Acne VulgarisNCT01446237
U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne
A study testing acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5% in people with Acne Vulgaris, run by Stiefel, a GSK Company at 9 sites in United States.
Trial summary
This study is being conducted to obtain safety, efficacy, and satisfaction data on the combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jun 2011to 15 Dec 2011
- Phase
- Interventional
- 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
- Male or female ages 12 to 35 years, inclusive at time of consent.
- ISGA score of 3 or 4 at Baseline.
- Lesion counts meeting all of the following criteria: A: A minimum of 25 but not more than 50 facial inflammatory lesions (papules and pustules), excluding nasal lesions. B: A minimum of 20 but not more than 100 facial non-inflammatory lesions (open and closed comedones), excluding nasal lesions. C: No more than 3 facial nodular lesions (<5mm), with no cystic lesions.
- Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- Negative urine pregnancy test for females of childbearing potential.
- Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
Who cannot join
- Female who is pregnant, trying to become pregnant, or breast feeding.
- History of lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, polycystic ovary syndrome, hirsutism, or perioral dermatitis. (Subjects with Seborrheic dermatitis may be enrolled if the condition has been inactive for at least 1 year and/or it does not affect the face.)
- Use of topical antibiotics on the face within the past 2 weeks or of systemic antibiotics for acne treatment within the past 4 weeks.
- Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the possibility of augmented photosensitivity.
- Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
- Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
Show all 22Show fewer
- Treatment with estrogens, including oral, implanted, injected, and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or fewer immediately prior to study enrollment. Subjects that have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to study enrollment are allowed to enroll as long as they do not expect to change the dose or drug, or to discontinue use during the study and it has not been indicated for the treatment of acne vulgaris.
- Male with facial hair that could interfere with study assessments.
- Use of topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, sulfur and derivatives, SA, alpha or beta hydroxy acids, antioxidants, anti-wrinkle, antimicrobials, glycolic acid, abradants) within the past 2 weeks. Use of superficial facial procedures, and natural/herbal products within the past 4 weeks.
- Concomitant use of medications that are reported to exacerbate acne as these may impact efficacy assessments.
- Facial procedure (eg, blue light, chemical or laser peel, microdermabrasion) performed by aesthetician, beautician, physician, nurse, or other practitioner within the past 8 weeks.
- facial skin cancer diagnosis in preceding 12 months.
- Require or desire excessive or prolonged exposure to ultraviolet light (eg, sunlight or tanning beds) during the study.
- Dermatological disorder that in the opinion of the investigator may interfere with the accurate evaluation of the subject's facial appearance.
- Any major illness within 4 weeks before study enrollment.
- Previous use of the study products.
- Use of any investigational drug or procedure within the past 4 weeks or currently participating in another clinical study.
- Known hypersensitivity or previous allergic reaction to any of the active components of the study product.
- Any other condition which, in the judgement of the investigator, would put the subject at unacceptable risk for participation in the study.
- Current drug or alcohol abuse. (Drug screening is not required.)
- Considered unable or unlikely to attend the necessary visits.
- Employee of the investigator, clinical research organization, Stiefel, a GSK company, or GlaxoSmithKline (GSK) who is involved in the study, or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee who is involved in the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
GSK Investigational Site
Austin, Texas, 78759
GSK Investigational Site
Belleville, New Jersey, 07109
GSK Investigational Site
Fremont, California, 94538
GSK Investigational Site
High Point, North Carolina, 27262
GSK Investigational Site
Knoxville, Tennessee, 37922
GSK Investigational Site
Louisville, Kentucky, 40217
GSK Investigational Site
Montclair, New Jersey, 07042
GSK Investigational Site
Rockville, Maryland, 20850
GSK Investigational Site
Stony Brook, New York, 11790
About this study
Official title: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne
This study is being conducted to obtain safety, efficacy, and satisfaction data on the combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate or severe acne will be asked to apply the commercially available, over-the-counter products Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam Rejuvenating Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment will be included.
Read the detailed description
This open-label, multicenter, study is being conducted to obtain safety, efficacy, and satisfaction data on an Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%), which includes Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advanced Acne Treatment (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid), in the treatment of moderate to severe acne. Approximately 120 male or female subjects ages 12-35 years, inclusive, with moderate or severe acne as assessed by Investigator's Global Assessment (ISGA) and lesion counts are expected to be enrolled. Subjects will be instructed to use all 3 study products as part of a complete acne treatment system; no reference therapy or control group will be included. Subjects will be instructed to apply Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advnced Acne Treatment (2.5% Benzoyl Peroxide) to the face each morning and Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid) each evening over an application period of 12 weeks.
- Conditions
- Acne Vulgaris
- Being tested
- acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%Other
over the counter acne system
| Study group | Role | What they receive |
|---|---|---|
| Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5% | Experimental | open label - no comparator; only Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5% Receives: Other: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented.
Measured: Baseline (Day 1) and Week 1, 2, 4, 8, 12
Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit
The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.
Measured: Baseline (Day 1) and Week 1, 2, 4, 8, 12
Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit
The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions).
Measured: Week 1, 2, 4, 8 and 12
Secondary outcomes (2)
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extends from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.
Measured: Baseline (Day 1) and Week 1, 2, 4, 8, 12
Mean Change in ISGA From Baseline to Each Study Visit
The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.
Measured: Baseline (Day 1) and Week 1, 2, 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study start1 Jun 2011
- Primary completion1 Dec 2011
- Study completion15 Dec 2011
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446237
- Sponsor's protocol ID
- 115576
- Status last verified
- Mar 2017
- First submitted
- 28 Jul 2011
- Last updated
- 25 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne
- ClinicalTrials.gov ID
- NCT01446237
- Acronym / sponsor ID
- 115576
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Jun 2011
- Primary completion
- 1 Dec 2011 (actual)
- Study completion
- 15 Dec 2011 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Posted 18 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to obtain safety, efficacy, and satisfaction data on the combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate or severe acne will be asked to apply the commercially available, over-the-counter products Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam Rejuvenating Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment will be included.
Detailed description
This open-label, multicenter, study is being conducted to obtain safety, efficacy, and satisfaction data on an Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%), which includes Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advanced Acne Treatment (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid), in the treatment of moderate to severe acne. Approximately 120 male or female subjects ages 12-35 years, inclusive, with moderate or severe acne as assessed by Investigator's Global Assessment (ISGA) and lesion counts are expected to be enrolled. Subjects will be instructed to use all 3 study products as part of a complete acne treatment system; no reference therapy or control group will be included. Subjects will be instructed to apply Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advnced Acne Treatment (2.5% Benzoyl Peroxide) to the face each morning and Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid) each evening over an application period of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5% | Experimental | Other: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%open label - no comparator; only Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5% |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
- Male or female ages 12 to 35 years, inclusive at time of consent.
- ISGA score of 3 or 4 at Baseline.
- Lesion counts meeting all of the following criteria: A: A minimum of 25 but not more than 50 facial inflammatory lesions (papules and pustules), excluding nasal lesions. B: A minimum of 20 but not more than 100 facial non-inflammatory lesions (open and closed comedones), excluding nasal lesions. C: No more than 3 facial nodular lesions (<5mm), with no cystic lesions.
- Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Key exclusion criteria (22 listed)
- Female who is pregnant, trying to become pregnant, or breast feeding.
- History of lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, polycystic ovary syndrome, hirsutism, or perioral dermatitis. (Subjects with Seborrheic dermatitis may be enrolled if the condition has been inactive for at least 1 year and/or it does not affect the face.)
- Use of topical antibiotics on the face within the past 2 weeks or of systemic antibiotics for acne treatment within the past 4 weeks.
- Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the possibility of augmented photosensitivity.
- Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
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 |
|---|---|---|
| acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%over the counter acne system | Other | Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5% |
Primary outcome
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
Time frame: Baseline (Day 1) and Week 1, 2, 4, 8, 12
The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented.
Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit
Time frame: Baseline (Day 1) and Week 1, 2, 4, 8, 12
The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.
Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit
Time frame: Week 1, 2, 4, 8 and 12
The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions).
2 secondary outcomes
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
Time frame: Baseline (Day 1) and Week 1, 2, 4, 8, 12
Mean Change in ISGA From Baseline to Each Study Visit
Time frame: Baseline (Day 1) and Week 1, 2, 4, 8, 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Acne Vulgaris
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
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.
GSK Clinical Trials study director
GlaxoSmithKline
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5% in people with Acne Vulgaris, run by Stiefel, a GSK Company 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 7 inclusion and 22 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 25 May 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2017). 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?
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit (time frame: Baseline (Day 1) and Week 1, 2, 4, 8, 12). The study lists 3 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 25 May 2017.