Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DER 45 EV Gel, 1% | Experimental | DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks |
|
| Vehicle | Placebo Comparator | Placebo Gel applied topically once a day for 12 weeks |
|
| DER 45 EV Gel, 5% | Experimental | DER 45 EV Gel, 5% applied topically once a day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DER 45 EV | Drug | Topical application to face for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) Improvement From Baseline | 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). | Baseline to Week 12 / end of treatment |
| Change in Inflammatory Lesion Counts From Baseline | The LS mean changes from Baseline in inflammatory lesion count at Week 12. | Baseline to Week 12 / end of treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ofra Levy-Hacham, PhD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baumann Cosmetic & Research Institute | Miami | Florida | 33140 | United States | ||
| FXM Research Corp |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DER 45 EV Gel, 1% | DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks DER 45 EV: Topical application to face for 12 weeks |
| FG001 | Vehicle | Placebo Gel applied topically once a day for 12 weeks Vehicle: Topical application to face for 12 weeks |
| FG002 | DER 45 EV Gel, 5% | DER 45 EV Gel, 5% applied topically once a day for 12 weeks DER 45 EV: Topical application to face for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DER 45 EV Gel, 1% | DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks DER 45 EV: Topical application to face for 12 weeks |
| BG001 | Vehicle | Placebo Gel applied topically once a day for 12 weeks Vehicle: Topical application to face for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator Global Assessment (IGA) Improvement From Baseline | 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). | Posted | Number | percentage of subjects | Baseline to Week 12 / end of treatment |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DER 45 EV Gel, 1% | DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks DER 45 EV: Topical application to face for 12 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dermatitis | General disorders | MedRA Version 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ofra Levy-Hacham, Ph.D, VP of Quality Assurance | Solgel | 972-8-9313433 | 3802 | ofra.levy-hacham@sol-gel.com |
Not provided
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle | Drug | Topical application to face for 12 weeks |
|
| Miami |
| Florida |
| 33175 |
| United States |
| Augusta Centre for Dermatology and Skin | Augusta | Georgia | 30909 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Skin Search of Rochester, Inc | Rochester | New York | 14623 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| DermResearch, Inc | Austin | Texas | 78759 | United States |
| J & S Studies, Inc | College Station | Texas | 77840 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| Madison Skin and Research, Inc | Madison | Wisconsin | 53719 | United States |
| Lost to Follow-up |
|
| BG002 | DER 45 EV Gel, 5% | DER 45 EV Gel, 5% applied topically once a day for 12 weeks DER 45 EV: Topical application to face for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| number of inflammatory lesions | minimum of 12 inflammatory lesions | Mean | Standard Deviation | number of inflammatory lesion |
|
| OG002 | DER 45 EV Gel, 5% | DER 45 EV Gel, 5% applied topically once a day for 12 weeks DER 45 EV: Topical application to face for 12 weeks |
|
|
| Primary | Change in Inflammatory Lesion Counts From Baseline | The LS mean changes from Baseline in inflammatory lesion count at Week 12. | Posted | Least Squares Mean | 95% Confidence Interval | Inflammatory lesions | Baseline to Week 12 / end of treatment |
|
|
|
| 0 |
| 32 |
| 7 |
| 32 |
| EG001 | Vehicle | Placebo Gel applied topically once a day for 12 weeks Vehicle: Topical application to face for 12 weeks | 0 | 30 | 11 | 30 |
| EG002 | DER 45 EV Gel, 5% | DER 45 EV Gel, 5% applied topically once a day for 12 weeks DER 45 EV: Topical application to face for 12 weeks | 0 | 30 | 7 | 30 |
| Application site erythema | General disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Application site pain | General disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Application site pruritus | General disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Application site reaction | General disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Cyst | General disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedRA Version 14.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedRA Version 14.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedRA Version 14.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedRA Version 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedRA Version 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedRA Version 14.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedRA Version 14.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedRA Version 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedRA Version 14.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedRA Version 14.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedRA Version 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedRA Version 14.0 | Systematic Assessment |
|
Not provided