Acne VulgarisPhase 4NCT03402893
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
A Phase 4 study testing ONEXTON Topical Gel in people with Acne Vulgaris and Post Inflammatory Hyperpigmentation, run by Derm Research, PLLC at 1 site in United States.
Trial summary
This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, Post Inflammatory Hyperpigmentation
- What is being tested?
- ONEXTON Topical Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2017to 28 Feb 2018
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;
- A female is considered of childbearing potential unless she is:
- postmenopausal for at least 12 months prior to study drug administration
- without a uterus and/or both ovaries; or
- has been surgically sterile for at least 6 months prior to study drug administration
- Reliable methods of contraception are:
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- intrauterine device in use ≥ 90 days prior to study drug administration;
- barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
- vasectomized partner
- [Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.]
- Facial acne vulgaris in patients with skin of color (Fitzpatrick Type V \& VI Supplement VI) characterized by the following:
- IGA Score for acne vulgaris 3
- IGA Score for PIH 3
- Able to understand and comply with the requirements of the study and sign Informed Consent /HIPAA Authorization forms
Who cannot join
- Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
- Allergy/sensitivity to any component of the test treatment
- IGA score for acne of 2 (mild) or 4 (severe)
- IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe)
- Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).
- Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study
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- Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
- Evidence of recent alcohol or drug abuse
- History of poor cooperation, non-compliance with medical treatment, or unreliability
- Exposure to an investigational study drug within 30 days of the Baseline Visit
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. The investigators will evaluate Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and concomitant medications.
- Conditions
- Acne Vulgaris, Post Inflammatory Hyperpigmentation
- Being tested
- ONEXTON Topical Gel
- Medical subject headings
- Acne Vulgaris, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONEXTON Topical GelDrug
Onexton gel applied once daily to face
| Study group | Role | What they receive |
|---|---|---|
| single arm Onexton gel application | Experimental | Onexton gel will be supplied to all subjects and applied once daily to the face Receives: Drug: ONEXTON Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment Scale for Severity of Facial Acne
Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator.
Measured: Week 4, Week 8, Week 16
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression
Measured: Week 4, Week 8, Week 16
Secondary outcomes (4)
Percent Change in Inflammatory Lesions
The Investigator will count the number of facial (from hairline to mandibular line) inflammatory acne lesions at each study visit. Inflammatory lesions include papules, pustules and nodules.
Measured: Week 4, Week 8, Week 16
Percent Change in Non-inflammatory Lesion Count
The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.
Measured: Week 4, Week 8, Week 16
Percent Change in Total Lesion Count
The Investigator will count the number of facial inflammatory and non-inflammatory acne lesions at each study visit. These include papules, pustules, nodules, and open and closed comedones.
Measured: week 4, Week 8, Week 16
Post-Inflammatory Hyperpigmentation (PIH) Distribution
This measure as assessed by the Investigator seeks to quantify the extent to which post-inflammatory hyperpigmentation is distributed across the face, wherein 0= No PIH, 1=1-10% of the face affected, 2=11-20%, 3=21-30%, 4=31-40%, 5=41-50%, and 6=More than 50% of the face. Lower numbers reflect less severe disease.
Measured: baseline, Week 4, week 8, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start28 Jul 2017
- Primary completion15 Nov 2017
- Study completion28 Feb 2018
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derm Research, PLLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L.H. Kircik, M.D., Derm Research, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402893
- Sponsor's protocol ID
- ONX-1701
- Status last verified
- Mar 2019
- First submitted
- 11 Jan 2018
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
- ClinicalTrials.gov ID
- NCT03402893
- Acronym / sponsor ID
- ONX-1701
- Conditions
- Acne Vulgaris, Post Inflammatory Hyperpigmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Derm Research, PLLCUniversity, hospital or other
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 19 Feb 2019
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 single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. The investigators will evaluate Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and concomitant medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm Onexton gel application | Experimental | Drug: ONEXTON Topical GelOnexton gel will be supplied to all subjects and applied once daily to the face |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;
- postmenopausal for at least 12 months prior to study drug administration
- without a uterus and/or both ovaries; or
- has been surgically sterile for at least 6 months prior to study drug administration
- intrauterine device in use ≥ 90 days prior to study drug administration;
Key exclusion criteria (10 listed)
- Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
- Allergy/sensitivity to any component of the test treatment
- IGA score for acne of 2 (mild) or 4 (severe)
- IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe)
- Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).
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 |
|---|---|---|
| ONEXTON Topical GelOnexton gel applied once daily to face | Drug | single arm Onexton gel application |
Primary outcome
Investigator Global Assessment Scale for Severity of Facial Acne
Time frame: Week 4, Week 8, Week 16
Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator.
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
Time frame: Week 4, Week 8, Week 16
Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression
4 secondary outcomes
Percent Change in Inflammatory Lesions
Time frame: Week 4, Week 8, Week 16
Percent Change in Non-inflammatory Lesion Count
Time frame: Week 4, Week 8, Week 16
Percent Change in Total Lesion Count
Time frame: week 4, Week 8, Week 16
Post-Inflammatory Hyperpigmentation (PIH) Distribution
Time frame: baseline, Week 4, week 8, week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- 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.
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 4 study testing ONEXTON Topical Gel in people with Acne Vulgaris and Post Inflammatory Hyperpigmentation, run by Derm Research, PLLC 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 14 inclusion and 10 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 Apr 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 19 Feb 2019). 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?
Investigator Global Assessment Scale for Severity of Facial Acne (time frame: Week 4, Week 8, Week 16). 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 2 Apr 2019.