RosaceaPhase 2SGTDER45EVNCT00940992
A Study of DER 45-EV Gel to Treat Rosacea
A Phase 2 study testing DER 45 EV in people with Rosacea, run by Sol-Gel Technologies, Ltd. at 10 sites in United States.
Trial summary
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- DER 45 EV
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Augusta Centre for Dermatology and Skin
Augusta, Georgia, 30909
DermResearch, Inc
Austin, Texas, 78759
J & S Studies, Inc
College Station, Texas, 77840
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Madison Skin and Research, Inc
Madison, Wisconsin, 53719
Baumann Cosmetic & Research Institute
Miami, Florida, 33140
FXM Research Corp
Miami, Florida, 33175
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Skin Search of Rochester, Inc
Rochester, New York, 14623
Premier Clinical Research
Spokane, Washington, 99204
About this study
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
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DER 45 EVDrug
Topical application to face for 12 weeks
VehicleDrug
Topical application to face for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| DER 45 EV Gel, 1% | Experimental | DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks Receives: Drug: DER 45 EV |
| Vehicle | Placebo comparator | Placebo Gel applied topically once a day for 12 weeks Receives: Drug: Vehicle |
| DER 45 EV Gel, 5% | Experimental | DER 45 EV Gel, 5% applied topically once a day for 12 weeks Receives: Drug: DER 45 EV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline to Week 12 / end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sol-Gel Technologies, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ofra Levy-Hacham, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940992
- Sponsor's protocol ID
- SGT DER 45 EV 09
- Acronym
- SGTDER45EV
- Status last verified
- Dec 2014
- First submitted
- 14 Jul 2009
- Last updated
- 9 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00940992
- Acronym / sponsor ID
- SGTDER45EV / SGT DER 45 EV 09
- Conditions
- Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Sol-Gel Technologies, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Posted 9 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DER 45 EV Gel, 1% | Experimental | Drug: DER 45 EVDER 45 EV Gel, 1% topically applied once daily to face for 12 weeks |
| Vehicle | Placebo comparator | Drug: VehiclePlacebo Gel applied topically once a day for 12 weeks |
| DER 45 EV Gel, 5% | Experimental | Drug: DER 45 EVDER 45 EV Gel, 5% applied topically once a day for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DER 45 EVTopical application to face for 12 weeks | Drug | DER 45 EV Gel, 1%, DER 45 EV Gel, 5% |
| VehicleTopical application to face for 12 weeks | Drug | Vehicle |
Primary outcome
Investigator Global Assessment (IGA) Improvement From Baseline
Time frame: 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).
Change in Inflammatory Lesion Counts From Baseline
Time frame: Baseline to Week 12 / end of treatment
The LS mean changes from Baseline in inflammatory lesion count at Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rosacea
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ofra Levy-Hacham, PhD study director
Sponsor GmbH
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DER 45 EV in people with Rosacea, run by Sol-Gel Technologies, Ltd. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Assessment (IGA) Improvement From Baseline (time frame: Baseline to Week 12 / end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.