Acne VulgarisPROSESNCT04820673

Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)

An observational study of Acne Vulgaris, run by Almirall, S.A. at 2 sites in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 9 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: Sarecycline
How many people: 300 participants
Where: 2 sitesUnited States
Study dates: 9 Mar 2021to 4 May 2022
Phase: Observational
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

Study population: Patients with moderate to severe non-nodular acne vulgaris who are on prescribed sarecycline will be enrolled. Caregivers of eligible pediatric patients will also be enrolled.

Who may be able to join

Patient Inclusion Criteria:
Male or female, aged 9 years and above
Has facial non-nodular AV with IGA score of moderate or severe
Considered as a potential candidate for sarecycline (Seysara®) treatment, per clinician judgment
Caregiver Inclusion Criteria:
Primary caregiver of the study-eligible patient
Male or female, aged 18 years and above

Who cannot join

Patients with any known resistance to other tetracyclines
Patients with any dermatological or physical condition of the face that could interfere with the AV clinical evaluations.
Patients with any history of allergy to tetracycline-class antibiotics, pseudomembranous colitis or antibiotic-associated colitis.
Unable to comply with the requirements of the study or patients who in the opinion of the Site Investigator should not participate in the study
Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Almirall Site#2
Boston, Massachusetts, 02116
Almirall Site #1
Brooklyn, New York, 11201

Other trials in United States

About this study

Official title: A Real-world Prospective Cohort Study of Patients With Moderate to Severe Acne Vulgaris Treated With Sarecycline (Seysara®) In Community Practice Settings in the U.S

The purpose of this study is to evaluate the patient-reported outcomes (PROs) in terms of health-related quality of life (HRQoL) and signs of Acne Vulgaris (AV) among patients with moderate to severe non-nodular AV who are administered sarecycline (Seysara®) in real-world community practice settings in the United States (U.S). Investigator's Global Assessment (IGA) of AV and safety measures associated with use of sarecycline (Seysara®) will be assessed over the study observation period of 12 weeks. Clinicians will prescribe sarecycline (Seyara®) as per their own clinical judgment and standard practice.

Conditions: Acne Vulgaris
Being tested: Sarecycline
Keywords: Prospective, Non-nodular Acne Vulgaris, Perceptions, Health-Related Quality of Life (HRQoL), Patient-Reported Outcomes (PROs), Signs & Symptoms
Medical subject headings: Acne Vulgaris, Signs and Symptoms

What participants receive

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

SarecyclineDrug
Also called Seysara®
Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice.

Study groups in NCT04820673
Study group	Role	What they receive
Sarecycline		Eligible patients prescribed with commercially available sarecycline will be followed-up for 12 weeks post-initiation of treatment. Receives: Drug: Sarecycline

What is being measured

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

Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12
Patient related outcome (PROs) assessment performed using ASIS Questionnaire, a 17-item questionnaire that asks participants about the signs, impact (emotional and social) of AV, responses were reported as two scales: Signs (9 items), and Impact (8 items). Impact domain had two sub-scales, pertinent to Emotional (6 items) and Social impact (2 items). All items are scored on a 5-point scale: 0 (best) to 4 (worst). A domain score is determined by the average of scores in each scale within the domain. The total score is the average of all 17 items. Higher scores on the ASIS Sign domain, comprised of all items that assess symptoms (items 1-9), indicate the presence of more severe symptoms, whereas higher scores on the ASIS Impact domain, comprised of all the items that assess impacts (items 10-17), indicate a greater negative impact of acne.
Measured: Baseline, Week 12

Secondary outcomes (1)

Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12
The investigator assessed the participant's facial acne using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). Percentage of participants who achieved facial IGA success at Week 12 were reported.
Measured: At Week 12

Timeline

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

9 Mar 20214 May 2022

First posted29 Mar 2021
Study start9 Mar 2021
Primary completion4 May 2022
Study completion4 May 2022

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 Almirall, S.A.The 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04820673
Sponsor's protocol ID: M-24001-40
Acronym: PROSES
Status last verified: Oct 2024
First submitted: 25 Mar 2021
Last updated: 10 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Real-world Prospective Cohort Study of Patients With Moderate to Severe Acne Vulgaris Treated With Sarecycline (Seysara®) In Community Practice Settings in the U.S
ClinicalTrials.gov ID: NCT04820673
Acronym / sponsor ID: PROSES / M-24001-40
Conditions: Acne Vulgaris
Keywords: Prospective, Non-nodular Acne Vulgaris, Perceptions, Health-Related Quality of Life (HRQoL), Patient-Reported Outcomes (PROs), Signs & Symptoms
Study type: Observational
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Almirall, S.A.Industry (pharma, biotech, devices)
Study start: 9 Mar 2021 (actual)
Primary completion: 4 May 2022 (actual)
Study completion: 4 May 2022 (actual)
First posted: 29 Mar 2021 (actual)
Results: Posted 10 Oct 2024

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Sarecycline	–	Drug: SarecyclineEligible patients prescribed with commercially available sarecycline will be followed-up for 12 weeks post-initiation of treatment.

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with moderate to severe non-nodular acne vulgaris who are on prescribed sarecycline will be enrolled. Caregivers of eligible pediatric patients will also be enrolled.

Key inclusion criteria (7 listed)

Male or female, aged 9 years and above
Has facial non-nodular AV with IGA score of moderate or severe
Considered as a potential candidate for sarecycline (Seysara®) treatment, per clinician judgment
Primary caregiver of the study-eligible patient
Male or female, aged 18 years and above

Key exclusion criteria (5 listed)

Patients with any known resistance to other tetracyclines
Patients with any dermatological or physical condition of the face that could interfere with the AV clinical evaluations.
Patients with any history of allergy to tetracycline-class antibiotics, pseudomembranous colitis or antibiotic-associated colitis.
Unable to comply with the requirements of the study or patients who in the opinion of the Site Investigator should not participate in the study
Other protocol defined Inclusion/Exclusion criteria may apply

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
SarecyclineAlso: Seysara®Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice.	Drug	Sarecycline

Primary outcome

Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12
Time frame: Baseline, Week 12
Patient related outcome (PROs) assessment performed using ASIS Questionnaire, a 17-item questionnaire that asks participants about the signs, impact (emotional and social) of AV, responses were reported as two scales: Signs (9 items), and Impact (8 items). Impact domain had two sub-scales, pertinent to Emotional (6 items) and Social impact (2 items). All items are scored on a 5-point scale: 0 (best) to 4 (worst). A domain score is determined by the average of scores in each scale within the domain. The total score is the average of all 17 items. Higher scores on the ASIS Sign domain, comprised of all items that assess symptoms (items 1-9), indicate the presence of more severe symptoms, whereas higher scores on the ASIS Impact domain, comprised of all the items that assess impacts (items 10-17), indicate a greater negative impact of acne.

1 secondary outcome

Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12
Time frame: At Week 12

Results and safety

Results posted to the registry on 10 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sarecycline	300	262

Primary outcome: Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: Score on a Scale

Measure	Sarecycline n = 253
Signs Domain Score: Baseline	1.96 (0.58)
Signs Domain Score: Change at Week 12	-0.77 (0.67)
Impact Domain Score: Baseline	2.06 (0.91)
Impact Domain Score: Change at Week 12	-1.01 (1.03)
Emotional Impact Domain Score: Baseline	2.43 (0.96)
Emotional Impact Domain Score: Change at Week 12	-1.15 (1.12)
Social Impact Domain Score: Baseline	0.98 (0.99)
Social Impact Domain Score: Change at Week 12	-0.60 (1.06)

Sarecycline: p <.0001, t-test, 2 sided

Population analysed: FAS included all participants within the safety population that had at least one question answered pertaining to study primary research objective and who completed their Week-12 survey.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From start of study up to Week 12. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sarecycline	1 of 300 (0.3%)	30 of 300 (10%)	0 of 300

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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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.

Study Director study director

Almirall, S.A.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Acne Vulgaris, run by Almirall, S.A. at 2 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 7 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 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?

Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 (time frame: Baseline, Week 12). 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 NCT04820673.

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 Oct 2024.