Trial Outcomes & Findings for Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES) (NCT NCT04820673)

NCT ID: NCT04820673

Last Updated: 2024-10-10

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

300 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2024-10-10

Participant Flow

Participants took part in the survey at 30 investigative sites from 09 March 2021 to 04 May 2022.

A total of 300 Acne Vulgaris (AV) participants were enrolled and received treatment in this study.

Participant milestones

Participant milestones
Measure	Sarecycline Participants prescribed with commercially available sarecycline 1.5 milligram per kilogram per day (mg/kg/day), tablets, orally were followed for up for 12 weeks post-initiation of treatment.
Overall Study STARTED	300
Overall Study Safety Analysis Set	300
Overall Study Full Analysis Set (FAS)	253
Overall Study COMPLETED	262
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Sarecycline Participants prescribed with commercially available sarecycline 1.5 milligram per kilogram per day (mg/kg/day), tablets, orally were followed for up for 12 weeks post-initiation of treatment.
Overall Study Adverse Event	6
Overall Study Due to Lack of Effectiveness	1
Overall Study Pregnancy	1
Overall Study Voluntary Withdrawal	20
Overall Study Lost to Follow-up	10

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sarecycline n=300 Participants Participants prescribed with commercially available sarecycline 1.5 mg/kg/day, tablets, orally were followed for up for 12 weeks post-initiation of treatment.
Age, Categorical <=18 years	116 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	184 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	201 Participants n=5 Participants
Sex: Female, Male Male	99 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic, Latino, or of Spanish Origin	101 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	199 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	195 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	32 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	17 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	41 Participants n=5 Participants
Race/Ethnicity, Customized Race · Prefer not to answer	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Sarecycline n=253 Participants Participants prescribed with commercially available sarecycline 1.5 mg/kg/day, tablets, orally were followed for up for 12 weeks post-initiation of treatment.
Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 Signs Domain Score: Baseline	1.96 Score on a Scale Standard Deviation 0.58
Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 Signs Domain Score: Change at Week 12	-0.77 Score on a Scale Standard Deviation 0.67
Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 Impact Domain Score: Baseline	2.06 Score on a Scale Standard Deviation 0.91
Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 Impact Domain Score: Change at Week 12	-1.01 Score on a Scale Standard Deviation 1.03
Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 Emotional Impact Domain Score: Baseline	2.43 Score on a Scale Standard Deviation 0.96
Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 Emotional Impact Domain Score: Change at Week 12	-1.15 Score on a Scale Standard Deviation 1.12
Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 Social Impact Domain Score: Baseline	0.98 Score on a Scale Standard Deviation 0.99
Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 Social Impact Domain Score: Change at Week 12	-0.60 Score on a Scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: At Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sarecycline n=253 Participants Participants prescribed with commercially available sarecycline 1.5 mg/kg/day, tablets, orally were followed for up for 12 weeks post-initiation of treatment.
Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12	58.89 Percentage of Participants

Adverse Events

Sarecycline

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sarecycline n=300 participants at risk Participants prescribed with commercially available sarecycline 1.5 mg/kg/day, tablets, orally were followed for up for 12 weeks post-initiation of treatment.
Nervous system disorders Idiopathic intracranial hypertension	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.

Other adverse events

Other adverse events
Measure	Sarecycline n=300 participants at risk Participants prescribed with commercially available sarecycline 1.5 mg/kg/day, tablets, orally were followed for up for 12 weeks post-initiation of treatment.
Gastrointestinal disorders Abdominal discomfort	0.67% 2/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Gastrointestinal disorders Abdominal pain (upper)	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Gastrointestinal disorders Diarrhea	0.67% 2/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Gastrointestinal disorders Nausea	1.3% 4/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
General disorders Fatigue	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
General disorders Injury associated with device	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Infections and infestations COVID-19	0.67% 2/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Infections and infestations Folliculitis	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Infections and infestations Vulvovaginal Candidiasis	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Infections and infestations Vulvovaginal mycotic infection	0.67% 2/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Injury, poisoning and procedural complications Animal bite	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Investigations Weight Increased	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Nervous system disorders Dizziness	1.0% 3/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Nervous system disorders Headache	1.0% 3/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Nervous system disorders Migraine	0.67% 2/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Nervous system disorders Migraine with aura	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Skin and subcutaneous tissue disorders Dermatitis	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Skin and subcutaneous tissue disorders Erythema	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Skin and subcutaneous tissue disorders Intertrigo	0.33% 1/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Skin and subcutaneous tissue disorders Pruritus	1.0% 3/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
Skin and subcutaneous tissue disorders Rash	1.0% 3/300 • From start of study up to Week 12 Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.

Additional Information

Head of Global Clinical Development

Almirall S.A.

Phone: +34932913000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place