Acne VulgarisPhase 1NCT03743038
A Study Comparing Two Topicals in the Treatment of Acne Vulgaris
A Phase 1 study testing Hydro-alcohol solution in people with Acne Vulgaris, run by Vyne Therapeutics Inc. at 1 site in United States.
Trial summary
A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23). Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Hydro-alcohol solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2018to 11 Feb 2019
- Phase
- Phase 1
- 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 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Has facial acne vulgaris with:
- 16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right and left side of the face should be similar IGA score of moderate (3) on both the right and left side of the face
Who cannot join
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
- More than two facial nodules/cysts
- Sunburn on the face
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Evaluator-Blinded, Bilateral Comparison Study of Two Topicals in the Treatment of Subjects With Acne Vulgaris
A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).
Read the detailed description
A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris. Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.
- Conditions
- Acne Vulgaris
- Being tested
- FMX101 vehicle, Hydro-alcohol solution
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMX101 vehicleDrug
Also called Test Article A
FMX101 vehicle - hydrophobic oil based vehicle (Test Article A)
Hydro-alcohol solutionOther
Also called Test Article B
Hydro-alcohol solution based vehicle (Test Article B)
| Study group | Role | What they receive |
|---|---|---|
| FMX101 vehicle | Experimental | FMX101 hydrophobic oil based vehicle (Test Article A) topically applied daily for six weeks on one side of the face (in a split-face model) Receives: Drug: FMX101 vehicle |
| Hydro-alcohol solution base | Experimental | Hydro-alcohol solution based vehicle (Test Article B) topically applied daily for six weeks on the contralateral side of the face (in a split-face model) Receives: Other: Hydro-alcohol solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6
Severity of acne vulgaris was assessed by Investigator Global Assessment (IGA). The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Low score represented best outcome and higher score value indicated worst outcome.
Measured: At Week 6
Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6
Severity of acne vulgaris was assessed by IGA. The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. The IGA treatment "success" was defined as at least a two-point improvement in IGA score relative to Baseline.
Measured: At Week 6
Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count
Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).
Measured: Day 1/ Baseline and Week 6
Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count
The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).
Measured: Day 1/ Baseline and Week 6
Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
The non-inflammatory lesion count (NILC) included open and closed comedones.
Measured: Day 1/ Baseline and Week 6
Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
The NILC included open and closed comedones.
Measured: Day 1/ Baseline and Week 6
Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7
Sebum measurement was conducted on the right and left side of the face. The sebum measurement represented the sebum score of saturation of the film and had a range of 0 to 99, where 99 equated to very oily skin.
Measured: Day 1/Baseline and Weeks 2, 4, 6 and 7
Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7
Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face.
Measured: Day 1/Baseline and Weeks 2, 4, 6 and 7
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related.
Measured: Day 1 until Week 7 (End of Study) and Unscheduled Visit
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline
The local skin reactions (LSRs) included erythema, edema, scaling/dryness, burning/stinging, pruritus, erosion, and pain) were assessed. Erythema, edema, scaling/dryness, and erosion were assessed by the investigator and burning/stinging, pain, and pruritus were assessed by the participant. Assessments was made using a 4-point ordinal scale where 0=absent, 1=mild (slight, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). Here, lower point represented no reaction and higher points represented severe reactions.The LSRs were assessed both before and 15 minutes following test article application.
Measured: Day 1 until Week 7 (End of Study) or Unscheduled Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start20 Nov 2018
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743038
- Sponsor's protocol ID
- FX2018-23
- Status last verified
- Mar 2021
- First submitted
- 10 Nov 2018
- Last updated
- 6 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-Blinded, Bilateral Comparison Study of Two Topicals in the Treatment of Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03743038
- Acronym / sponsor ID
- FX2018-23
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).
Detailed description
A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris. Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.
| Arm | Type | Receives |
|---|---|---|
| FMX101 vehicle | Experimental | Drug: FMX101 vehicleFMX101 hydrophobic oil based vehicle (Test Article A) topically applied daily for six weeks on one side of the face (in a split-face model) |
| Hydro-alcohol solution base | Experimental | Other: Hydro-alcohol solutionHydro-alcohol solution based vehicle (Test Article B) topically applied daily for six weeks on the contralateral side of the face (in a split-face model) |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Has facial acne vulgaris with:
- 16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right and left side of the face should be similar IGA score of moderate (3) on both the right and left side of the face
Key exclusion criteria (3 listed)
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
- More than two facial nodules/cysts
- Sunburn on the face
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 |
|---|---|---|
| FMX101 vehicleAlso: Test Article AFMX101 vehicle - hydrophobic oil based vehicle (Test Article A) | Drug | FMX101 vehicle |
| Hydro-alcohol solutionAlso: Test Article BHydro-alcohol solution based vehicle (Test Article B) | Other | Hydro-alcohol solution base |
Primary outcome
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6
Time frame: At Week 6
Severity of acne vulgaris was assessed by Investigator Global Assessment (IGA). The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Low score represented best outcome and higher score value indicated worst outcome.
Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6
Time frame: At Week 6
Severity of acne vulgaris was assessed by IGA. The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. The IGA treatment "success" was defined as at least a two-point improvement in IGA score relative to Baseline.
Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count
Time frame: Day 1/ Baseline and Week 6
Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).
Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count
Time frame: Day 1/ Baseline and Week 6
The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).
Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
Time frame: Day 1/ Baseline and Week 6
The non-inflammatory lesion count (NILC) included open and closed comedones.
Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
Time frame: Day 1/ Baseline and Week 6
The NILC included open and closed comedones.
Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7
Time frame: Day 1/Baseline and Weeks 2, 4, 6 and 7
Sebum measurement was conducted on the right and left side of the face. The sebum measurement represented the sebum score of saturation of the film and had a range of 0 to 99, where 99 equated to very oily skin.
Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7
Time frame: Day 1/Baseline and Weeks 2, 4, 6 and 7
Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 until Week 7 (End of Study) and Unscheduled Visit
An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related.
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline
Time frame: Day 1 until Week 7 (End of Study) or Unscheduled Visit
The local skin reactions (LSRs) included erythema, edema, scaling/dryness, burning/stinging, pruritus, erosion, and pain) were assessed. Erythema, edema, scaling/dryness, and erosion were assessed by the investigator and burning/stinging, pain, and pruritus were assessed by the participant. Assessments was made using a 4-point ordinal scale where 0=absent, 1=mild (slight, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). Here, lower point represented no reaction and higher points represented severe reactions.The LSRs were assessed both before and 15 minutes following test article application.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- 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 1 study testing Hydro-alcohol solution in people with Acne Vulgaris, run by Vyne 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 2 inclusion and 3 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 6 Apr 2021. 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 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.
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 23 Feb 2021). 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?
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 (time frame: At Week 6). The study lists 10 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 6 Apr 2021.