Acne VulgarisPhase 4DUALNCT04451330
A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
A Phase 4 study testing Trifarotene cream and Doxycycline hyclate in people with Acne Vulgaris, run by Galderma R&D at 26 sites in 2 countries.
Trial summary
The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789) 50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and effective for the treatment of severe AV. 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?
- Trifarotene cream and Doxycycline hyclate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 29 Jul 2020to 26 Apr 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants with clinical diagnosis of acne vulgaris, defined by IGA score of 4 (Severe)
- Participants with at least 20 inflammatory lesions (papules and pustules) and 30 to 120 non-inflammatory lesions (open comedones and closed comedones) and no more than 2 nodules (less than [<]1 centimeter [cm] in diameter) on the face, excluding the nose
- Agrees to provide written informed consent
- Participant is a female of non-childbearing potential (premenarchal or postmenopausal [absence of menstrual bleeding for 1 year prior to Screening, without any other medical reason], hysterectomy or bilateral oophorectomy)
Who cannot join
- Participant with any acne cyst on the face
- Participants with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
- Participants with facial dermal conditions (example [e.g.] tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
- Participants who is at risk in terms of precautions, warnings, and contraindications for trifarotene or doxycycline hyclate
- Currently receiving any prescription testosterone therapy (e.g., testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone booster or prescription testosterone (e.g., dehydroepiandrosterone [DHEA], Omnadren, Sustanon, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate) or testosterone supplements (e.g., Tribulus).
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
Galderma Investigational Site
Arlington, Texas, 76011
Galderma Investigational Site
Aventura, Florida, 33180
Galderma Investigational Site
Boca Raton, Florida, 33486
Galderma Investigational Site
Charleston, South Carolina, 71913
Galderma Investigational Site
Dallas, Texas, 75246
Galderma Investigational Site
Evansville, Indiana, 47715
Galderma Investigational Site
Fort Smith, Arkansas, 72916
Galderma Investigational Site
Grapevine, Texas, 76051
Galderma Investigational Site
High Point, North Carolina, 27262
Galderma Investigational Site
Hot Springs, Arkansas, 71913
Galderma Investigational Site
Knoxville, Tennessee, 37922
Galderma Investigational Site
Las Vegas, Nevada, 89148
Galderma Investigational Site
Miramar, Florida, 33027
Galderma Investigational Site
New Albany, Indiana, 47150
Galderma Investigational Site
New Brighton, Minnesota, 55112
Galderma Investigational Site
Newnan, Georgia, 30263
Galderma Investigational Site
Newport Beach, California, 92663
Galderma Investigational Site
Pflugerville, Texas, 78660
Galderma Investigational Site
Rockville, Maryland, 20850
Galderma Investigational Site
Rogers, Arkansas, 72758
Galderma Investigational Site
San Antonio, Texas, 78218
Galderma Investigational Site
San Antonio, Texas, 78249
Galderma Investigational Site
Stony Brook, New York, 11790
Galderma Investigational Site
Sugarloaf, Pennsylvania, 18249
Galderma Investigational Site
Warren, Michigan, 48088
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study To Compare Efficacy and Safety of Trifarotene (CD5789) Cream When Used Withan Oral Antibiotic for the Treatment of Severe Acne Vulgaris
The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789) 50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and effective for the treatment of severe AV.
- Conditions
- Acne Vulgaris
- Being tested
- Trifarotene cream, Doxycycline hyclate, Trifarotene Vehicle, Doxycycline Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifarotene creamDrug
Also called AKLIEF
Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.
Doxycycline hyclateDrug
Also called DORYX MPC
Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.
Trifarotene VehicleDrug
Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.
Doxycycline PlaceboDrug
Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Trifarotene Cream + Doxycycline | Experimental | Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks. Receives: Drug: Trifarotene cream; Drug: Doxycycline hyclate |
| Trifarotene Vehicle + Doxycycline Placebo | Placebo comparator | Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks. Receives: Drug: Trifarotene Vehicle; Drug: Doxycycline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Facial Total Lesion Counts to Week 12
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.
Measured: From Baseline to Week 12
Secondary outcomes (3)
Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12
All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.
Measured: From Baseline to Week 12
Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12
Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.
Measured: From Baseline to Week 12
Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12
IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
Measured: From 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 posted30 Jun 2020
- Study start29 Jul 2020
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
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.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451330
- Sponsor's protocol ID
- RD.06.SPR.202394
- Acronym
- DUAL
- Status last verified
- Apr 2021
- First submitted
- 25 Jun 2020
- Last updated
- 10 May 2022
- 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 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study To Compare Efficacy and Safety of Trifarotene (CD5789) Cream When Used Withan Oral Antibiotic for the Treatment of Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04451330
- Acronym / sponsor ID
- DUAL / RD.06.SPR.202394
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Posted 10 May 2022
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 was to demonstrate that daily use of topical trifarotene (CD5789) 50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and effective for the treatment of severe AV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trifarotene Cream + Doxycycline | Experimental | Drug: Trifarotene cream, Drug: Doxycycline hyclateParticipants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks. |
| Trifarotene Vehicle + Doxycycline Placebo | Placebo comparator | Drug: Trifarotene Vehicle, Drug: Doxycycline PlaceboParticipants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week 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 (4 listed)
- Participants with clinical diagnosis of acne vulgaris, defined by IGA score of 4 (Severe)
- Participants with at least 20 inflammatory lesions (papules and pustules) and 30 to 120 non-inflammatory lesions (open comedones and closed comedones) and no more than 2 nodules (less than [<]1 centimeter [cm] in diameter) on the face, excluding the nose
- Agrees to provide written informed consent
- Participant is a female of non-childbearing potential (premenarchal or postmenopausal [absence of menstrual bleeding for 1 year prior to Screening, without any other medical reason], hysterectomy or bilateral oophorectomy)
Key exclusion criteria (5 listed)
- Participant with any acne cyst on the face
- Participants with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
- Participants with facial dermal conditions (example [e.g.] tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
- Participants who is at risk in terms of precautions, warnings, and contraindications for trifarotene or doxycycline hyclate
- Currently receiving any prescription testosterone therapy (e.g., testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone booster or prescription testosterone (e.g., dehydroepiandrosterone [DHEA], Omnadren, Sustanon, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate) or testosterone supplements (e.g., Tribulus).
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 |
|---|---|---|
| Trifarotene creamAlso: AKLIEFTrifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks. | Drug | Trifarotene Cream + Doxycycline |
| Doxycycline hyclateAlso: DORYX MPCDoxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks. | Drug | Trifarotene Cream + Doxycycline |
| Trifarotene VehicleTrifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks. | Drug | Trifarotene Vehicle + Doxycycline Placebo |
| Doxycycline PlaceboDoxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks. | Drug | Trifarotene Vehicle + Doxycycline Placebo |
Primary outcome
Absolute Change From Baseline in Facial Total Lesion Counts to Week 12
Time frame: From Baseline to Week 12
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.
3 secondary outcomes
Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12
Time frame: From Baseline to Week 12
Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12
Time frame: From 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 10 May 2022.
- 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.
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trifarotene cream and Doxycycline hyclate in people with Acne Vulgaris, run by Galderma R&D at 26 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 4 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Puerto Rico. 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 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 10 May 2022). 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?
Absolute Change From Baseline in Facial Total Lesion Counts to Week 12 (time frame: From 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 10 May 2022.