ACNE VULGARISPhase 1/2NCT01301586
A Novel Combination Oral Agent to Treat Acne Vulgaris
A Phase 1/2 study testing Doxycycline and S-equol and Doxycycline in people with ACNE VULGARIS, run by Nexgen Dermatologics, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females Read more about this study
- Who is it for?
- Ages 13 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- ACNE VULGARIS
- What is being tested?
- Doxycycline and S-equol and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 1/2
- 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 13 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy females 13 years of age or older
- Non-pregnant, non-lactating females
- Signed written informed consent form
- Must be able to understand and be willing to follow all study instructions
- Have a clinical diagnosis of acne vulgaris
Who cannot join
- Female subjects who are pregnant or nursing
- Any concomitant dermatologic condition that may affect outcome measures
- Concurrent use of any other medication to treat acne vulgaris
- Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study
- Are currently using any other investigational agent or device
- Have participated in any other clinical study within 90 days prior to enrollment
- Employees or family members of sponsor or research site
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Berlin Center
Boynton Beach, Florida, 33437
H G Berlin, ESQ, 561-739-5252, garyberlin17@hotmail.com
Joshua M Berlin, MD
- Recruiting
Palos Verdes Dermatology Associates
Rolling Hills Estates, California, 90274
Howard Fein, MD, 310-541-7800
HOWARD FEIN, MD
About this study
Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL ORAL ACNE TREATMENT FOR THE TREATMENT OF ACNE VULGARIS
The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females
- Conditions
- ACNE VULGARIS
- Being tested
- Doxycycline and S-equol, Doxycycline
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline and S-equolDrug
Oral doxycycline and s-equol twice a day
DoxycyclineDrug
ORAL DOXYCYCLINE TWICE A DAY
| Study group | Role | What they receive |
|---|---|---|
| Oral antibiotic plus soy extract | Active comparator | Not described Receives: Drug: Doxycycline and S-equol |
| Oral antibiotic | Active comparator | Not described Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean number of Inflammatory Lesions on the face at the beginning and end of treatment
The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.
Measured: 12 weeks
Secondary outcomes (1)
The mean number of Comedones will be evaluated at the beginning and end of treatment
A trained investigator will count the number of comedones at the beginning and end of treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACNE VULGARISStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nexgen Dermatologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joshua M Berlin, MD, Principal investigator, Study Protocol, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301586
- Sponsor's protocol ID
- 11022006
- Status last verified
- Feb 2011
- First submitted
- 16 Feb 2011
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL ORAL ACNE TREATMENT FOR THE TREATMENT OF ACNE VULGARIS
- ClinicalTrials.gov ID
- NCT01301586
- Acronym / sponsor ID
- 11022006
- Conditions
- ACNE VULGARIS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nexgen Dermatologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 23 Feb 2011 (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.
The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral antibiotic plus soy extract | Active comparator | Drug: Doxycycline and S-equol |
| Oral antibiotic | Active comparator | Drug: Doxycycline |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy females 13 years of age or older
- Non-pregnant, non-lactating females
- Signed written informed consent form
- Must be able to understand and be willing to follow all study instructions
- Have a clinical diagnosis of acne vulgaris
Key exclusion criteria (7 listed)
- Female subjects who are pregnant or nursing
- Any concomitant dermatologic condition that may affect outcome measures
- Concurrent use of any other medication to treat acne vulgaris
- Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study
- Are currently using any other investigational agent or device
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 |
|---|---|---|
| Doxycycline and S-equolOral doxycycline and s-equol twice a day | Drug | Oral antibiotic plus soy extract |
| DoxycyclineORAL DOXYCYCLINE TWICE A DAY | Drug | Oral antibiotic |
Primary outcome
The mean number of Inflammatory Lesions on the face at the beginning and end of treatment
Time frame: 12 weeks
The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.
1 secondary outcome
The mean number of Comedones will be evaluated at the beginning and end of treatment
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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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.
Joshua M Berlin, MD principal investigator
Study Protocol, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Doxycycline and S-equol and Doxycycline in people with ACNE VULGARIS, run by Nexgen Dermatologics, Inc. at 2 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact H G Berlin, ESQ (561-739-5252, garyberlin17@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean number of Inflammatory Lesions on the face at the beginning and end of treatment (time frame: 12 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 23 Feb 2011.