").

4. Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face [Baseline and Week 12]

   Percent of participants in each treatment group achieving at least a 4-point reduction on Item 5 (Embarrassment) of the patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst in the 24 hours prior to administration on an 11-point NRS ranging from 0 ("not embarrassed at all") to 10 ("extremely embarrassed").

5. Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8 [Baseline, Week 8]

   Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

6. Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8 [Baseline, Week 8]

   Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.

7. Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4 [Baseline, Week 4]

   Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

8. Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4 [Baseline, Week 4]

   Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

2. Male and female 9 years of age and older.

3. Have 2 or fewer cysts or nodules.

Exclusion Criteria:

1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter (mm) in diameter).

2. Acne conglobata, acne fulminans, and secondary acne (for example, chloracne, drug-induced acne).

3. History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma).

4. Underlying disease that requires the use of interfering topical or systemic therapy.

5. Other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Consulting Services	High Point	North Carolina	United States	27262

Sponsors and Collaborators

• Sol-Gel Technologies, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Nov 1, 2018
• Statistical Analysis Plan - Nov 26, 2019

More Information

Publications

None provided.

• Responsible Party: Sol-Gel Technologies, Ltd.
• ClinicalTrials.gov Identifier: NCT03761784
• Other Study ID Numbers: SGT-65-04
• First Posted: Dec 3, 2018
• Last Update Posted: Dec 16, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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.: Acne Vulgaris
• Additional relevant MeSH terms: Acne Vulgaris; Tretinoin; Benzoyl Peroxide

Study Results

Participant Flow

Pre-assignment Detail	Participants were randomized to receive either S6G5T-3 (Encapsulated Benzoyl Peroxide [E-BPO] and Encapsulated Tretinoin [E-ATRA] Cream, 3%/0.1% [E-BPO/E-ATRA Cream, 3%/0.1%]) or vehicle in a 2:1 ratio.

Arm/Group Title	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Period Title: Overall Study
STARTED	281	143
Received at Least 1 Dose of Study Drug	274	139
COMPLETED	249	131
NOT COMPLETED	32	12

Baseline Characteristics

Arm/Group Title	S6G5T-3	S6G5T-8 Vehicle Cream	Total
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.	Total of all reporting groups
Overall Participants	281	143	424
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	20.9 (8.48)	21.4 (8.62)	21.1 (8.52)
Sex: Female, Male (Count of Participants)
Female	175 62.3%	83 58%	258 60.8%
Male	106 37.7%	60 42%	166 39.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	102 36.3%	44 30.8%	146 34.4%
Not Hispanic or Latino	178 63.3%	98 68.5%	276 65.1%
Unknown or Not Reported	1 0.4%	1 0.7%	2 0.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%	1 0.7%	2 0.5%
Asian	26 9.3%	10 7%	36 8.5%
Native Hawaiian or Other Pacific Islander	1 0.4%	2 1.4%	3 0.7%
Black or African American	53 18.9%	20 14%	73 17.2%
White	194 69%	109 76.2%	303 71.5%
More than one race	6 2.1%	1 0.7%	7 1.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Baseline Acne Lesion Count on the Face (Lesions) [Mean (Standard Deviation) ]
Inflammatory Lesions	33.5 (14.62)	33.5 (14.69)	33.5 (14.63)
Non-Inflammatory lesions	48.6 (20.24)	47.1 (19.97)	48.1 (20.14)
Baseline Investigator's Global Assessment (IGA) (Count of Participants)
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	251 89.3%	132 92.3%	383 90.3%
4 - Severe	30 10.7%	11 7.7%	41 9.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
Description	Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.
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. Multiple imputation (MCMC) was used to impute missing values.

Arm/Group Title	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Number [percentage of participants]	38.5 13.7%	11.5 8%

2. Primary Outcome

Title	Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Description	Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. 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	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Least Squares Mean (Standard Deviation) [Inflammatory Lesions]	-21.6 (10.67)	-14.8 (11.03)

3. Primary Outcome

Title	Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Description	Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective 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	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Least Squares Mean (Standard Deviation) [Non-Inflammatory Lesions]	-29.7 (15.26)	-19.8 (15.84)

4. Secondary Outcome

Title	Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Description	Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective 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	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Least Squares Mean (Standard Deviation) [Percent Change]	-61.6 (31.38)	-40.9 (32.63)

5. Secondary Outcome

Title	Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Description	Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. 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	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Least Squares Mean (Standard Deviation) [Percent Change]	-66.1 (32.28)	-43.5 (32.87)

6. Secondary Outcome

Title	Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
Description	Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst, in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 ("no pimples at all") to 10 ("pimples as bad as you can imagine").
Time Frame	Baseline and 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	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Number [percentage of participants]	38.9 13.8%	18.6 13%

7. Secondary Outcome

Title	Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
Description	Percent of participants in each treatment group achieving at least a 4-point reduction on Item 5 (Embarrassment) of the patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst in the 24 hours prior to administration on an 11-point NRS ranging from 0 ("not embarrassed at all") to 10 ("extremely embarrassed").
Time Frame	Baseline and 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	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Number [percentage of participants]	42.8 15.2%	32.7 22.9%

8. Secondary Outcome

Title	Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
Description	Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Time Frame	Baseline, Week 8

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	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Least Squares Mean (Standard Deviation) [Non-Inflammatory Lesions]	-24.4 (16.44)	-16.9 (15.60)

9. Secondary Outcome

Title	Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
Description	Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Time Frame	Baseline, Week 8

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	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Least Squares Mean (Standard Deviation) [Inflammatory Lesions]	-17.2 (12.10)	-12.5 (11.61)

10. Secondary Outcome

Title	Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
Description	Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Time Frame	Baseline, Week 4

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	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Least Squares Mean (Standard Deviation) [Non-Inflammatory Lesions]	-18.5 (14.16)	-13.4 (13.99)

11. Secondary Outcome

Title	Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
Description	Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Time Frame	Baseline, Week 4

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	S6G5T-3	S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.	Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Measure Participants	281	143
Least Squares Mean (Standard Deviation) [Inflammatory Lesions]	-13.5 (10.32)	-9.8 (10.28)

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.
Arm/Group Title	S6G5T-3		S6G5T-8 Vehicle Cream
Arm/Group Description	Participants topically applied S6G5T-3, once daily to face for 12 weeks.		Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
All Cause Mortality
	S6G5T-3		S6G5T-8 Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/274 (0%)		0/139 (0%)
Serious Adverse Events
	S6G5T-3		S6G5T-8 Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/274 (0%)		0/139 (0%)
Other (Not Including Serious) Adverse Events
	S6G5T-3		S6G5T-8 Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	69/274 (25.2%)		8/139 (5.8%)
General disorders
Application site pain	33/274 (12%)		0/139 (0%)
Application site dryness	17/274 (6.2%)		1/139 (0.7%)
Application site erythema	14/274 (5.1%)		0/139 (0%)
Application site exfoliation	14/274 (5.1%)		0/139 (0%)
Application site dermatitis	4/274 (1.5%)		1/139 (0.7%)
Application site irritation	4/274 (1.5%)		0/139 (0%)
Infections and infestations
Upper respiratory tract infection	6/274 (2.2%)		3/139 (2.2%)
Nervous system disorders
Headache	3/274 (1.1%)		1/139 (0.7%)
Psychiatric disorders
Attention deficit/hyperactivity disorder	0/274 (0%)		2/139 (1.4%)

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.