A Study of S6G5T3 in the Treatment of Acne Vulgaris
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 |
---|---|---|
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
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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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. Negative least squares means values represent decrease from Baseline.
- 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
- 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.
- 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. Negative least squares means values represent decrease from Baseline.
- 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 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 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").
- 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").
- 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.
- 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. Negative least squares means values represent decrease from Baseline.
- 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.
- 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. Negative least squares means values represent decrease from Baseline.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study.
-
Male and female 9 years of age and older.
-
Have 2 or fewer cysts or nodules.
Exclusion Criteria:
-
More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter [mm] in diameter).
-
Acne conglobata, acne fulminans and secondary acne (for example, chloracne, drug-induced acne).
-
History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma).
-
Underlying disease that requires the use of interfering topical or systemic therapy.
-
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 | Sol-Gel site 501 | Tampa | Florida | United States | 33607 |
Sponsors and Collaborators
- Sol-Gel Technologies, Ltd.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- SGT-65-05
Study Results
Participant Flow
Recruitment Details | |
---|---|
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 | 290 | 144 |
Received at Least 1 Dose of Study Drug | 281 | 138 |
COMPLETED | 242 | 132 |
NOT COMPLETED | 48 | 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 | 290 | 144 | 434 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
20.1
(6.96)
|
20.3
(6.67)
|
20.1
(6.86)
|
Sex: Female, Male (Count of Participants) | |||
Female |
173
59.7%
|
77
53.5%
|
250
57.6%
|
Male |
117
40.3%
|
67
46.5%
|
184
42.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
85
29.3%
|
56
38.9%
|
141
32.5%
|
Not Hispanic or Latino |
204
70.3%
|
87
60.4%
|
291
67.1%
|
Unknown or Not Reported |
1
0.3%
|
1
0.7%
|
2
0.5%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
2
0.7%
|
2
1.4%
|
4
0.9%
|
Asian |
12
4.1%
|
6
4.2%
|
18
4.1%
|
Native Hawaiian or Other Pacific Islander |
1
0.3%
|
1
0.7%
|
2
0.5%
|
Black or African American |
52
17.9%
|
18
12.5%
|
70
16.1%
|
White |
212
73.1%
|
110
76.4%
|
322
74.2%
|
More than one race |
11
3.8%
|
7
4.9%
|
18
4.1%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Baseline Acne Lesion Count on the Face (Lesions) [Mean (Standard Deviation) ] | |||
Inflammatory Lesions |
28.2
(8.70)
|
27.5
(8.52)
|
28.0
(8.64)
|
Non-Inflammatory Lesions |
44.6
(18.03)
|
44.9
(18.82)
|
44.7
(18.27)
|
Baseline Investigator's Global Assessment (IGA) (Count of Participants) | |||
0 - Clean |
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 |
262
90.3%
|
133
92.4%
|
395
91%
|
4 - Severe |
28
9.7%
|
10
6.9%
|
38
8.8%
|
Outcome Measures
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. MCMC was used to impute missing values. Here, 'Overall Number of Participants Analyzed' (N) signifies number of participants evaluable for this outcome measure. |
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 | 290 | 143 |
Number [percentage of participants] |
25.4
8.8%
|
14.7
10.2%
|
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. 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. 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 | 290 | 144 |
Least Squares Mean (Standard Deviation) [Inflammatory Lesions] |
-16.2
(9.07)
|
-14.1
(8.68)
|
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 | 290 | 144 |
Least Squares Mean (Standard Deviation) [Non-Inflammatory Lesions] |
-24.2
(15.82)
|
-17.4
(15.82)
|
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 | 290 | 144 |
Least Squares Mean (Standard Deviation) [Percent Change] |
-54.4
(32.28)
|
-41.5
(33.44)
|
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. 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 | 290 | 144 |
Least Squares Mean (Standard Deviation) [Percent Change] |
-57.6
(32.41)
|
-50.8
(31.17)
|
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 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 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 | 290 | 144 |
Number [Percentage of Participants] |
35.1
12.1%
|
27.2
18.9%
|
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 | 290 | 144 |
Number [Percentage of Participants] |
33.9
11.7%
|
37.1
25.8%
|
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 | 290 | 144 |
Least Squares Mean (Standard Deviation) [Non-Inflammatory Lesions] |
-20.0
(16.43)
|
-12.8
(16.21)
|
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. 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 | 290 | 144 |
Least Squares Mean (Standard Deviation) [Inflammatory Lesions] |
-14.0
(8.57)
|
-12.5
(8.57)
|
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 | 290 | 144 |
Least Squares Mean (Standard Deviation) [Non-Inflammatory Lesions] |
-14.6
(14.51)
|
-10.8
(14.88)
|
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. 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 | 290 | 144 |
Least Squares Mean (Standard Deviation) [Inflammatory Lesions] |
-10.7
(7.94)
|
-10.1
(7.81)
|
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 | 0/281 (0%) | 0/138 (0%) | ||
Serious Adverse Events |
||||
S6G5T-3 | S6G5T-8 Vehicle Cream | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/281 (0.4%) | 1/138 (0.7%) | ||
Psychiatric disorders | ||||
Depression | 1/281 (0.4%) | 1/138 (0.7%) | ||
Bipolar II disorder | 0/281 (0%) | 1/138 (0.7%) | ||
Conduct disorder | 0/281 (0%) | 1/138 (0.7%) | ||
Other (Not Including Serious) Adverse Events |
||||
S6G5T-3 | S6G5T-8 Vehicle Cream | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 68/281 (24.2%) | 4/138 (2.9%) | ||
Gastrointestinal disorders | ||||
Application site exfoliation | 9/281 (3.2%) | 0/138 (0%) | ||
General disorders | ||||
Application site pain | 27/281 (9.6%) | 1/138 (0.7%) | ||
Application site dryness | 10/281 (3.6%) | 0/138 (0%) | ||
Application site erythema | 8/281 (2.8%) | 0/138 (0%) | ||
Application site dermatitis | 5/281 (1.8%) | 0/138 (0%) | ||
Application site pruritus | 5/281 (1.8%) | 0/138 (0%) | ||
Application site photosensitivity | 3/281 (1.1%) | 1/138 (0.7%) | ||
Infections and infestations | ||||
Nasopharyngitis | 4/281 (1.4%) | 0/138 (0%) | ||
Viral upper respiratory tract infection | 1/281 (0.4%) | 2/138 (1.4%) |
Limitations/Caveats
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.
Results Point of Contact
Name/Title | Sol-Gel |
---|---|
Organization | Sol-Gel Technologies, Ltd. |
Phone | 972-8-9313433 |
info@sol-gel.com |
- SGT-65-05