Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris

A Phase 3 study testing Trifarotene in people with Acne Vulgaris, run by Galderma R&D at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with Moderate Facial and Truncal Acne Vulgaris Read more about this study

Who is it for?: Ages 9 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: Trifarotene
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 9 sitesUnited States
Study dates: 27 Mar 2019to 23 Dec 2019
Phase: Phase 3
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 9 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

The participant was a male or female, 9 years of age or older, at Screening visit.
The participant had moderate acne at Screening and Baseline.
The participant was a female of non childbearing potential.
The participant was a female of childbearing potential with a negative pregnancy test and who was strictly abstinent or who agreed to use an effective and approved contraceptive method for the duration of the study and at least 1 months after the last study drug application.

Who cannot join

The participant had severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g., chloracne, drug induced acne, etc.).
The participant had any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant took part to the trial.
The participant had been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the participant was planning intense UV exposure during the study (i.ed, occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.).
The participant was unwilling to refrain from use of prohibited medication during the Clinical Trial.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Galderma Investigational Site
Austin, Texas, 78759
Galderma Investigational Site
Beaumont, Texas, 77701
Galderma Investigational Site
Beverly, Massachusetts, 01915
Galderma Investigational Site
Fort Smith, Arkansas, 72916
Galderma Investigational Site
Irving, Texas, 75062
Galderma Investigational Site
Pflugerville, Texas, 78660
Galderma Investigational Site
Philadelphia, Pennsylvania, 19103
Galderma Investigational Site
Portsmouth, New Hampshire, 03801
Galderma Investigational Site
Richardson, Texas, 75081

Other trials in United States

About this study

Official title: A Multi-Center Study to Evaluate Subject Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris

Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with Moderate Facial and Truncal Acne Vulgaris

Read the detailed description

There was no formal hypothesis to be tested. Approximately 50 subjects would be enrolled to evaluate the subject reported outcomes (quality of life and satisfaction survey). The sample size was not based on any formal hypothesis testing.

Conditions: Acne Vulgaris
Being tested: Trifarotene
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TrifaroteneDrug
Topical Cream

Study groups in NCT03915860
Study group	Role	What they receive
Trifarotene	Experimental	Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. Receives: Drug: Trifarotene

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24
The DLQI was validated 10-item questionnaire for participants aged >16 years that measured the dermatology-related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). The total DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 and a minimum of 0. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.
Measured: Baseline, Week 12 and Week 24
Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24
The C-DLQI are validated 10-item questionnaire for participants aged <=16 that measured the dermatology related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). Questions were scored as follows: No effect (0-1), Small effect (2-6), Moderate effect (7-12), Very large effect (13-18), Extremely large effect (19-30). The total C-DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 (Extremely large effect) and a minimum of 0 (No effect). A lower score on the C-DLQI indicates increased QOL.
Measured: Baseline, Week 12 and Week 24
Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24
The CompAQ questionnaire is a comprehensive measure of facial and truncal acne's impact on health-related QOL. The 20 questions consisted of 5 domains that assessed a variety of psychosocial and physical impacts of acne: Psychological/Emotional, Social (Judgement from Others), Social Interactions, Treatment Concerns, Physical Symptoms. Each question is assessed with a numeric score between 0 (Never) and 8 (All the time) with a total possible score range of 0 (No effect) -160 (greater adverse impact). The higher the score, the more quality of life is impaired.
Measured: Baseline, Week 12 and Week 24
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Participants Satisfaction Questionnaire included questions: a) How bothered were you by treatment side effects? : Not bothered at all, Bothered somewhat, Bothered, Bothered a great deal b) Satisfied with the time it took for treatment to work: Very satisfied, Satisfied, Somewhat satisfied, Not satisfied c) How satisfied were you with the effectiveness of the treatment? Very satisfied, Satisfied, Somewhat satisfied, Not satisfied d) How do you feel about yourself, since starting your treatment?: Very much better, A lot better, A little better, Worse. e) Overall, are you satisfied with the treatment? : Very satisfied, Satisfied, Somewhat satisfied, Not satisfied. f) Would you consider using this treatment again: Yes, No. g) Did you use the provided moisturizing lotion?: Yes, No.
Measured: Week 12 and Week 24/End of Treatment (ET)
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Participants Satisfaction Questionnaire included questions: a) How bothered were you by treatment side effects? : Not bothered at all, Bothered somewhat, Bothered, Bothered a great deal b) Satisfied with the time it took for treatment to work: Very satisfied, Satisfied, Somewhat satisfied, Not satisfied c) How satisfied were you with the effectiveness of the treatment? Very satisfied, Satisfied, Somewhat satisfied, Not satisfied d) How do you feel about yourself, since starting your treatment?: Very much better, A lot better, A little better, Worse. e) Overall, are you satisfied with the treatment? : Very satisfied, Satisfied, Somewhat satisfied, Not satisfied. f) Would you consider using this treatment again: Yes, No. g) Did you use the provided moisturizing lotion?: Yes, No.
Measured: Week 12 and Week 24/ET
Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24
EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United States (US) algorithm, with scores ranging from -0.109 (extreme problems) to 1 (no problems). A higher score indicates better health state.
Measured: Baseline, Week 12 and Week 24
Change From Baseline in EQ-5D-5L VAS at Week 12 and 24
The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility.
Measured: Baseline, Week 12 and Week 24

Secondary outcomes (4)

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 and Week 24
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 and Week 24.
Measured: Baseline, Week 12 and Week 24
Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24
The Physician's Global Assessment (PGA) was an instrument to evaluate the truncal acne severity in the shoulders, upper back and upper anterior chest areas. PGA was recorded from components collected on the 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 PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12 and Week 24. All missing values were imputed by LOCF.
Measured: Week 12 and 24
Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Percent change from Baseline was calculated as the values at Week 12 (and 24) minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF.
Measured: Baseline, Week 12 and 24
Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Percent change from Baseline was calculated as the values at Week 12 (and 24) minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF.
Measured: Baseline, Week 12 and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 201923 Dec 2019

First posted16 Apr 2019
Study start27 Mar 2019
Primary completion23 Dec 2019
Study completion23 Dec 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.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03915860
Sponsor's protocol ID: RD.06.SPR.118295
Status last verified: Apr 2019
First submitted: 12 Apr 2019
Last updated: 15 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 4
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Active, not recruiting
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Study to Evaluate Subject Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
ClinicalTrials.gov ID: NCT03915860
Acronym / sponsor ID: RD.06.SPR.118295
Conditions: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 27 Mar 2019 (actual)
Primary completion: 23 Dec 2019 (actual)
Study completion: 23 Dec 2019 (actual)
First posted: 16 Apr 2019 (actual)
Results: Posted 15 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with Moderate Facial and Truncal Acne Vulgaris

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Trifarotene	Experimental	Drug: TrifaroteneParticipants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

The participant was a male or female, 9 years of age or older, at Screening visit.
The participant had moderate acne at Screening and Baseline.
The participant was a female of non childbearing potential.
The participant was a female of childbearing potential with a negative pregnancy test and who was strictly abstinent or who agreed to use an effective and approved contraceptive method for the duration of the study and at least 1 months after the last study drug application.

Key exclusion criteria (4 listed)

The participant had severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g., chloracne, drug induced acne, etc.).
The participant had any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant took part to the trial.
The participant had been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the participant was planning intense UV exposure during the study (i.ed, occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.).
The participant was unwilling to refrain from use of prohibited medication during the Clinical Trial.

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
TrifaroteneTopical Cream	Drug	Trifarotene

Primary outcome

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24
Time frame: Baseline, Week 12 and Week 24
The DLQI was validated 10-item questionnaire for participants aged >16 years that measured the dermatology-related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). The total DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 and a minimum of 0. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.
Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24
Time frame: Baseline, Week 12 and Week 24
The C-DLQI are validated 10-item questionnaire for participants aged <=16 that measured the dermatology related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). Questions were scored as follows: No effect (0-1), Small effect (2-6), Moderate effect (7-12), Very large effect (13-18), Extremely large effect (19-30). The total C-DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 (Extremely large effect) and a minimum of 0 (No effect). A lower score on the C-DLQI indicates increased QOL.
Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24
Time frame: Baseline, Week 12 and Week 24
The CompAQ questionnaire is a comprehensive measure of facial and truncal acne's impact on health-related QOL. The 20 questions consisted of 5 domains that assessed a variety of psychosocial and physical impacts of acne: Psychological/Emotional, Social (Judgement from Others), Social Interactions, Treatment Concerns, Physical Symptoms. Each question is assessed with a numeric score between 0 (Never) and 8 (All the time) with a total possible score range of 0 (No effect) -160 (greater adverse impact). The higher the score, the more quality of life is impaired.
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Time frame: Week 12 and Week 24/End of Treatment (ET)
Participants Satisfaction Questionnaire included questions: a) How bothered were you by treatment side effects? : Not bothered at all, Bothered somewhat, Bothered, Bothered a great deal b) Satisfied with the time it took for treatment to work: Very satisfied, Satisfied, Somewhat satisfied, Not satisfied c) How satisfied were you with the effectiveness of the treatment? Very satisfied, Satisfied, Somewhat satisfied, Not satisfied d) How do you feel about yourself, since starting your treatment?: Very much better, A lot better, A little better, Worse. e) Overall, are you satisfied with the treatment? : Very satisfied, Satisfied, Somewhat satisfied, Not satisfied. f) Would you consider using this treatment again: Yes, No. g) Did you use the provided moisturizing lotion?: Yes, No.
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Time frame: Week 12 and Week 24/ET
Participants Satisfaction Questionnaire included questions: a) How bothered were you by treatment side effects? : Not bothered at all, Bothered somewhat, Bothered, Bothered a great deal b) Satisfied with the time it took for treatment to work: Very satisfied, Satisfied, Somewhat satisfied, Not satisfied c) How satisfied were you with the effectiveness of the treatment? Very satisfied, Satisfied, Somewhat satisfied, Not satisfied d) How do you feel about yourself, since starting your treatment?: Very much better, A lot better, A little better, Worse. e) Overall, are you satisfied with the treatment? : Very satisfied, Satisfied, Somewhat satisfied, Not satisfied. f) Would you consider using this treatment again: Yes, No. g) Did you use the provided moisturizing lotion?: Yes, No.
Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24
Time frame: Baseline, Week 12 and Week 24
EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United States (US) algorithm, with scores ranging from -0.109 (extreme problems) to 1 (no problems). A higher score indicates better health state.
Change From Baseline in EQ-5D-5L VAS at Week 12 and 24
Time frame: Baseline, Week 12 and Week 24
The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility.

4 secondary outcomes

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 and Week 24
Time frame: Baseline, Week 12 and Week 24
Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24
Time frame: Week 12 and 24
Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Time frame: Baseline, Week 12 and 24
Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Time frame: Baseline, Week 12 and Week 24

Results and safety

Results posted to the registry on 15 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trifarotene	47	33

Primary outcome: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24

Time frame: Baseline, Week 12 and Week 24. Mean (Standard Deviation). Unit: score on a scale

Measure	Trifarotene n = 10
Week 12	-1.8 (2.97)
Week 24	-0.5 (5.85)

Population analysed: Analysis was performed on ITT population that included all enrolled participants. Here, overall number of participants analyzed=participants with available data at Week 12 and 24.

Primary outcome: Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24

Time frame: Baseline, Week 12 and Week 24. Mean (Standard Deviation). Unit: score on a scale

Measure	Trifarotene n = 33
Week 12	-1.7 (4.28)
Week 24	-1.2 (5.03)

Population analysed: Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data at Baseline. Number analyzed=participants with available data at specified time-points.

Primary outcome: Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24

Time frame: Baseline, Week 12 and Week 24. Mean (Standard Deviation). Unit: score on a scale

Measure	Trifarotene n = 19
Week 12	-7.4 (17.39)
Week 24	-0.6 (39.96)

Primary outcome: Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)

Time frame: Week 12 and Week 24/End of Treatment (ET). Count of participants. Unit: Participants

Measure	Trifarotene n = 47
Week 12: Bothered By Treatment Side Effects: Not bothered at all	18
Week 12: Bothered By Treatment Side Effects: Bothered somewhat	15
Week 12: Bothered By Treatment Side Effects: Bothered	0
Week 12: Bothered By Treatment Side Effects: Bothered a great deal	1
Week 12: Satisfied with the time it took for treatment to work: Very satisfied	8
Week 12: Satisfied with the time it took for treatment to work: satisfied	14
Week 12: Satisfied with the time it took for treatment to work: Somewhat satisfied	9
Week 12: Satisfied with the time it took for treatment to work: Not satisfied	3

Population analysed: Analysis was performed on ITT population. Here, "number analyzed"=participants with available data at specified time-points.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of the study drug administration up to end of the study (Week 24).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trifarotene	0 of 46 (0%)	9 of 46 (19.6%)	0 of 46

Limitations and caveats (from the sponsor): Small sample size (no formal sample size calculation).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trifarotene in people with Acne Vulgaris, run by Galderma R&D at 9 sites 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 4 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 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Dec 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?

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24 (time frame: Baseline, Week 12 and Week 24). The study lists 7 primary outcomes in all. 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 NCT03915860.

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 15 Dec 2021.