Acne VulgarisPhase 2NCT00525499
A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
A Phase 2 study testing ASC-J9 cream in people with Acne Vulgaris, run by AndroScience Corp at 10 sites in United States.
Trial summary
The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ASC-J9 cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2007to Jul 2008
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 12 years of age.
- Facial acne, with:
- 20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face
Who cannot join
- Women who are pregnant or breastfeeding
- Skin diseases other than acne vulgaris
- Use of oral retinoids within 6 months of Baseline Visit
- Unwilling to discontinue all other treatments for facial acne
- Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc
Austin, Texas, 78759
Northwest Clinical Trial
Boise, Idaho, 83704
J&S Studies, Inc
Bryan, Texas, 77802
East Bay Dermatology Medical Group
Fremont, California, 94538
Dermatology Associates
Knoxville, Tennessee, 37934
Education and Research Foundation
Lynchburg, Virginia, 24501
TKL Research, Inc
Paramus, New Jersey, 07652
Dermatology Research Center, Inc
Salt Lake City, Utah, 84124
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Dose-Ranging Clinical Study to Evaluate the Safety and Efficacy of ASC-J9 Cream Applied Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris
The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.
Read the detailed description
Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.
- Conditions
- Acne Vulgaris
- Being tested
- ASC-J9 cream, placebo
- Keywords
- acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC-J9 creamDrug
Topical application to the face twice daily for 12 weeks.
placeboDrug
Also called Androgen receptor degradation enhancer
vehicle control applied topically twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Vehicle control cream applied topically to the face twice daily for 12 weeks Receives: Drug: placebo |
| 2 | Experimental | 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks Receives: Drug: ASC-J9 cream |
| 3 | Experimental | 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks Receives: Drug: ASC-J9 cream |
| 4 | Experimental | 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks Receives: Drug: ASC-J9 cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12
Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.
Measured: Baseline to Week 12
Secondary outcomes (1)
Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12
The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne:
0 No acne lesions.
- Rare non-inflammatory lesions.
- Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions.
- Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion.
- Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions.
- Highly inflammatory lesions, multiple nodulo-cystic lesions.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionJul 2008
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- AndroScience Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles CY Shih, PhD, Study chair, AndroScience Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525499
- Sponsor's protocol ID
- ASC-J9-201
- Status last verified
- Nov 2011
- First submitted
- 31 Aug 2007
- Last updated
- 23 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Dose-Ranging Clinical Study to Evaluate the Safety and Efficacy of ASC-J9 Cream Applied Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00525499
- Acronym / sponsor ID
- ASC-J9-201
- Conditions
- Acne Vulgaris
- Keywords
- acne
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- AndroScience CorpIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Posted 18 Apr 2011
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 if topical ASC-J9 cream is effective in treating acne.
Detailed description
Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboVehicle control cream applied topically to the face twice daily for 12 weeks |
| 2 | Experimental | Drug: ASC-J9 cream0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
| 3 | Experimental | Drug: ASC-J9 cream0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
| 4 | Experimental | Drug: ASC-J9 cream0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- At least 12 years of age.
- Facial acne, with:
- 20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face
Key exclusion criteria (5 listed)
- Women who are pregnant or breastfeeding
- Skin diseases other than acne vulgaris
- Use of oral retinoids within 6 months of Baseline Visit
- Unwilling to discontinue all other treatments for facial acne
- Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
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 |
|---|---|---|
| ASC-J9 creamTopical application to the face twice daily for 12 weeks. | Drug | 2, 3, 4 |
| placeboAlso: Androgen receptor degradation enhancervehicle control applied topically twice daily for 12 weeks | Drug | 1 |
Primary outcome
Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12
Time frame: Baseline to Week 12
Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.
1 secondary outcome
Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Charles CY Shih, PhD study chair
AndroScience Corp
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 ASC-J9 cream in people with Acne Vulgaris, run by AndroScience Corp 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 3 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 23 Nov 2011. 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 18 Apr 2011). 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?
Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 (time frame: Baseline to Week 12). 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 Nov 2011.