Acne VulgarisPhase 3NCT00031096
Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne
A Phase 3 study testing Azelaic Acid Gel 15% (Finacea, BAY39-6251) in people with Acne Vulgaris, run by LEO Pharma at 16 sites in United States.
Trial summary
Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Azelaic Acid Gel 15% (Finacea, BAY39-6251)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 879 participants
- Where
- 16 sitesUnited States
- Study dates
- Jan 2002to Jul 2002
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be included in the study you MUST have:
- Predominantly facial localization of acne
- Mild to moderate acne vulgaris characterized by the presence of both inflammatory papules and/or pustules, and comedones (whiteheads/blackheads), and of a severity suitable for treatment with topical single therapy.
- a minimum of ten and a maximum of fifty inflammatory papules and/or pustules in the facial area and
- 10 to 100 comedones in the facial area
- no more than 3 small nodules (approx. 5 mm in diameter) in the facial area
Show all 9Show fewer
- Male and female patients
- Age greater or equal to 12 years
- Ability and willingness to accept and comply with the administration of the investigational drugs over 12 weeks and to comply with the required medical examinations (signed informed consent).
Who cannot join
- To be included in the study you MUST NOT have:
- Localization of acne predominantly on the chest and/or the back or confined to the chest and/or the back
- Sandpaper acne with hundreds of small facial comedones
- Moderate or severe acne requiring systemic therapy
- Multitude of small nodules and/or multiple large nodules, cysts, polyporous comedones, draining sinuses e.g. nodulocystic/conglobate acne
- Other skin conditions that might interfere with acne diagnosis and/or evaluation (such as facial psoriasis, seborrheic dermatitis, perioral dermatitis and papulopustular rosacea)
Show all 23Show fewer
- Anticipated or scheduled hospitalization, e.g. for surgery, during the study
- Female patients who have not continuously used their present brand of oral contraceptive (if any) or other hormone therapy for at least 3 months
- Continuous concurrent use of any topical and/or systemic treatment which affects acne
- History of hypersensitivity to any ingredient of the trial drugs
- Concurrent involvement in another investigational study or participation within 30 days prior to the start of this study
- You must not have taken or have had the following types of treatment or therapy prior to being admitted into the study:
- Oral isotretinoin (i.e. Accutane) for 6 months
- Ortho Tri-Cyclen or Estrostep for 3 months
- Oral antibiotics (i.e. tetracyclines, erythromycin) for 4 weeks
- Systemic corticosteroids for 4 weeks
- Systemic non-steroidal anti-inflammatory drugs (NSAIDs) at anti-inflammatory doses for 4 weeks
- Topical (applied to skin) retinoid creams, ointments, gels for 2 weeks
- Topical antibiotics (i.e. tetracyclines, erythromycin, clindamycin) for 2 weeks
- Topical corticosteroids or topical non-steroidal anti-inflammatory (NSAIDs) drugs for 2 weeks
- Topical imidazole antimycotics for 2 weeks
- Topical benzoyl peroxide (BPO) for 2 weeks
- Topical over-the-counter remedies for acne (salicylic acid) for 2 weeks If you have had any of the above, you may still qualify for the study following a washout period (time for your body to completely eliminate, or get rid of, the medication). The study doctor will evaluate whether there is anything else in your history that may affect your safety in the study or interfere with evaluations. He/she may therefore advise you not to participate.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Albuquerque, New Mexico, 87106
Study site
Bay Shore, New York, 11706
Study site
Boulder, Colorado, 80304
Study site
Bryan, Texas, 77802
Study site
Cincinnati, Ohio, 45230
Study site
Hershey, Pennsylvania, 17033
Study site
Knoxville, Tennessee, 37922
Study site
Lexington, Kentucky, 40509
Study site
Mobile, Alabama, 36608
Study site
Newnan, Georgia, 30263
Study site
Portland, Oregon, 97223-6683
Study site
San Antonio, Texas, 78229
Study site
Seattle, Washington, 98105
Study site
Shawnee Mission, Kansas, 66203
Study site
Wichita, Kansas, 67206
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A 12-week, Randomized, Double-blind, Multicenter Study Comparing the Clinical Efficacy and Safety of Azelaic Acid 15% Gel (SH H 655 BA) With Its Vehicle (SH H 655 PBA) in Patients With Mild to Moderate Acne.
Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne.
Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
Read the detailed description
Acne is a common inflammatory skin condition characterized by skin eruptions around hair follicles. People with acne can have pustules (zits or pimples), papules, whiteheads or blackheads, nodules, and redness of the skin. Acne usually involves the face and shoulders, but can also involve the chest, arms, and legs. The purpose of this study is to evaluate the safety and effectiveness of an investigational gel containing active medication compared to the same gel without any active medication (placebo or vehicle) in subjects with mild to moderate facial acne.
This study has initially been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Intendis Inc., a Bayer HealthCare company, is the sponsor of the trial.
- Conditions
- Acne Vulgaris
- Being tested
- Azelaic Acid Gel 15% (Finacea, BAY39-6251), Vehicle gel (SH H 655 PBA)
- Keywords
- Acne Vulgaris, Propionibacterium acnes
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelaic Acid Gel 15% (Finacea, BAY39-6251)Drug
Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.
Vehicle gel (SH H 655 PBA)Drug
Vehicle gel (SH H 655 PBA) applied topically two times per day.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Vehicle gel (SH H 655 PBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The nominal and percent change in lesions counts from baseline to last available visit (end of treatment) and treatment success rates based on Investigator's assessment of mild to moderate acne
Measured: 12 weeks
Secondary outcomes (2)
Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability
Measured: 12 weeks
Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2002 (estimated)
- Study startJan 2002
- Primary completionJul 2002
- Study completionJul 2002
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 879 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031096
- Sponsor's protocol ID
- 90905
- Other IDs
- 304343 (90905), 306100 (91138), 4343
- Status last verified
- Feb 2014
- First submitted
- 21 Feb 2002
- Last updated
- 9 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomized, Double-blind, Multicenter Study Comparing the Clinical Efficacy and Safety of Azelaic Acid 15% Gel (SH H 655 BA) With Its Vehicle (SH H 655 PBA) in Patients With Mild to Moderate Acne.
- ClinicalTrials.gov ID
- NCT00031096
- Acronym / sponsor ID
- 90905
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Propionibacterium acnes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 879 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Jan 2002
- Primary completion
- Jul 2002 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 22 Feb 2002 (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.
Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne.
Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
Detailed description
Acne is a common inflammatory skin condition characterized by skin eruptions around hair follicles. People with acne can have pustules (zits or pimples), papules, whiteheads or blackheads, nodules, and redness of the skin. Acne usually involves the face and shoulders, but can also involve the chest, arms, and legs. The purpose of this study is to evaluate the safety and effectiveness of an investigational gel containing active medication compared to the same gel without any active medication (placebo or vehicle) in subjects with mild to moderate facial acne.
This study has initially been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Intendis Inc., a Bayer HealthCare company, is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251) |
| Arm 2 | Placebo comparator | Drug: Vehicle gel (SH H 655 PBA) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Predominantly facial localization of acne
- Mild to moderate acne vulgaris characterized by the presence of both inflammatory papules and/or pustules, and comedones (whiteheads/blackheads), and of a severity suitable for treatment with topical single therapy.
- a minimum of ten and a maximum of fifty inflammatory papules and/or pustules in the facial area and
- 10 to 100 comedones in the facial area
- no more than 3 small nodules (approx. 5 mm in diameter) in the facial area
Key exclusion criteria (23 listed)
- Localization of acne predominantly on the chest and/or the back or confined to the chest and/or the back
- Sandpaper acne with hundreds of small facial comedones
- Moderate or severe acne requiring systemic therapy
- Multitude of small nodules and/or multiple large nodules, cysts, polyporous comedones, draining sinuses e.g. nodulocystic/conglobate acne
- Other skin conditions that might interfere with acne diagnosis and/or evaluation (such as facial psoriasis, seborrheic dermatitis, perioral dermatitis and papulopustular rosacea)
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 |
|---|---|---|
| Azelaic Acid Gel 15% (Finacea, BAY39-6251)Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day. | Drug | Arm 1 |
| Vehicle gel (SH H 655 PBA)Vehicle gel (SH H 655 PBA) applied topically two times per day. | Drug | Arm 2 |
Primary outcome
The nominal and percent change in lesions counts from baseline to last available visit (end of treatment) and treatment success rates based on Investigator's assessment of mild to moderate acne
Time frame: 12 weeks
2 secondary outcomes
Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability
Time frame: 12 weeks
Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study
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 9 Jun 2023.
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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.
Bayer Study Director study director
Bayer
16 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 Azelaic Acid Gel 15% (Finacea, BAY39-6251) in people with Acne Vulgaris, run by LEO Pharma at 16 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 9 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
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?
The nominal and percent change in lesions counts from baseline to last available visit (end of treatment) and treatment success rates based on Investigator's assessment of mild to moderate acne (time frame: 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 9 Jun 2023.