Acne VulgarisPhase 3NCT02320149
Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
A Phase 3 study testing Sarecycline in people with Acne Vulgaris, run by Almirall, S.A. at 57 sites in United States.
Trial summary
To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris Read more about this study
- Who is it for?
- Ages 9 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Sarecycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 968 participants
- Where
- 57 sitesUnited States
- Study dates
- 18 Dec 2014to 1 Feb 2017
- 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 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent or assent form
- Male/female, 9 to 45 years of age, inclusive
- Body weight between 33 and 136 kg, inclusive
- Facial acne vulgaris with:
- 20-50 inflammatory lesions (papules, pustules and nodules) 30-100 noninflammatory lesions (open and closed comedones)
- No more than 2 nodules
Show all 11Show fewer
- IGA score of moderate (3) or severe (4)
- Negative urine pregnancy test at baseline - females of childbearing potential
- Agrees to use an effective method of contraception throughout the study
- Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study
- Able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (PHI)
Who cannot join
- Has a dermatological condition of the face that could interfere with the clinical evaluations
- Has a history of any of the following:
- Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
- Pseudomembranous colitis or antibiotic associated colitis
- Treated for any type of cancer within the last 6 months
- Has known resistance to other tetracyclines
Show all 20Show fewer
- Has received any of the following treatments within 12 weeks of screening:
- Systemic retinoids
- Systemic corticosteroids
- Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone)
- Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear)
- Has used any acne affecting treatment without an appropriate washout period
- Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period
- Is pregnant, lactating or planning a pregnancy during the study period
- Has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, Cushings disease or congenital adrenal hyperplasia
- Has drug-induced acne
- Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
- Is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study
- Has previously participated in any clinical trial involving the use of sarecycline
- Is judged by the Investigator to be unsuitable for any reason
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Warner Chilcott Research Site (Site #154)
Atlanta, Georgia, 30328
Warner Chilcott Research Site (Site #120)
Augusta, Georgia, 30909
Warner Chilcott Research Site (Site #116)
Austin, Texas, 78759
Warner Chilcott Research Site (Site #155)
Beverly Hills, California, 90210
Warner Chilcott Research Site (Site #130)
Boca Raton, Florida, 33486
Warner Chilcott Research Site (Site #124)
Boise, Idaho, 83704
Warner Chilcott Research Site (Site #152)
Boynton Beach, Florida, 33437
Warner Chilcott Research Site (Site #121)
Charlottesville, Virginia, 22911
Warner Chilcott Research Site (Site #106)
Chicago, Illinois, 60611
Warner Chilcott Research Site (Site #126)
Cincinnati, Ohio, 45249
Warner Chilcott Research Site (Site #104)
Dallas, Texas, 75234
Warner Chilcott Research Site (Site #122)
Denver, Colorado, 80209
Warner Chilcott Research Site (Site #137)
Detroit, Michigan, 48202
Warner Chilcott Research Site (Site #115)
El Paso, Texas, 79902
Warner Chilcott Research Site (Site #129)
Encino, California, 91436
Warner Chilcott Research Site (Site #114)
Greer, South Carolina, 29650
Warner Chilcott Research Site (Site #149)
Gresham, Oregon, 97030
Warner Chilcott Research Site (Site #103)
Henderson, Nevada, 89074
Warner Chilcott Research Site (Site #107)
High Point, North Carolina, 27262
Warner Chilcott Research Site (Site #142)
Houston, Texas, 77004
Warner Chilcott Research Site (Site #105)
Houston, Texas, 77056
Warner Chilcott Research Site (Site #128)
Knoxville, Tennessee, 37917
Warner Chilcott Research Site (Site #150)
La Mesa, California, 91942
Warner Chilcott Research Site (Site #135)
Lake Charles, Louisiana, 70605
Warner Chilcott Research Site (Site #156)
Layton, Utah, 84041
Warner Chilcott Research Site (Site #136)
Los Angeles, California, 90045
Warner Chilcott Research Site (Site #117)
Louisville, Kentucky, 40217
Warner Chilcott Research Site (Site #153)
Metairie, Louisiana, 70006
Warner Chilcott Research Site (Site #102)
Miami, Florida, 33025
Warner Chilcott Research Site (Site #145)
Miami, Florida, 33175
Warner Chilcott Research Site (Site #109)
Nashville, Tennessee, 37215
Warner Chilcott Research Site (Site #133)
New Haven, Connecticut, 06511
Warner Chilcott Research Site (Site #146)
New York, New York, 10016
Warner Chilcott Research Site (Site #132)
New York, New York, 10075
Warner Chilcott Research Site (Site #140)
North Miami Beach, Florida, 33162
Warner Chilcott Research Site (Site #138)
Omaha, Nebraska, 68114
Warner Chilcott Research Site (Site #151)
Orange Park, Florida, 32073
Warner Chilcott Research Site (Site #112)
Plainfield, Indiana, 46168
Warner Chilcott Research Site (Site #101)
Plano, Texas, 75093
Warner Chilcott Research Site (Site #131)
Portland, Oregon, 97210
Warner Chilcott Research Site (Site #147)
Sacramento, California, 95819
Warner Chilcott Research Site (Site #141)
Salt Lake City, Utah, 84117
Warner Chilcott Research Site (Site #118)
San Antonio, Texas, 78229
Warner Chilcott Research Site (Site #123)
San Diego, California, 92117
Warner Chilcott Research Site (Site #125)
San Diego, California, 92123
Warner Chilcott Research Site (Site #108)
Sanford, Florida, 32771
Warner Chilcott Research Site (Site #139)
Santa Rosa, California, 95403
Warner Chilcott Research Site (Site #134)
Smithtown, New York, 11787
Warner Chilcott Research Site (Site #113)
South Bend, Indiana, 46617
Warner Chilcott Research Site (Site #144)
Spokane, Washington, 99204
Warner Chilcott Research Site (Site #119)
St Louis, Missouri, 63117
Warner Chilcott Research Site (Site #157)
Tustin, California, 92780
Warner Chilcott Research Site (Site #127)
Verona, New Jersey, 07044
Warner Chilcott Research Site (Site #111)
Warren, Michigan, 48088
Warner Chilcott Research Site (Site #143)
Warren, Ohio, 44483
Warner Chilcott Research Site (Site #110)
West Palm Beach, Florida, 33409
Warner Chilcott Research Site (Site #148)
Wheat Ridge, Colorado, 80033
About this study
Official title: A Randomized, Multicenter, Double-blind, Placebocontrolled Study to Evaluate the Efficacy and Safety of 1.5 mg/kg Per Day of Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris
To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- Sarecycline, Placebo
- Keywords
- acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarecyclineDrug
1.5 mg/kg/day taken orally at the same time each day,
PlaceboDrug
Placebo-matching sarecycline tablets taken orally at the same time each day.
| Study group | Role | What they receive |
|---|---|---|
| Sarecycline | Experimental | Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks. Receives: Drug: Sarecycline |
| Placebo | Placebo comparator | Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in Facial Inflammatory Lesion Counts at Week 12
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on Analysis of Covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 12
Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12
The investigator assessed the participant's inflammatory lesions on the face 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). The percentage of participants who achieved success is reported.
Measured: Baseline (Day 1) to Week 12
Secondary outcomes (15)
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 12
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 9
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 6
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 3
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 9
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Weeks 6
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 3
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 12
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 9
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 6
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 3
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 12
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 9
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 6
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Measured: Baseline (Day 1) to Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study start18 Dec 2014
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 968 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Alexandre Kaoukhov, MD, Study director, Warner Chilcott, an Affiliate of Allergan plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320149
- Sponsor's protocol ID
- SC1401
- Status last verified
- Jan 2019
- First submitted
- 15 Dec 2014
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blind, Placebocontrolled Study to Evaluate the Efficacy and Safety of 1.5 mg/kg Per Day of Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02320149
- Acronym / sponsor ID
- SC1401
- Conditions
- Acne Vulgaris
- Keywords
- acne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 968 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Allergan
- Study start
- 18 Dec 2014 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Posted 17 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarecycline | Experimental | Drug: SarecyclineSarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo-matching sarecycline tablets, taken orally once daily for 12 weeks. |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Signed informed consent or assent form
- Male/female, 9 to 45 years of age, inclusive
- Body weight between 33 and 136 kg, inclusive
- Facial acne vulgaris with:
- 20-50 inflammatory lesions (papules, pustules and nodules) 30-100 noninflammatory lesions (open and closed comedones)
Key exclusion criteria (20 listed)
- Has a dermatological condition of the face that could interfere with the clinical evaluations
- Has a history of any of the following:
- Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
- Pseudomembranous colitis or antibiotic associated colitis
- Treated for any type of cancer within the last 6 months
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 |
|---|---|---|
| Sarecycline1.5 mg/kg/day taken orally at the same time each day, | Drug | Sarecycline |
| PlaceboPlacebo-matching sarecycline tablets taken orally at the same time each day. | Drug | Placebo |
Primary outcome
Absolute Change in Facial Inflammatory Lesion Counts at Week 12
Time frame: Baseline (Day 1) to Week 12
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on Analysis of Covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12
Time frame: Baseline (Day 1) to Week 12
The investigator assessed the participant's inflammatory lesions on the face 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). The percentage of participants who achieved success is reported.
15 secondary outcomes
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
Time frame: Baseline (Day 1) to Week 12
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
Time frame: Baseline (Day 1) to Week 9
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
Time frame: Baseline (Day 1) to Week 6
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
Time frame: Baseline (Day 1) to Week 3
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
Time frame: Baseline (Day 1) to Week 9
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
Time frame: Baseline (Day 1) to Weeks 6
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
Time frame: Baseline (Day 1) to Week 3
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12
Time frame: Baseline (Day 1) to Week 12
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9
Time frame: Baseline (Day 1) to Week 9
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6
Time frame: Baseline (Day 1) to Week 6
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3
Time frame: Baseline (Day 1) to Week 3
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12
Time frame: Baseline (Day 1) to Week 12
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9
Time frame: Baseline (Day 1) to Week 9
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6
Time frame: Baseline (Day 1) to Week 6
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3
Time frame: Baseline (Day 1) to Week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Alexandre Kaoukhov, MD study director
Warner Chilcott, an Affiliate of Allergan plc
57 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 Sarecycline in people with Acne Vulgaris, run by Almirall, S.A. at 57 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 11 inclusion and 20 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 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 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. 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 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 17 May 2018). 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 in Facial Inflammatory Lesion Counts at Week 12 (time frame: Baseline (Day 1) to Week 12). The study lists 2 primary outcomes in all. 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 15 Feb 2019.