Acne VulgarisPhase 2NCT03307577
A Phase 2 Safety and Efficacy Study of UHE-101 Cream in Subjects With Acne Vulgaris
A Phase 2 study testing UHE-101 Cream in people with Acne Vulgaris, run by Therapeutics, Inc. at 1 site in United States.
Trial summary
UHE-101 cream, 1% ("UHE-101") is being developed for the topical treatment of acne vulgaris. The purpose of this study is to compare the safety and efficacy of twice daily topical application of UHE-101 cream for 12 weeks to its vehicle cream in subjects with facial acne vulgaris. 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?
- UHE-101 Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 31 May 2018
- Phase
- Phase 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must provide written informed consent/assent. A patient under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide informed consent for the patient. If a patient becomes 18 years of age during the study, the patient must provide written informed consent at that time to continue study participation.
- Females must be post-menopausal, surgically sterile, or use an effective method of birth control.
- Patient has moderate to severe facial acne vulgaris.
- Patient must be in good general health as determined by the investigator and supported by medical history, physical and Vital Signs exam.
Who cannot join
- Females who are pregnant, lactating, or are planning to become pregnant during the study.
- Patient has active nodulocystic acne or acne conglobate, acne fulminans, or other forms of acne (e.g., acne mechanica).
- Patient has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
- Patient has used any of the following topical anti-acne preparations or procedures on the face:
- Topical anti-acne treatments including, but not limited to, over the-counter (OTC) acne cleansers or treatments, benzoyl peroxide, antibiotics, azelaic acid, dapsone, sulfa based products, corticosteroids, and salicylic acid within two weeks of Baseline;
- Topical retinoids (e.g., tazarotene, adapalene, and tretinoin) within four weeks of Baseline;
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- Light treatments, microdermabrasion, or chemical peels within eight weeks of Baseline;
- Other topical therapy, which may materially affect the patient's acne, in the investigator's opinion.
- Patient has used any of the following systemic anti-acne medications:
- Corticosteroids (including intramuscular and intralesional injections) within four weeks of Baseline. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable;
- Antibiotics or other systemic anti-acne medications within four weeks of Baseline, with the exception of five days or less of antibiotic therapy during this period, but not within one week of Baseline;
- Androgen receptor blockers (i.e., spironolactone or flutamide) within eight weeks of Baseline; with the exception of five days or less of spironolactone therapy during this period, but not within one week of Baseline;
- Retinoid therapy (e.g., isotretinoin) within six months of Baseline;
- Vitamin A supplements (greater than 10,000 units per day) within six months of Baseline;
- Other systemic therapy, which may materially affect the patient's acne, in the investigator's opinion.
- Patient has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study.
- Patient has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article or is currently enrolled in an investigational drug, device, or biologic study.
- Patient has a history of sensitivity to any of the ingredients in the test articles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Evaluate the Safety and Efficacy of UHE-101 Cream 1% When Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris
UHE-101 cream, 1% ("UHE-101") is being developed for the topical treatment of acne vulgaris. The purpose of this study is to compare the safety and efficacy of twice daily topical application of UHE-101 cream for 12 weeks to its vehicle cream in subjects with facial acne vulgaris.
Read the detailed description
The purpose of this study is to test a topical cream (UHE-101) containing 1.0% of active drug, for 12 weeks, in boys and girls, men and women, in the treatment of facial acne.
Patients who qualify for this study will apply the study cream twice daily (once in the morning and once in the evening) for 12 weeks.
Half of the patients in this study will receive UHE-101 cream and half will receive a vehicle cream that does not include an active drug (i.e., placebo). This is a double-blind study, which means that neither the patient nor the investigator will know which cream the patient is using. The study will last about 12 weeks and will involve 5 clinic visits.
- Conditions
- Acne Vulgaris
- Being tested
- UHE-101 Cream, Vehicle Cream
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UHE-101 CreamDrug
Topical cream containing investigational drug at a concentration of 1%
Vehicle CreamOther
Topical cream containing no drug (i.e., placebo)
| Study group | Role | What they receive |
|---|---|---|
| UHE-101 cream, 1% | Experimental | Cream is applied twice a day Receives: Drug: UHE-101 Cream |
| Vehicle cream | Placebo comparator | Cream is applied twice a day Receives: Other: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA) "Success"
Proportion of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline.
Measured: Week 12
Acne Lesion Counts (Absolute Change)
Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 12.
Measured: Week 12
Secondary outcomes (7)
IGA "Success"
Proportion of subjects achieving success in each treatment group at Week 4.
Measured: Week 4
IGA "Success"
Proportion of subjects achieving success in each treatment group at Week 8.
Measured: Week 8
Acne Lesion Counts (Absolute Change)
Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 4.
Measured: Week 4
Acne Lesion Counts (Absolute Change)
Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 8.
Measured: Week 8
Acne Lesion Counts (Percent Change)
Percent change from Baseline in lesion counts in each treatment group at Week 4
Measured: Week 4
Acne Lesion Counts (Percent Change)
Percent change from Baseline in lesion counts in each treatment group at Week 8
Measured: Week 8
Acne Lesion Counts (Percent Change)
Percent change from Baseline in lesion counts in each treatment group at Week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start5 Oct 2017
- Primary completion31 May 2018
- Study completion31 May 2018
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307577
- Sponsor's protocol ID
- 000-8651-202
- Status last verified
- May 2019
- First submitted
- 5 Oct 2017
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Evaluate the Safety and Efficacy of UHE-101 Cream 1% When Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03307577
- Acronym / sponsor ID
- 000-8651-202
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 11 Oct 2017 (actual)
- 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.
UHE-101 cream, 1% ("UHE-101") is being developed for the topical treatment of acne vulgaris. The purpose of this study is to compare the safety and efficacy of twice daily topical application of UHE-101 cream for 12 weeks to its vehicle cream in subjects with facial acne vulgaris.
Detailed description
The purpose of this study is to test a topical cream (UHE-101) containing 1.0% of active drug, for 12 weeks, in boys and girls, men and women, in the treatment of facial acne.
Patients who qualify for this study will apply the study cream twice daily (once in the morning and once in the evening) for 12 weeks.
Half of the patients in this study will receive UHE-101 cream and half will receive a vehicle cream that does not include an active drug (i.e., placebo). This is a double-blind study, which means that neither the patient nor the investigator will know which cream the patient is using. The study will last about 12 weeks and will involve 5 clinic visits.
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 |
|---|---|---|
| UHE-101 cream, 1% | Experimental | Drug: UHE-101 CreamCream is applied twice a day |
| Vehicle cream | Placebo comparator | Other: Vehicle CreamCream is applied twice a day |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must provide written informed consent/assent. A patient under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide informed consent for the patient. If a patient becomes 18 years of age during the study, the patient must provide written informed consent at that time to continue study participation.
- Females must be post-menopausal, surgically sterile, or use an effective method of birth control.
- Patient has moderate to severe facial acne vulgaris.
- Patient must be in good general health as determined by the investigator and supported by medical history, physical and Vital Signs exam.
Key exclusion criteria (18 listed)
- Females who are pregnant, lactating, or are planning to become pregnant during the study.
- Patient has active nodulocystic acne or acne conglobate, acne fulminans, or other forms of acne (e.g., acne mechanica).
- Patient has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
- Patient has used any of the following topical anti-acne preparations or procedures on the face:
- Patient has used any of the following systemic anti-acne medications:
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 |
|---|---|---|
| UHE-101 CreamTopical cream containing investigational drug at a concentration of 1% | Drug | UHE-101 cream, 1% |
| Vehicle CreamTopical cream containing no drug (i.e., placebo) | Other | Vehicle cream |
Primary outcome
Investigator's Global Assessment (IGA) "Success"
Time frame: Week 12
Proportion of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline.
Acne Lesion Counts (Absolute Change)
Time frame: Week 12
Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 12.
7 secondary outcomes
IGA "Success"
Time frame: Week 4
IGA "Success"
Time frame: Week 8
Acne Lesion Counts (Absolute Change)
Time frame: Week 4
Acne Lesion Counts (Absolute Change)
Time frame: Week 8
Acne Lesion Counts (Percent Change)
Time frame: Week 4
Acne Lesion Counts (Percent Change)
Time frame: Week 8
Acne Lesion Counts (Percent Change)
Time frame: Week 12
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 24 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UHE-101 Cream in people with Acne Vulgaris, run by Therapeutics, Inc. at 1 site 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 18 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 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Investigator's Global Assessment (IGA) "Success" (time frame: Week 12). 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 24 May 2019.