A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

• Sponsor: Dermira, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02431052
• Collaborator: (none)
• Enrollment: 420
• Locations: 34
• Arms: 5
• Duration (Months): 12
• Patients Per Site: 12.4
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Olumacostat Glasaretil; Other: Vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle QD Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks	Other: Vehicle
Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle BID Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks	Other: Vehicle
Experimental: Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks	Drug: Olumacostat Glasaretil; Other Names: DRM01B
Experimental: Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks	Drug: Olumacostat Glasaretil; Other Names: DRM01B
Experimental: Olumacostat Glasaretil Gel, 7.5% BID Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks	Drug: Olumacostat Glasaretil; Other Names: DRM01B

Outcome Measures

Primary Outcome Measures

1. Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 [Baseline and Week 12]

   Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12

2. Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 [Baseline and Week 12]

   Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12

3. Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 [Baseline and Week 12]

   Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) - Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion - Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Signed informed consent.

• Male or non-pregnant, non-lactating females.

• Age ≥ 18 years.

• Clinical diagnosis of facial acne vulgaris defined as:

• At least 20 inflammatory lesions

• At least 20 non-inflammatory lesions

• Investigator Global Assessment of 3 or greater.

Exclusion Criteria:

• Active cystic acne or acne conglobata, acne fulminans, and secondary acne.

• Two or more active nodulocystic lesions.

• Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.

• Abnormal findings on screening ECG, deemed clinically significant, by the Investigator.

• Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit.

• Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator.

• Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline.

• Treatment with systemic corticosteroids (use of intranasal and inhaled corticosteroids allowed for seasonal allergies and asthma) within 4 weeks prior to Baseline.

• Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to Baseline.

• Prescription topical retinoid use on the face within 4 weeks of Baseline (e.g., tretinoin, tazarotene, adapalene).

• Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline. Dose and frequency of use of any hormonal therapy started more than 12 weeks prior to Baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills.

• Prior use of androgen receptor blockers (such as spironolactone or flutamide).

• Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months of Baseline.

• Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Clinical Research, Inc.	Mobile	Alabama	United States	36608
2	T. Joseph Raoof, MD, Inc.	Encino	California	United States	94136
3	University Clinical Trials, Inc.	San Diego	California	United States	92123
4	Tory Sullivan MD PA	North Miami Beach	Florida	United States	33162
5	International Clinical Research - US, LLC	Sanford	Florida	United States	32771
6	MOORE Clinical Research, Inc.	Tampa	Florida	United States	33609
7	Visions Clinical Research	Wellington	Florida	United States	33414
8	DermResearch, PLLC	Louisville	Kentucky	United States	40217
9	Lawrence J. Green, MD, LLC	Rockville	Maryland	United States	20850
10	Michigan Center for Skin Care Research	Clinton Township	Michigan	United States	48038
11	Henry Ford Health System	Detroit	Michigan	United States	48202
12	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
13	Las Vegas Dermatology	Las Vegas	Nevada	United States	89144
14	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106
15	Skin Search of Rochester, Inc.	Rochester	New York	United States	14623
16	Dermatology Consulting Services	High Point	North Carolina	United States	27262
17	The Skin Wellness Center	Knoxville	Tennessee	United States	37922
18	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee	United States	37130
19	DermResearch, Inc	Austin	Texas	United States	78759
20	J&S Studies, Inc.	College Station	Texas	United States	77845
21	Center for Clinical Studies, LTD. LLP	Houston	Texas	United States	77004
22	Suzanne Bruce & Associates, PA. The Center for Skin Research	Houston	Texas	United States	77056
23	Suzanne Bruce & Associates, PA. The Center for Skin Research	Katy	Texas	United States	77494
24	Austin Institute for Clinical Research	Pflugerville	Texas	United States	78660
25	Progressive Clinical Research, PA	San Antonio	Texas	United States	78229
26	Dermatology Research Center, Inc.	Salt Lake City	Utah	United States	84117
27	The Education & Research Foundation, Inc.	Lynchburg	Virginia	United States	24501
28	Premier Clinical Research	Spokane	Washington	United States	99202
29	Kirk Barber Research	Calgary	Alberta	Canada	T2G1B1
30	Enverus Medical Research	Surrey	British Columbia	Canada	V3V0C6
31	Lynderm Research	Markham	Ontario	Canada	L3P1X2
32	Windsor Clinical Research, Inc.	Windsor	Ontario	Canada	N8W 5L7
33	Innovaderm Research Inc.	Montreal	Quebec	Canada	H2K 4L5
34	Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)	Quebec		Canada	G1V 4X7

Sponsors and Collaborators

• Dermira, Inc.

Investigators

• Study Director: Beth Zib, Dermira, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dermira, Inc.
• ClinicalTrials.gov Identifier: NCT02431052
• Other Study ID Numbers: DRM01B-ACN02
• First Posted: Apr 30, 2015
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Arm/Group Title	Olumacostat Glasaretil Gel, Vehicle QD	Olumacostat Glasaretil Gel, Vehicle BID	Olumacostat Glasaretil Gel, 4.0% QD	Olumacostat Glasaretil Gel, 7.5% QD	Olumacostat Glasaretil Gel, 7.5% BID
Arm/Group Description	Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Period Title: Overall Study
STARTED	53	50	106	110	101
COMPLETED	42	46	94	94	86
NOT COMPLETED	11	4	12	16	15

Baseline Characteristics

Arm/Group Title	Olumacostat Glasaretil Gel, Vehicle QD	Olumacostat Glasaretil Gel, Vehicle BID	Olumacostat Glasaretil Gel, 4.0% QD	Olumacostat Glasaretil Gel, 7.5% QD	Olumacostat Glasaretil Gel, 7.5% BID	Total
Arm/Group Description	Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks	Total of all reporting groups
Overall Participants	52	50	106	110	101	419
Age (Count of Participants)
<=18 years	6 11.5%	3 6%	10 9.4%	15 13.6%	14 13.9%	48 11.5%
Between 18 and 65 years	46 88.5%	47 94%	96 90.6%	95 86.4%	87 86.1%	371 88.5%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	26.8 (7.65)	26.7 (7.04)	27 (8.13)	26.4 (7.96)	25.9 (8.26)	26.5 (7.90)
Sex: Female, Male (Count of Participants)
Female	38 73.1%	39 78%	77 72.6%	83 75.5%	79 78.2%	316 75.4%
Male	14 26.9%	11 22%	29 27.4%	27 24.5%	22 21.8%	103 24.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 23.1%	9 18%	24 22.6%	27 24.5%	32 31.7%	104 24.8%
Not Hispanic or Latino	38 73.1%	41 82%	81 76.4%	83 75.5%	68 67.3%	311 74.2%
Unknown or Not Reported	2 3.8%	0 0%	1 0.9%	0 0%	1 1%	4 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 3.8%	1 2%	1 0.9%	1 0.9%	0 0%	5 1.2%
Asian	1 1.9%	2 4%	4 3.8%	6 5.5%	6 5.9%	19 4.5%
Native Hawaiian or Other Pacific Islander	1 1.9%	0 0%	2 1.9%	1 0.9%	0 0%	4 1%
Black or African American	16 30.8%	12 24%	27 25.5%	24 21.8%	20 19.8%	99 23.6%
White	28 53.8%	33 66%	69 65.1%	75 68.2%	72 71.3%	277 66.1%
More than one race	4 7.7%	2 4%	3 2.8%	3 2.7%	3 3%	15 3.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Canada	11 21.2%	12 24%	25 23.6%	25 22.7%	24 23.8%	97 23.2%
United States	41 78.8%	38 76%	81 76.4%	85 77.3%	77 76.2%	322 76.8%
Fitzpatrick Skin Type (Count of Participants)
Type I	1 1.9%	2 4%	7 6.6%	12 10.9%	5 5%	27 6.4%
Type II	9 17.3%	7 14%	17 16%	23 20.9%	20 19.8%	76 18.1%
Type III	12 23.1%	17 34%	26 24.5%	28 25.5%	30 29.7%	113 27%
Type IV	15 28.8%	13 26%	25 23.6%	22 20%	23 22.8%	98 23.4%
Type V	8 15.4%	4 8%	9 8.5%	12 10.9%	13 12.9%	46 11%
Type VI	7 13.5%	7 14%	22 20.8%	13 11.8%	10 9.9%	59 14.1%

Outcome Measures

1. Primary Outcome

Title	Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Description	Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, Vehicle QD	Olumacostat Glasaretil Gel, Vehicle BID	Olumacostat Glasaretil Gel, 4.0% QD	Olumacostat Glasaretil Gel, 7.5% QD	Olumacostat Glasaretil Gel, 7.5% BID
Arm/Group Description	Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks Olumacostat Glasaretil	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks Olumacostat Glasaretil	Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks Olumacostat Glasaretil	Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks Vehicle	Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks Vehicle
Measure Participants	52	50	106	110	101
Least Squares Mean (Standard Deviation) [Lesions]	-10.5 (9.79)	-11.0 (9.04)	-14.6 (9.22)	-14.5 (9.49)	-15.0 (9.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olumacostat Glasaretil Gel, Vehicle QD, Olumacostat Glasaretil Gel, Vehicle BID, Olumacostat Glasaretil Gel, 4.0% QD, Olumacostat Glasaretil Gel, 7.5% QD, Olumacostat Glasaretil Gel, 7.5% BID
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.

2. Primary Outcome

Title	Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Description	Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-To-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, Vehicle QD	Olumacostat Glasaretil Gel, Vehicle BID	Olumacostat Glasaretil Gel, 4.0% QD	Olumacostat Glasaretil Gel, 7.5% QD	Olumacostat Glasaretil Gel, 7.5% BID
Arm/Group Description	Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Measure Participants	52	50	106	110	101
Least Squares Mean (Standard Deviation) [Lesions]	-9.3 (15.62)	-9.3 (15.07)	-15.3 (15.17)	-13.4 (15.42)	-17.5 (15.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olumacostat Glasaretil Gel, Vehicle QD, Olumacostat Glasaretil Gel, Vehicle BID, Olumacostat Glasaretil Gel, 4.0% QD, Olumacostat Glasaretil Gel, 7.5% QD, Olumacostat Glasaretil Gel, 7.5% BID
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.

3. Primary Outcome

Title	Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12
Description	Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) - Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion - Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, Vehicle QD	Olumacostat Glasaretil Gel, Vehicle BID	Olumacostat Glasaretil Gel, 4.0% QD	Olumacostat Glasaretil Gel, 7.5% QD	Olumacostat Glasaretil Gel, 7.5% BID
Arm/Group Description	Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks	Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Measure Participants	52	50	106	110	101
Success	4 7.7%	6 12%	23 21.7%	21 19.1%	26 25.7%
Failure	48 92.3%	44 88%	83 78.3%	89 80.9%	75 74.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olumacostat Glasaretil Gel, Vehicle QD, Olumacostat Glasaretil Gel, Vehicle BID, Olumacostat Glasaretil Gel, 4.0% QD, Olumacostat Glasaretil Gel, 7.5% QD, Olumacostat Glasaretil Gel, 7.5% BID
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0055
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Cochran-Mantel-Haenszel test (vehicle treatment groups included as single combined treatment group).

Adverse Events

Time Frame	Baseline to Week 12
Adverse Event Reporting Description	The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Arm/Group Title	Olumacostat Glasaretil Gel, Vehicle QD		Olumacostat Glasaretil Gel, Vehicle BID		Olumacostat Glasaretil Gel, 4.0% QD		Olumacostat Glasaretil Gel, 7.5% QD		Olumacostat Glasaretil Gel, 7.5% BID
Arm/Group Description	Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks		Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks		Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks		Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks		Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
All Cause Mortality
	Olumacostat Glasaretil Gel, Vehicle QD		Olumacostat Glasaretil Gel, Vehicle BID		Olumacostat Glasaretil Gel, 4.0% QD		Olumacostat Glasaretil Gel, 7.5% QD		Olumacostat Glasaretil Gel, 7.5% BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/50 (0%)		0/106 (0%)		0/109 (0%)		0/101 (0%)
Serious Adverse Events
	Olumacostat Glasaretil Gel, Vehicle QD		Olumacostat Glasaretil Gel, Vehicle BID		Olumacostat Glasaretil Gel, 4.0% QD		Olumacostat Glasaretil Gel, 7.5% QD		Olumacostat Glasaretil Gel, 7.5% BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/50 (0%)		0/106 (0%)		1/109 (0.9%)		0/101 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma	0/52 (0%)		0/50 (0%)		0/106 (0%)		1/109 (0.9%)		0/101 (0%)
Other (Not Including Serious) Adverse Events
	Olumacostat Glasaretil Gel, Vehicle QD		Olumacostat Glasaretil Gel, Vehicle BID		Olumacostat Glasaretil Gel, 4.0% QD		Olumacostat Glasaretil Gel, 7.5% QD		Olumacostat Glasaretil Gel, 7.5% BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/50 (0%)		4/106 (3.8%)		6/109 (5.5%)		7/101 (6.9%)
Infections and infestations
Nasopharyngitis	0/52 (0%)		0/50 (0%)		4/106 (3.8%)		6/109 (5.5%)		7/101 (6.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.