RosaceaPhase 3NCT03287791
A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea
A Phase 3 study testing Generic Azelaic Acid Foam, Finacea® (Azelaic Acid) Foam and Cleanser in people with Rosacea, run by Actavis Inc. at 26 sites in United States.
Trial summary
The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- Generic Azelaic Acid Foam, Finacea® (Azelaic Acid) Foam and Cleanser
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 924 participants
- Where
- 26 sitesUnited States
- Study dates
- 19 Jul 2016to 22 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants had to be willing and able to provide written informed consent for the study
- Healthy males or non-pregnant females ≥18 years-of-age with a clinical diagnosis of moderate facial rosacea
- Participants had to have at least 8 and not more than 50 inflammatory facial lesions (that is, papules/pustules) and ≤2 nodules on the face. For the purposes of study treatment and evaluation, these lesions were limited to the facial treatment area including those present on the nose. Lesions involving the eyes and scalp were excluded from the count.
- Participants had to have persistent erythema on the face with moderate (3) score
- Participants had to have a mild (1) to moderate (2) score for telangiectasia on the face
- Participants had to have a definite clinical diagnosis of moderate facial rosacea (severity score 3)
Show all 12Show fewer
- Participants had to be willing to minimize external factors that might trigger rosacea flare-ups (for example, spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds, and alcoholic beverages) during the course of the study
- Participants had to be in general good health and free from any clinically significant disease other than rosacea on the face, that could have interfered with the study evaluations
- Participants had to be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and able to complete the study
- Male participants and female participants of childbearing potential had to use accepted methods of birth control or had to agree to practice abstinence, from study start to 30 days after the last administration of study drug. All female participants were considered to be of childbearing potential unless they had been surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or had been postmenopausal for at least a year. Any of the following methods of birth control were acceptable: oral contraceptives, contraceptive patches/implants (for example, Norplant®), vaginal ring (NuvaRing®), Depo-Provera® (Medroxy progesterone acetate), double barrier methods (for example, condom and spermicide), or intrauterine device
- Female participants of child bearing potential had to have a negative urine pregnancy test at baseline
- Participants who used make-up had to have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and had to agree to use the same make-up, brand/type, or frequency of use, throughout the study
Who cannot join
- Pregnant or lactating or planning to become pregnant during the study period
- Presence of any skin condition on the face that could have interfered with the diagnosis or assessment of rosacea
- Excessive facial hair (for example, beards, sideburns, moustaches) that would interfere could have interfered with diagnosis or assessment of rosacea
- History of hypersensitivity or allergy to azelaic acid, propylene glycol, or any other component of the formulation
- The use within 6 months prior to baseline of oral retinoids (for example, Accutane®) or therapeutic Vitamin A supplements of greater than 10,000 units/day (multivitamins were allowed)
- The use of estrogens or oral contraceptives for less than 3 months prior to baseline
Show all 29Show fewer
- The use within 1 month prior to baseline of the following:
- topical retinoids to the face
- systemic antibiotics known to have an impact on the severity of facial rosacea (for example, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim)
- systemic corticosteroids
- Use within two weeks prior to baseline of the following:
- topical corticosteroids
- topical antibiotics
- topical medications for rosacea (for example, metronidazole, azelaic acid)
- Antipruritics, including antihistamines, within 24 hours of any study visit
- Participants with moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema
- Participants with a severe irritation grade for erythema, dryness, scaling, pruritus, stinging/burning, and edema
- Ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics
- A participant who had used a sauna during the 2 weeks prior to study entry and during the study
- Participants who had performed wax epilation of the face within 14 days prior to baseline
- A participant who had a history of being unresponsive to topical azelaic acid therapy
- A participant who had any clinically significant condition or situation, other than the condition being studied that, in the opinion of the Investigator, could have interfered with the study evaluations or optimal participation in the study
- A participant who had used any topical azelaic acid therapy within 30 days of baseline visit
- Participants who had participated in an investigational drug study (for example, participants had been treated with an investigational drug) within 30 days prior to baseline were excluded from study participation. Participants who were participating in non-treatment studies such as observational studies or registry studies could be considered for inclusion
- Participants who had been previously randomized in this study
- Participants who had laser therapy (for telangiectasia or other conditions) and phototherapy to the facial area within 180 days prior to study entry
- Participants who had cosmetic procedures (for example, facials), which could affect the efficacy and safety profile of the investigational product within 14 days prior to study entry
- Employees or staff of the research site were excluded from participation in the study
- No more than 1 participant from the same household was allowed to participate in the study
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Investigative Site 19
Brandon, Florida
Investigative Site 3
Cincinnati, Ohio
Investigative Site 4
Dallas, Texas
Investigative Site 26
El Paso, Texas
Investigative Site 2
Encino, California
Investigative Site 1
Hialeah, Florida
Investigative Site 9
Hialeah, Florida
Investigative Site 8
High Point, North Carolina
Investigative Site 10
La Mesa, California
Investigative Site 23
Lauderdale Lakes, Florida
Investigative Site 11
Miami, Florida
Investigative Site 15
Miami, Florida
Investigative Site 20
Miami, Florida
Investigative Site 12
Miramar, Florida
Investigative Site 7
New Braunfels, Texas
Investigative Site 6
New Orleans, Louisiana
Investigative Site 5
Norfolk, Virginia
Investigative Site 25
Ocala, Florida
Investigative Site 17
Omaha, Nebraska
Investigative Site 22
Pembroke Pines, Florida
Investigative Site 21
Philadelphia, Pennsylvania
Investigative Site 14
Plainfield, Indiana
Investigative Site 16
Savannah, Georgia
Investigative Site 24
Spokane, Washington
Investigative Site 18
Tampa, Florida
Investigative Site 13
Wichita, Kansas
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate Safety and Clinical Equivalence of a Generic Azelaic Acid Foam, 15% and the Reference Listed Finacea® (Azelaic Acid) Foam,15% in Patients With Moderate Facial Rosacea
The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate superiority of the Reference and Test products over the Vehicle.
Read the detailed description
Topical azelaic acid is used to treat inflammatory papules and pustules of mild to moderate rosacea. Other topical therapies and oral antibiotics are also used to treat rosacea symptoms. Finacea® (azelaic acid) Foam, 15% contains azelaic acid, a naturally occurring saturated dicarboxylic acid that has proven anti-inflammatory effects, as well as anti-keratinizing and antimicrobial actions.
- Conditions
- Rosacea
- Being tested
- Generic Azelaic Acid Foam, Finacea® (Azelaic Acid) Foam, Vehicle Foam, Cleanser, Sunscreen
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic Azelaic Acid FoamDrug
Topical foam, generic formulation of the brand product.
Finacea® (Azelaic Acid) FoamDrug
Topical foam, brand product.
Vehicle FoamDrug
Topical foam, placebo. Has no active ingredient.
CleanserOther
A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.
SunscreenOther
Sunscreen provided to participants, so they can apply it to their face when outdoors.
TowelOther
A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.
Moisturizing LotionOther
Moisturizing lotion provided to participants, so they can apply it to their face, as needed.
| Study group | Role | What they receive |
|---|---|---|
| Generic Azelaic Acid Foam | Experimental | A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study. Receives: Drug: Generic Azelaic Acid Foam; Other: Cleanser; Other: Sunscreen; Other: Towel; Other: Moisturizing Lotion |
| Finacea® (Azelaic Acid) Foam | Active comparator | A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study. Receives: Drug: Finacea® (Azelaic Acid) Foam; Other: Cleanser; Other: Sunscreen; Other: Towel; Other: Moisturizing Lotion |
| Vehicle Foam | Placebo comparator | A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study. Receives: Drug: Vehicle Foam; Other: Cleanser; Other: Sunscreen; Other: Towel; Other: Moisturizing Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12
All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion >5 mm in diameter.
Measured: Baseline, 12 weeks
Secondary outcomes (1)
Percentage of Participants With Treatment Success Based on IGE Score
Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start19 Jul 2016
- Primary completion22 Jun 2017
- Study completion22 Jun 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 RosaceaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 924 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Teva Pharmaceuticals USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287791
- Sponsor's protocol ID
- ACTA/AZEL/2015
- Status last verified
- Jul 2019
- First submitted
- 14 Sep 2017
- Last updated
- 31 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate Safety and Clinical Equivalence of a Generic Azelaic Acid Foam, 15% and the Reference Listed Finacea® (Azelaic Acid) Foam,15% in Patients With Moderate Facial Rosacea
- ClinicalTrials.gov ID
- NCT03287791
- Acronym / sponsor ID
- ACTA/AZEL/2015
- Conditions
- Rosacea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 924 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Posted 17 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate superiority of the Reference and Test products over the Vehicle.
Detailed description
Topical azelaic acid is used to treat inflammatory papules and pustules of mild to moderate rosacea. Other topical therapies and oral antibiotics are also used to treat rosacea symptoms. Finacea® (azelaic acid) Foam, 15% contains azelaic acid, a naturally occurring saturated dicarboxylic acid that has proven anti-inflammatory effects, as well as anti-keratinizing and antimicrobial actions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Generic Azelaic Acid Foam | Experimental | Drug: Generic Azelaic Acid Foam, Other: Cleanser, Other: Sunscreen, Other: Towel, Other: Moisturizing LotionA thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study. |
| Finacea® (Azelaic Acid) Foam | Active comparator | Drug: Finacea® (Azelaic Acid) Foam, Other: Cleanser, Other: Sunscreen, Other: Towel, Other: Moisturizing LotionA thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study. |
| Vehicle Foam | Placebo comparator | Drug: Vehicle Foam, Other: Cleanser, Other: Sunscreen, Other: Towel, Other: Moisturizing LotionA thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants had to be willing and able to provide written informed consent for the study
- Healthy males or non-pregnant females ≥18 years-of-age with a clinical diagnosis of moderate facial rosacea
- Participants had to have at least 8 and not more than 50 inflammatory facial lesions (that is, papules/pustules) and ≤2 nodules on the face. For the purposes of study treatment and evaluation, these lesions were limited to the facial treatment area including those present on the nose. Lesions involving the eyes and scalp were excluded from the count.
- Participants had to have persistent erythema on the face with moderate (3) score
- Participants had to have a mild (1) to moderate (2) score for telangiectasia on the face
Key exclusion criteria (29 listed)
- Pregnant or lactating or planning to become pregnant during the study period
- Presence of any skin condition on the face that could have interfered with the diagnosis or assessment of rosacea
- Excessive facial hair (for example, beards, sideburns, moustaches) that would interfere could have interfered with diagnosis or assessment of rosacea
- History of hypersensitivity or allergy to azelaic acid, propylene glycol, or any other component of the formulation
- The use within 6 months prior to baseline of oral retinoids (for example, Accutane®) or therapeutic Vitamin A supplements of greater than 10,000 units/day (multivitamins were allowed)
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 |
|---|---|---|
| Generic Azelaic Acid FoamTopical foam, generic formulation of the brand product. | Drug | Generic Azelaic Acid Foam |
| Finacea® (Azelaic Acid) FoamTopical foam, brand product. | Drug | Finacea® (Azelaic Acid) Foam |
| Vehicle FoamTopical foam, placebo. Has no active ingredient. | Drug | Vehicle Foam |
| CleanserA mild cleanser provided to participants, so they can wash their face prior to applying the study drug. | Other | Finacea® (Azelaic Acid) Foam, Generic Azelaic Acid Foam, Vehicle Foam |
| SunscreenSunscreen provided to participants, so they can apply it to their face when outdoors. | Other | Finacea® (Azelaic Acid) Foam, Generic Azelaic Acid Foam, Vehicle Foam |
| TowelA soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug. | Other | Finacea® (Azelaic Acid) Foam, Generic Azelaic Acid Foam, Vehicle Foam |
| Moisturizing LotionMoisturizing lotion provided to participants, so they can apply it to their face, as needed. | Other | Finacea® (Azelaic Acid) Foam, Generic Azelaic Acid Foam, Vehicle Foam |
Primary outcome
Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12
Time frame: Baseline, 12 weeks
All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion >5 mm in diameter.
1 secondary outcome
Percentage of Participants With Treatment Success Based on IGE Score
Time frame: Baseline and 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rosacea
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Teva Pharmaceuticals USA
26 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 Generic Azelaic Acid Foam, Finacea® (Azelaic Acid) Foam and Cleanser in people with Rosacea, run by Actavis Inc. at 26 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 12 inclusion and 29 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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 Jul 2019). 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?
Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12 (time frame: Baseline, 12 weeks). 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 31 Jul 2019.