RosaceaNCT01740934
A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea
A study testing Anatabloc Cream in people with Rosacea, run by Rock Creek Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled, parallel-group study followed by an eight-week open-label extension to evaluate the safety, tolerability, and potential effects of Anatabloc Facial Cream. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Anatabloc Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 25-70 years
- diagnosed with mild to moderate rosacea
Who cannot join
- allergy or sensitivity to the study products or their components
- severe rosacea
- current use of glucocorticoids, anti-acne products, antibiotics, topical retinoids, or vasoactive drugs
- recent oral isotretinoin use
- current use of anatabine-containing supplements (ie. Anatabloc, Anatabloc Unflavored, CigRx)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Susan H. Weinkle, MD
Bradenton, Florida, 34209
Lupo Center for Aesthetic & General Dermatology
New Orleans, Louisiana, 70124
Diane Berson, MD
New York, New York, 10022
About this study
Official title: An Eight-Week, Multi-Site, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Subjects With Rosacea Followed by an Open-Label Extension
This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled, parallel-group study followed by an eight-week open-label extension to evaluate the safety, tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild to moderate rosacea.
- Conditions
- Rosacea
- Being tested
- Anatabloc Cream, Placebo Cream
- Keywords
- rosacea, anatabine, Anatabloc, dermatology
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatabloc CreamOther
subject will apply active cream topically, twice per day according to instructions
Placebo CreamOther
subject will apply placebo cream topically, twice per day according to instructions
| Study group | Role | What they receive |
|---|---|---|
| Anatabloc Cream | Active comparator | Twice daily use of active facial cream Receives: Other: Anatabloc Cream |
| Placebo Cream | Placebo comparator | Twice daily use of placebo facial cream Receives: Other: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Effects
Collected information of the safety, tolerability and adverse events, and subjective experience related to the use of Anatabloc Cream by subjects
Measured: 8 to 16 weeks
Secondary outcomes (1)
Change in the appearance of the facial skin
Change measured by comparison of questionnaire and rating scores over time
Measured: 8 to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rock Creek Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M Varga, MD, Study director, Star Scientific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740934
- Sponsor's protocol ID
- RCP-012
- Status last verified
- Oct 2015
- First submitted
- 30 Nov 2012
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-Week, Multi-Site, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Subjects With Rosacea Followed by an Open-Label Extension
- ClinicalTrials.gov ID
- NCT01740934
- Acronym / sponsor ID
- RCP-012
- Conditions
- Rosacea
- Keywords
- rosacea, anatabine, Anatabloc, dermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Rock Creek Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled, parallel-group study followed by an eight-week open-label extension to evaluate the safety, tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild to moderate rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatabloc Cream | Active comparator | Other: Anatabloc CreamTwice daily use of active facial cream |
| Placebo Cream | Placebo comparator | Other: Placebo CreamTwice daily use of placebo facial cream |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 25-70 years
- diagnosed with mild to moderate rosacea
Key exclusion criteria (5 listed)
- allergy or sensitivity to the study products or their components
- severe rosacea
- current use of glucocorticoids, anti-acne products, antibiotics, topical retinoids, or vasoactive drugs
- recent oral isotretinoin use
- current use of anatabine-containing supplements (ie. Anatabloc, Anatabloc Unflavored, CigRx)
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 |
|---|---|---|
| Anatabloc Creamsubject will apply active cream topically, twice per day according to instructions | Other | Anatabloc Cream |
| Placebo Creamsubject will apply placebo cream topically, twice per day according to instructions | Other | Placebo Cream |
Primary outcome
Adverse Effects
Time frame: 8 to 16 weeks
Collected information of the safety, tolerability and adverse events, and subjective experience related to the use of Anatabloc Cream by subjects
1 secondary outcome
Change in the appearance of the facial skin
Time frame: 8 to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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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.
M Varga, MD study director
Star Scientific
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatabloc Cream in people with Rosacea, run by Rock Creek Pharmaceuticals, Inc. at 3 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 2 inclusion and 5 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Effects (time frame: 8 to 16 weeks). 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 2 Nov 2015; AzTrials last refreshed its copy on 29 Oct 2026.