Acne VulgarisPhase 4STARTNCT04856904
Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation
A Phase 4 study testing Trifarotene Cream in people with Acne Vulgaris, run by Galderma R&D at 18 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count. Read more about this study
- Who is it for?
- Ages 17 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Trifarotene Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 28 May 2021to 30 Jun 2023
- 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 17 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter [cm]):
- Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face; and
- A minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side; and
- No more than 2 nodules (greater than or equal to [>=] 1 cm in diameter) on the face; and
- A minimum of 10 atrophic acne scars in total (>2 mm)
- Participant with a symmetrical number of the following lesions/scars on the whole face:
Show all 11Show fewer
- Inflammatory and non-inflammatory lesions; and
- Atrophic acne scars (minimum of 4 scars per half-face)
- The participant is a female of non-childbearing potential
- If a female of childbearing, potential uses oral contraceptives that are also approve for treating acne vulgaris
- Other protocol defined inclusion criteria could apply
Who cannot join
- Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment
- Participant with any acne cyst on the face or with more than 3 excoriated acne lesions
- Participant with known active or chronic allergies or suspected allergy to trifarotene or excipients of the formulation
- Participant with facial dermal conditions (for example, tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
- Participant with known impaired hepatic or renal functions, based on medical history
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States15 sites
Galderma Investigational Site #9920
Arlington, Texas, 76011
Galderma Investigational Site #8367
Arlington Heights, Illinois, 60005
Galderma Investigational Site #9928
Boynton Beach, Florida, 33437
Galderma Investigational Site #8838
Darien, Illinois, 60561
Galderma Investigational Site #8447
Fort Smith, Arkansas, 72916
Galderma Investigational Site #8108
Las Vegas, Nevada, 89148
Galderma Investigational Site #8601
Metairie, Louisiana, 70001
Galderma Investigational Site #8295
Miami, Florida, 33136
Galderma Investigational Site #8883
Miramar, Florida, 33027
Galderma Investigational Site #9936
New Orleans, Louisiana, 70130
Galderma Investigational Site #8608
Santa Monica, California, 90404
Galderma Investigational Site #8873
Scottsdale, Arizona, 85260
Galderma Investigational Site #8189
Snellville, Georgia, 30078
Galderma Investigational Site #8881
Stony Brook, New York, 11790
Galderma Investigational Site #8886
Sugarloaf, Pennsylvania, 18249
Canada2 sites
Galderma Investigational Site #9918
Peterborough, Ontario
Galderma Investigational Site #9927
Saint-Jérôme, Quebec
About this study
Official title: Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks
The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.
- Conditions
- Acne Vulgaris
- Being tested
- Trifarotene Cream, Trifarotene Vehicle Cream
- Keywords
- Acne vulgaris, Trifarotene, AKLIEF®, CD5789
- 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®
Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream to the face once daily, in the evening for 24 weeks
Trifarotene Vehicle CreamDrug
Participants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Trifarotene Vehicle Cream | Placebo comparator | Not described Receives: Drug: Trifarotene Vehicle Cream |
| Trifarotene (CD5789) 50 mcg/g Cream | Experimental | Not described Receives: Drug: Trifarotene Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24
The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.
Measured: Baseline, Week 24
Secondary outcomes (1)
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20
The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars > 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.
Measured: Baseline, up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start28 May 2021
- Primary completion8 Feb 2023
- Study completion30 Jun 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 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
- NCT04856904
- Sponsor's protocol ID
- RD.06.SPR.202395
- Other IDs
- 2020-006050-51
- Acronym
- START
- Status last verified
- Dec 2023
- First submitted
- 20 Apr 2021
- Last updated
- 11 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Schleicher S, Moore A, Rafal E, Gagne-Henley A, Johnson SM, Dhawan S, Chavda R, York JP, Sforzolini B, Holcomb K, Ablon G, Del Rosso J, Dreno B. Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study. Dermatol Ther (Heidelb). 2023 Dec;13(12):3085-3096. doi: 10.1007/s13555-023-01042-7. Epub 2023 Oct 15.
PubMed 37838987
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks
- ClinicalTrials.gov ID
- NCT04856904
- Acronym / sponsor ID
- START / RD.06.SPR.202395
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, Trifarotene, AKLIEF®, CD5789
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 28 May 2021 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Posted 11 Jun 2024
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 is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.
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 |
|---|---|---|
| Trifarotene Vehicle Cream | Placebo comparator | Drug: Trifarotene Vehicle Cream |
| Trifarotene (CD5789) 50 mcg/g Cream | Experimental | Drug: Trifarotene Cream |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter [cm]):
- Participant with a symmetrical number of the following lesions/scars on the whole face:
- The participant is a female of non-childbearing potential
- If a female of childbearing, potential uses oral contraceptives that are also approve for treating acne vulgaris
- Other protocol defined inclusion criteria could apply
Key exclusion criteria (5 listed)
- Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment
- Participant with any acne cyst on the face or with more than 3 excoriated acne lesions
- Participant with known active or chronic allergies or suspected allergy to trifarotene or excipients of the formulation
- Participant with facial dermal conditions (for example, tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
- Participant with known impaired hepatic or renal functions, based on medical history
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: AKLIEF®Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream to the face once daily, in the evening for 24 weeks | Drug | Trifarotene (CD5789) 50 mcg/g Cream |
| Trifarotene Vehicle CreamParticipants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks | Drug | Trifarotene Vehicle Cream |
Primary outcome
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24
Time frame: Baseline, Week 24
The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.
1 secondary outcome
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20
Time frame: Baseline, up to Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37838987Schleicher S, Moore A, Rafal E, Gagne-Henley A, Johnson SM, Dhawan S, Chavda R, York JP, Sforzolini B, Holcomb K, Ablon G, Del Rosso J, Dreno B. Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study. Dermatol Ther (Heidelb). 2023 Dec;13(12):3085-3096. doi: 10.1007/s13555-023-01042-7. Epub 2023 Oct 15.
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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.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trifarotene Cream in people with Acne Vulgaris, run by Galderma R&D at 18 sites in 3 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 11 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, France. 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 11 Jun 2024). 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 Total Atrophic Acne Scar Count Per Half Face at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04856904, which also lists 1 linked publication.
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 11 Jun 2024.