SGTDER45EV: A Study of DER 45-EV Gel to Treat Rosacea

• Sponsor: Sol-Gel Technologies, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00940992
• Collaborator: (none)
• Enrollment: 92
• Locations: 10
• Arms: 3
• Duration (Months): 12
• Patients Per Site: 9.2
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: DER 45 EV; Drug: Vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Range Study of DER 45 EV Gel, 1% and 5%, and Vehicle Gel in the Treatment of Rosacea
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DER 45 EV Gel, 1% DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks	Drug: DER 45 EV; Topical application to face for 12 weeks
Placebo Comparator: Vehicle Placebo Gel applied topically once a day for 12 weeks	Drug: Vehicle; Topical application to face for 12 weeks
Experimental: DER 45 EV Gel, 5% DER 45 EV Gel, 5% applied topically once a day for 12 weeks	Drug: DER 45 EV; Topical application to face for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Investigator Global Assessment (IGA) Improvement From Baseline [Baseline to Week 12 / end of treatment]

   The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).

2. Change in Inflammatory Lesion Counts From Baseline [Baseline to Week 12 / end of treatment]

   The LS mean changes from Baseline in inflammatory lesion count at Week 12.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Males and females, 18 years of age or older

• Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules)

• Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA

• Females of child-bearing potential must have negative urine pregnancy test result at baseline and must be willing to use an effective form of contraception throughout the study

Exclusion Criteria:

• Subjects who are pregnant, breast feeding, or planning a pregnancy during the study

• Allergy or sensitivity to ingredients in test product

• Any dermatological conditions of the face that may interfere with study evaluations

• Subjects unable to avoid or minimize exposure to factors that may exacerbate or trigger rosacea

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baumann Cosmetic & Research Institute	Miami	Florida	United States	33140
2	FXM Research Corp	Miami	Florida	United States	33175
3	Augusta Centre for Dermatology and Skin	Augusta	Georgia	United States	30909
4	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
5	Skin Search of Rochester, Inc	Rochester	New York	United States	14623
6	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
7	DermResearch, Inc	Austin	Texas	United States	78759
8	J & S Studies, Inc	College Station	Texas	United States	77840
9	Premier Clinical Research	Spokane	Washington	United States	99204
10	Madison Skin and Research, Inc	Madison	Wisconsin	United States	53719

Sponsors and Collaborators

• Sol-Gel Technologies, Ltd.

Investigators

• Study Director: Ofra Levy-Hacham, PhD, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sol-Gel Technologies, Ltd.
• ClinicalTrials.gov Identifier: NCT00940992
• Other Study ID Numbers: SGT DER 45 EV 09
• First Posted: Jul 17, 2009
• Last Update Posted: Jan 9, 2015
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Rosacea

Study Results

Participant Flow

Arm/Group Title	DER 45 EV Gel, 1%	Vehicle	DER 45 EV Gel, 5%
Arm/Group Description	DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks DER 45 EV: Topical application to face for 12 weeks	Placebo Gel applied topically once a day for 12 weeks Vehicle: Topical application to face for 12 weeks	DER 45 EV Gel, 5% applied topically once a day for 12 weeks DER 45 EV: Topical application to face for 12 weeks
Period Title: Overall Study
STARTED	32	30	30
COMPLETED	28	28	28
NOT COMPLETED	4	2	2

Baseline Characteristics

Arm/Group Title	DER 45 EV Gel, 1%	Vehicle	DER 45 EV Gel, 5%	Total
Arm/Group Description	DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks DER 45 EV: Topical application to face for 12 weeks	Placebo Gel applied topically once a day for 12 weeks Vehicle: Topical application to face for 12 weeks	DER 45 EV Gel, 5% applied topically once a day for 12 weeks DER 45 EV: Topical application to face for 12 weeks	Total of all reporting groups
Overall Participants	32	30	30	92
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.0 (13.50)	50.5 (12.56)	52.2 (12.66)	51.2 (12.80)
Sex: Female, Male (Count of Participants)
Female	22 68.8%	22 73.3%	23 76.7%	67 72.8%
Male	10 31.3%	8 26.7%	7 23.3%	25 27.2%
Region of Enrollment (participants) [Number]
United States	32 100%	30 100%	30 100%	92 100%
number of inflammatory lesions (number of inflammatory lesion) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of inflammatory lesion]	28.6 (27.76)	19.9 (8.64)	22.9 (16.89)	23.9 (19.76)

Outcome Measures

1. Primary Outcome

Title	Investigator Global Assessment (IGA) Improvement From Baseline
Description	The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).
Time Frame	Baseline to Week 12 / end of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DER 45 EV Gel, 1%	Vehicle	DER 45 EV Gel, 5%
Arm/Group Description	DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks DER 45 EV: Topical application to face for 12 weeks	Placebo Gel applied topically once a day for 12 weeks Vehicle: Topical application to face for 12 weeks	DER 45 EV Gel, 5% applied topically once a day for 12 weeks DER 45 EV: Topical application to face for 12 weeks
Measure Participants	32	30	30
Number [percentage of subjects]	37.5	20.0	53.3

2. Primary Outcome

Title	Change in Inflammatory Lesion Counts From Baseline
Description	The LS mean changes from Baseline in inflammatory lesion count at Week 12.
Time Frame	Baseline to Week 12 / end of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DER 45 EV Gel, 1%	Vehicle	DER 45 EV Gel, 5%
Arm/Group Description	DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks DER 45 EV: Topical application to face for 12 weeks	Placebo Gel applied topically once a day for 12 weeks Vehicle: Topical application to face for 12 weeks	DER 45 EV Gel, 5% applied topically once a day for 12 weeks DER 45 EV: Topical application to face for 12 weeks
Measure Participants	32	30	30
Least Squares Mean (95% Confidence Interval) [Inflammatory lesions]	-21.5	-8.8	-14.7

Adverse Events

Time Frame	12 weeks
Arm/Group Title	DER 45 EV Gel, 1%		Vehicle		DER 45 EV Gel, 5%
Arm/Group Description	DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks DER 45 EV: Topical application to face for 12 weeks		Placebo Gel applied topically once a day for 12 weeks Vehicle: Topical application to face for 12 weeks		DER 45 EV Gel, 5% applied topically once a day for 12 weeks DER 45 EV: Topical application to face for 12 weeks
All Cause Mortality
	DER 45 EV Gel, 1%		Vehicle		DER 45 EV Gel, 5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	DER 45 EV Gel, 1%		Vehicle		DER 45 EV Gel, 5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	DER 45 EV Gel, 1%		Vehicle		DER 45 EV Gel, 5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/32 (21.9%)		11/30 (36.7%)		7/30 (23.3%)
Gastrointestinal disorders
Diarrhoea	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Nausea	1/32 (3.1%)		0/30 (0%)		0/30 (0%)
Vomiting	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
General disorders
Application site dermatitis	1/32 (3.1%)	1	0/30 (0%)	0	0/30 (0%)	0
Application site erythema	0/32 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0
Application site pain	0/32 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0
Application site pruritus	0/32 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0
Application site reaction	0/32 (0%)	0	1/30 (3.3%)	1	1/30 (3.3%)	1
Cyst	1/32 (3.1%)		0/30 (0%)		0/30 (0%)
Infections and infestations
Bronchitis	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Cystitis	0/32 (0%)		0/30 (0%)		1/30 (3.3%)
Fungal infection	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Gastroenteritis	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Influenza	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Nasopharyngitis	2/32 (6.3%)		1/30 (3.3%)		3/30 (10%)
Post procedural infection	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Sinusitis	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Upper respiratory tract infection	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Injury, poisoning and procedural complications
Muscle strain	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Metabolism and nutrition disorders
Type 2 diabetes mellitus	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/32 (3.1%)		0/30 (0%)		0/30 (0%)
Nervous system disorders
Headache	1/32 (3.1%)		0/30 (0%)		1/30 (3.3%)
Migraine	1/32 (3.1%)		0/30 (0%)		0/30 (0%)
Psychiatric disorders
Insomnia	0/32 (0%)		1/30 (3.3%)		0/30 (0%)
Panic attack	1/32 (3.1%)		0/30 (0%)		0/30 (0%)
Reproductive system and breast disorders
Dysmenorrhoea	1/32 (3.1%)		0/30 (0%)		0/30 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/32 (0%)		0/30 (0%)		1/30 (3.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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