Acne VulgarisNCT01501799

A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe Acne Vulgaris

A study testing adapalene 0.1% and benzoyl peroxide 2.5% topical gel and EPIDUO in people with Acne Vulgaris, run by Actavis Mid-Atlantic LLC at 25 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

EPIDUO™ (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, marketed by GALDERMA LABORATORIES, L.P., is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of adapalene and benzoyl peroxide topical gel 0.1%/2.5%,and the current study is… Read more about this study

Who is it for?: Ages 12 to 40 years
Conditions the study is for: Acne Vulgaris
What is being tested?: adapalene 0.1% and benzoyl peroxide 2.5% topical gel and EPIDUO
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 885 participants
Where: 25 sitesin 3 countries
Study dates: Jul 2011to Dec 2011
Phase: Interventional
Are there results?: None posted in the registry

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 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Male or nonpregnant female patients must be between the ages of 12 and 40 years old inclusive.
Patients who are 18 years of age or older must have provided IEC/IRB approved written informed consent. Patients between the ages of 12 to 17 years of age must have provided IEC/IRB approved written assent; this written assent must be accompanied by an IEC/IRB approved written informed consent from the patient's legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable.
Patients must have a definite clinical diagnosis of mild to severe acne vulgaris (Grade 2, Grade 3 or Grade 4 on the IGE).
Patients must have a minimum of 20 inflammatory lesions and a maximum of 100 and a minimum of 25 and a maximum of 100 non-inflammatory lesions (i.e., open and closed comedones) and no more than 2 nodulocystic lesions (i.e., nodules and cysts) at baseline. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Lesions involving the eyes, angles of the nose (i.e., the lines around your nostrils and under the nostrils) and scalp should be excluded from the count. Patients may have acne lesions on other areas of the body (e.g., on the back).
Female patients of childbearing potential must have been using accepted methods of birth control or must agree to continue to practice abstinence, from 30 days prior to study entry to 30 days after the last administration of study drug. All female patients are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Abstinence is an acceptable method of birth control. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®) Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. Female patients must have a negative urine pregnancy test at baseline. A negative result of a pregnancy test having a minimum sensitivity of at least 50 mIU/ml for hCG should be obtained.
All male patients must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug. Abstinence is an acceptable method of birth control. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD.

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Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
Patients must be willing to refrain from using any other treatments for acne vulgaris, including antibiotics, other than the investigational product, for acne present on the face. Patients may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g., benzoyl peroxide, salicylic acid).
Patients must be in good health and free from any clinically significant disease.
Patients who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.

Who cannot join

Female patients who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 5) will be excluded from study participation.
Patients who have a known hypersensitivity to benzoyl peroxide, adapalene, and other retinoids, or their excipients will be excluded from study participation.
Patients who have conditions that may interfere with the evaluation of acne vulgaris. Such conditions include, but are not limited to the following lesions on the face: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema.
Patients who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
Patients who have been treated with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 30 days prior to baseline will be excluded from study participation.
Patients who have been treated with prescription and/or over-the-counter topical medications for the treatment of acne vulgaris including antibiotics, topical corticosteroids, α-hydroxy/glycolic acid, benzoyl peroxide, or topical anti-inflammatory medications on the face within 14 days prior to baseline will be excluded from study participation.

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Patients who are currently taking or have been treated with systemic corticosteroids (including intranasal and inhaled corticosteroids) within 30 days prior to baseline will be excluded from study participation.
Patients who have started hormonal therapy or changed the dosage of their hormonal therapy within 3 months prior to baseline will be excluded from study participation. The dosage and frequency of use of any hormonal therapy started greater than 3 months prior to baseline must remain unchanged throughout the study (Visit 1 through Visit 5). Hormonal treatments include, but are not limited to, estrogenic and progestational agents such as birth control pills.
Patients who use androgen receptor blockers (such as spironolactone or flutamide) will be excluded from study participation.
Patients who have received oral retinoids (e.g., isotretinoin) within 180 days prior to study entry,or have used therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within 180 days prior to study entry, or have applied topical retinoids (e.g., tretinoin, tazarotene, adapalene) to the face within the 2 weeks prior to baseline will be excluded from study participation.
Patients who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline will be excluded from study participation.
Patients who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation.
Patients who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, patients who have any malignancy of the skin of the facial area will be excluded from study participation.
Patients who have facial hair will be excluded from study participation. Unacceptable facial hair includes, but is not limited to, beards, and long side-burns. A well-trimmed mustache is acceptable. Patients who have performed wax epilation of the face within 14 days prior to baseline will also be excluded from study participation.
Patients who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold, will be excluded from study participation.
Patients who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids and cocaine) as judged by history will be excluded from study participation.
Patients who have participated in an investigational drug study (i.e., patients have been treated with an investigational drug) within 30 days prior to baseline will be excluded from study participation. Patients who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
Patients who have been previously enrolled in this study will be excluded from study participation.
Patients who have had within 30 days prior to baseline or during the study cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, or x-ray therapy will be excluded from study participation.
Patients who have had laser therapy, and electrodessication to the facial area within 180 days prior to study entry will be excluded from participation.
Patients who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry will be excluded from participation.
Patients who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry will be excluded from study participation.
Patients who have a baseline local irritation score of 3 (severe, marked/intense) as scored using the Application Site Reaction Scale (Section 5.2) will be excluded from participation.

Trial locations and contacts

25 sites in 3 countries.

Country

City, postcode or hospital

25 sites in 3 countries

India16 sites

Bhatia Skin, Laser & Cosmetic Center
Anand Bazar, Indore, 452 001
Swarnakar Super Specialty Centre
Anand Bazar, Indore, 452 018
Raga's Skin Care
Bangalore, Bangalore, 560 061
MS Clinical Research Pvt. Ltd.
Bangalore, Bangalore, 560025
Skin & Cosmetology Clinic
Banjara Hills, Hyderabad, 500034
Chamarajpet Skin and Laser Centre
Chamarajpet, Bangalore, 560 018
Sri Gayathri Skin Care & Hair Transplant Centre
Dwarakanagar, Visakhapatnam, 530016
Rajbal Polyclinic & Research Center
Kalyan Nagar, Bangalore, 560043
Skin Clinic
RNT Marg, Indore, 452 001
Department of Skin & STD, Kempegowda Institute of Medical Sciences,
V.V. Puram, Bangalore, 560-004
Bhagwan Mahaveer Jain Hospital
Vasanthnagar, Bangalore, 560-052
Department of Dermatology, Durga Bai Deshmukh Hospital
Vidyānagar, Hyderabad, 500044
Agrawal Skin & Laser Centre
Vijayanagar, Indore, 452 010
Dayal Clinic
Visakhapatnam, Visakhapatnam, 530 016
B.V. Department of Dermatology King George Hospital
Visakhapatnam, Visakhapatnam, 530002
Skin & Cosmetology
Visakhapatnam, Visakhapatnam, 530002

Other trials in India

United States8 sites

Center for Dermatology Clinical Research Inc.
Fremont, California, 94538
Dermatology Consulting Services
High Point, North Carolina, 27262
FXM Research Corp.
Miami, Florida, 33175
FXM Research Miramar
Miramar, Florida, 33027
Adult & Pediatric Dermatology
Overland Park, Kansas, 66211
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Skin Search of Rochester Inc.
Rochester, New York, 14623
Haber Dermatology and Cosmetic Surgery Inc.
South Euclid, Ohio, 44118

Other trials in United States

Belize1 site

FXM Research International - Belize
Belize City, Belize District

About this study

Official title: A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) and Both Active Treatments to Topical Gel Placebo (Actavis Mid-Atlantic Llc) in the Treatment of Mild to Severe Acne Vulgaris

Conditions: Acne Vulgaris
Being tested: adapalene 0.1% and benzoyl peroxide 2.5% topical gel, EPIDUO, Placebo (Vehicle Gel)
Keywords: acne, adapalene/benzoyl peroxide, Epiduo, Mild to severe acne vulgaris
Medical subject headings: Acne Vulgaris

What participants receive

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

adapalene 0.1% and benzoyl peroxide 2.5% topical gelDrug
Dosage form: topical gel Dosage: A pea-sized amount was applied to each affected area of the face Frequency: once daily in the evening Duration: 12 weeks
EPIDUODrug
EPIDUO (adapalene 0.1% and benzoyl peroxide 2.5%) Gel
Placebo (Vehicle Gel)Drug
Vehicle Gel

Study groups in NCT01501799
Study group	Role	What they receive
Adapalene 0.1% and benzoyl peroxide 2.5% topical gel	Experimental	Not described Receives: Drug: adapalene 0.1% and benzoyl peroxide 2.5% topical gel
EPIDUO™ (adapalene 0.1% and benzoyl peroxide 2.5%) Gel	Active comparator	Not described Receives: Drug: EPIDUO
Vehicle Gel	Placebo comparator	Not described Receives: Drug: Placebo (Vehicle Gel)

What is being measured

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

Percent change in inflammatory and non-inflammatory lesions from Baseline to Week 12
The mean percent change from Baseline to Visit 5 (End of Treatment) in the inflammatory and non-inflammatory lesion counts.
Measured: Week 12
Treatment-emergent adverse events
All adverse events (AEs) and treatment-emergent AEs reported during the study were summarized for the safety assessment. A treatment-emergent AE was defined as any event not present prior to the initiation of treatment with the investigational products or any event present at Baseline that worsened in either intensity or frequency following exposure to investigational products.
Measured: 12 Weeks
Signs and Symptoms of Local Irritation
Patients will be evaluated for any signs and/or symptoms as separate scores of local irritation, including: erythema, dryness, burning / stinging, erosion, edema, pain, scaling, and itching using the following scale:
0 = None
1. = Mild, barely perceptible
2. = Moderate, distinctive presence
3. = Severe, marked/intense
Measured: 12 Weeks

Secondary outcomes (2)

The proportion of "success" patients at Visit 5 using the IGE
The proportion of "success" patients at Visit 5 using the IGE, where "success" was defined as a two-grade improvement.
Measured: 12 Weeks
Mean Percent Change in Total Lesion Count from Baseline to Visit 5
The mean percent change in the total lesion count from Baseline to Visit 5.
Measured: 12 Weeks

Timeline

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

Jul 2011Dec 2011

First posted29 Dec 2011 (estimated)
Study startJul 2011
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 885 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01501799
Sponsor's protocol ID: ACTA/ADAP/BP/2010
Status last verified: Dec 2011
First submitted: 27 Dec 2011
Last updated: 29 Dec 2011
Results posted: No
Data monitoring committee: 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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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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Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) and Both Active Treatments to Topical Gel Placebo (Actavis Mid-Atlantic Llc) in the Treatment of Mild to Severe Acne Vulgaris
ClinicalTrials.gov ID: NCT01501799
Acronym / sponsor ID: ACTA/ADAP/BP/2010
Conditions: Acne Vulgaris
Keywords: acne, adapalene/benzoyl peroxide, Epiduo, Mild to severe acne vulgaris
Study type: Interventional
Recruitment status: Completed
Enrolment: 885 participants (actual)
Lead sponsor: Actavis Mid-Atlantic LLCIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 29 Dec 2011 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Adapalene 0.1% and benzoyl peroxide 2.5% topical gel	Experimental	Drug: adapalene 0.1% and benzoyl peroxide 2.5% topical gel
EPIDUO™ (adapalene 0.1% and benzoyl peroxide 2.5%) Gel	Active comparator	Drug: EPIDUO
Vehicle Gel	Placebo comparator	Drug: Placebo (Vehicle Gel)

Who may qualify

Ages: 12 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Male or nonpregnant female patients must be between the ages of 12 and 40 years old inclusive.
Patients who are 18 years of age or older must have provided IEC/IRB approved written informed consent. Patients between the ages of 12 to 17 years of age must have provided IEC/IRB approved written assent; this written assent must be accompanied by an IEC/IRB approved written informed consent from the patient's legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable.
Patients must have a definite clinical diagnosis of mild to severe acne vulgaris (Grade 2, Grade 3 or Grade 4 on the IGE).
Patients must have a minimum of 20 inflammatory lesions and a maximum of 100 and a minimum of 25 and a maximum of 100 non-inflammatory lesions (i.e., open and closed comedones) and no more than 2 nodulocystic lesions (i.e., nodules and cysts) at baseline. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Lesions involving the eyes, angles of the nose (i.e., the lines around your nostrils and under the nostrils) and scalp should be excluded from the count. Patients may have acne lesions on other areas of the body (e.g., on the back).
Female patients of childbearing potential must have been using accepted methods of birth control or must agree to continue to practice abstinence, from 30 days prior to study entry to 30 days after the last administration of study drug. All female patients are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Abstinence is an acceptable method of birth control. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®) Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. Female patients must have a negative urine pregnancy test at baseline. A negative result of a pregnancy test having a minimum sensitivity of at least 50 mIU/ml for hCG should be obtained.

Key exclusion criteria (23 listed)

Female patients who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 5) will be excluded from study participation.
Patients who have a known hypersensitivity to benzoyl peroxide, adapalene, and other retinoids, or their excipients will be excluded from study participation.
Patients who have conditions that may interfere with the evaluation of acne vulgaris. Such conditions include, but are not limited to the following lesions on the face: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema.
Patients who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
Patients who have been treated with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 30 days prior to baseline will be excluded from study participation.

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
adapalene 0.1% and benzoyl peroxide 2.5% topical gelDosage form: topical gel Dosage: A pea-sized amount was applied to each affected area of the face Frequency: once daily in the evening Duration: 12 weeks	Drug	Adapalene 0.1% and benzoyl peroxide 2.5% topical gel
EPIDUOEPIDUO (adapalene 0.1% and benzoyl peroxide 2.5%) Gel	Drug	EPIDUO™ (adapalene 0.1% and benzoyl peroxide 2.5%) Gel
Placebo (Vehicle Gel)Vehicle Gel	Drug	Vehicle Gel

Primary outcome

Percent change in inflammatory and non-inflammatory lesions from Baseline to Week 12
Time frame: Week 12
The mean percent change from Baseline to Visit 5 (End of Treatment) in the inflammatory and non-inflammatory lesion counts.
Treatment-emergent adverse events
Time frame: 12 Weeks
All adverse events (AEs) and treatment-emergent AEs reported during the study were summarized for the safety assessment. A treatment-emergent AE was defined as any event not present prior to the initiation of treatment with the investigational products or any event present at Baseline that worsened in either intensity or frequency following exposure to investigational products.
Signs and Symptoms of Local Irritation
Time frame: 12 Weeks
Patients will be evaluated for any signs and/or symptoms as separate scores of local irritation, including: erythema, dryness, burning / stinging, erosion, edema, pain, scaling, and itching using the following scale: 0 = None 1. = Mild, barely perceptible 2. = Moderate, distinctive presence 3. = Severe, marked/intense

2 secondary outcomes

The proportion of "success" patients at Visit 5 using the IGE
Time frame: 12 Weeks
Mean Percent Change in Total Lesion Count from Baseline to Visit 5
Time frame: 12 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.

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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RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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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.

Nagashayana G., M.D. study director

Lotus Labs Pvt Ltd

Nermina Nakas, M.D., M.P.H. study director

Jubilant Clinsys, Inc

25 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing adapalene 0.1% and benzoyl peroxide 2.5% topical gel and EPIDUO in people with Acne Vulgaris, run by Actavis Mid-Atlantic LLC at 25 sites in 3 countries.

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 10 inclusion and 23 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 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in India, United States, Belize. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent change in inflammatory and non-inflammatory lesions from Baseline to Week 12 (time frame: Week 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?

On the ClinicalTrials.gov record for NCT01501799.

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 29 Dec 2011.