AcnePhase 2NCT01289574
Topical ASC-J9 Cream for Acne
A Phase 2 study testing ASC-J9 in people with Acne, run by AndroScience Corp at 7 sites in 2 countries.
Trial summary
To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne
- What is being tested?
- ASC-J9
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Feb 2011to Aug 2012
- 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 at the time of enrollment
- Facial acne, with:
- 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts);
- 20-100 noninflammatory facial lesions (open and closed comedones);
- No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter);
- Investigator's Global Assessment (IGA) acne score of 3 or 4.
Who cannot join
- Females who are pregnant or breast-feeding
- Skin diseases other than acne vulgaris
- Use of other topical or systemic treatments for acne
- Other significant medical conditions or clinically significant abnormal laboratory test results.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Taiwan6 sites
Chang Gung Memorial Hospital - Linkou Branch
Gueishan Township, Taoyuan County, 33305
Chang Gung Memorial Hospital
NiaoSong District, Kaohsiung City
Wan Fang Hospital
Taipei, Taipei, 11696
Shih Kong Wu Ho-Su Memorial Hospital
Taipei City, Taipei, 11160
Tri-Service General Hospital
Taipei City, Taipei, 11490
Taipei Medical University Hospital
Taipei City, Taipei
About this study
Official title: Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Safety and Efficacy of 0.1% and 0.025% ASC-J9 Creams Applied Topically Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris
To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.
Read the detailed description
Approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% ASC-J9 cream or vehicle control for 12 weeks. Patients will return to the clinic at Weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.
- Conditions
- Acne
- Being tested
- ASC-J9
- Keywords
- androgen receptor degradation enhancer
- 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-J9Drug
Cream for twice daily topical application to the face
| Study group | Role | What they receive |
|---|---|---|
| Vehicle control cream | Placebo comparator | Not described Receives: Drug: ASC-J9 |
| 0.025% ASC-J9 cream | Experimental | Not described Receives: Drug: ASC-J9 |
| 0.1% ASC-J9 cream | Experimental | Not described Receives: Drug: ASC-J9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Inflammatory Acne Lesion Counts
Percent change from Baseline
Measured: 12 weeks
Secondary outcomes (2)
Success on Investigator Global Assessment (IGA) at Week 12
Overall acne rated as clear, almost clear, mild, moderate, severe, very severe.
Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline
Measured: 12 weeks
Percent Change in Noninflammatory Acne Lesion Counts
Percent change from Baseline
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 posted3 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2012
- Study completionAug 2012
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 AcneStudies 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- AndroScience Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orient Europharma Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jonathan S Dosik, MD, Principal investigator, TKL ResearchChieh-Chen Huang, MD, Principal investigator, Shih Kong Wu Ho-Su Memorial HospitalChih-Hsun Yang, MD, Principal investigator, Chang Gung Memorial HospitalTing-Jui Chen, MD, Principal investigator, Wan Fang HospitalWei-Ming Wang, MD PhD, Principal investigator, Tri-Service General Hospital (TSGH)Kuo-Hsien Wang, MD, Principal investigator, Taipei Medical University HospitalJi-Chen Ho, MD, Principal investigator, Chang Gung Memorial Hospital Kaohsiung Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289574
- Sponsor's protocol ID
- ASC-J9-202
- Status last verified
- Jul 2014
- First submitted
- 2 Feb 2011
- Last updated
- 1 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Safety and Efficacy of 0.1% and 0.025% ASC-J9 Creams Applied Topically Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01289574
- Acronym / sponsor ID
- ASC-J9-202
- Conditions
- Acne
- Keywords
- androgen receptor degradation enhancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- AndroScience CorpIndustry (pharma, biotech, devices)
- Collaborators
- Orient Europharma Co., Ltd.
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Posted 25 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.
Detailed description
Approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% ASC-J9 cream or vehicle control for 12 weeks. Patients will return to the clinic at Weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle control cream | Placebo comparator | Drug: ASC-J9 |
| 0.025% ASC-J9 cream | Experimental | Drug: ASC-J9 |
| 0.1% ASC-J9 cream | Experimental | Drug: ASC-J9 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- At least 12 years of age at the time of enrollment
- Facial acne, with:
Key exclusion criteria (4 listed)
- Females who are pregnant or breast-feeding
- Skin diseases other than acne vulgaris
- Use of other topical or systemic treatments for acne
- Other significant medical conditions or clinically significant abnormal laboratory test results.
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-J9Cream for twice daily topical application to the face | Drug | 0.025% ASC-J9 cream, 0.1% ASC-J9 cream, Vehicle control cream |
Primary outcome
Percent Change in Inflammatory Acne Lesion Counts
Time frame: 12 weeks
Percent change from Baseline
2 secondary outcomes
Success on Investigator Global Assessment (IGA) at Week 12
Time frame: 12 weeks
Percent Change in Noninflammatory Acne Lesion Counts
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acne
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
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.
Jonathan S Dosik, MD principal investigator
TKL Research
Chieh-Chen Huang, MD principal investigator
Shih Kong Wu Ho-Su Memorial Hospital
Chih-Hsun Yang, MD principal investigator
Chang Gung Memorial Hospital
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASC-J9 in people with Acne, run by AndroScience Corp at 7 sites in 2 countries.
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 6 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 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan, 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 25 Jul 2014). 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 (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 1 Aug 2014.