Acne VulgarisPhase 4SKADINCT01387048
Study for Long-term Treatment of Acne Vulgaris With Skinoren Versus Differin
A Phase 4 study testing skinoren and differin in people with Acne Vulgaris, run by University of Magdeburg at 1 site in Germany.
Trial summary
The purpose of this study is to assess the effect of Skinoren® 15% gel compared to no therapy on the maintenance of clinical therapy success in subjects with mild to moderate acne vulgaris previously treated for 3 months by a monotherapy of this substance and to assess the effect of Skinoren® 15% gel, compared to… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- skinoren and differin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Oct 2012
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects between 18 and 45 years of age, inclusive, in good general health.
- Female Subjects of childbearing potential using effective contraceptional methods must have been taking the same type of birth control for at least 6 months prior to entering the study and must not change type of birth control during the study. The subject´s should be willing to perform UPT in decision by physician, if indicated.
- Subjects with mild to moderate acne vulgaris or late-type acne with global facial severity grade 2 through 4 according to the "Investigator´s Static Global Assessment (ISGA)" and B-G (2-7) according to the "Leeds revised acne grading system".
- Subjects with visible microcomedones on the Cyanoacrylate strip taken on the forehead.
- Subjects must read and sign the approved Informed Consent Form (and any local or national authorized requirements )prior to any participation in the study. Subjects must be willing and capable of cooperating to the extent and degree required by the protocol (including refraining from the use of cosmetics and ointments during the course of treatment). Subject must be able to follow all study procedures, attend all schedule visits, and complete the study successfully.
Who cannot join
- Female subjects who are pregnant, trying to become or willing to become pregnant, or who are lactating.
- Subjects who have any clinically relevant finding at their screening physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris (eg, acne conglobata, acne fulminans, secondary-acne or severe nodulocystic acne requiring treatment with oral isotretinoin).
- Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components of the study medication.
- Subjects who are using and not willing to refrain from the following other types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps.
- Subjects who have used topical corticosteroids on the face or systemic corticosteroids within the past 2 weeks.
- Subjects who have used topical antibiotics on the face or systemic antibiotics (only penicillin allowed) within the last 2 weeks.
Show all 13Show fewer
- Subjects who have used topical anti-acne medications within the past 2 weeks.
- Subjects who have used systemic retinoids within the past 6 months.
- Subjects who use medications that are reported to exacerbate acne
- Subjects who are using drugs known to be photosensitizers because of the possibility of increased phototoxicity.
- Subjects who have had a facial procedure performed by an esthetician, beautician, physician, nurse, or other practitioner, within the last 4 weeks.
- Subjects who planned intensive UV exposure during study
- Subjects who participated in another investigational drug or device research study within 30 days of enrollment.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Dermatology and Vereology, Central Hospital Magdeburg
Magdeburg, Saxony-Anhalt, 39120
About this study
Official title: Phase IV An Evaluator-Blind Controlled Parallel-Group Study To Assess Efficacy And Safety Of Skinoren® 15% Gel And Differin® 0,1% Gel For The Treatment And Maintenance Treatment Of Facial Acne Vulgaris And Late-Type Acne In Females
The purpose of this study is to assess the effect of Skinoren® 15% gel compared to no therapy on the maintenance of clinical therapy success in subjects with mild to moderate acne vulgaris previously treated for 3 months by a monotherapy of this substance and to assess the effect of Skinoren® 15% gel, compared to Differin® 0.1% gel on the efficacy and safety during a 9-month long-term treatment period.
Read the detailed description
Differin gel, containing adapalene 0.1%, has been used now for several years in the topical treatment of mild to moderate acne. It has comedolytic and anti-inflammatory activities,and is equally effective and less irritant than other topical retinoids. Adapalene has been shown to maintain therapeutic effect achieved after three months of monotherapy for further three months. Furthermore, its effect in maintenance therapy has been shown in several studies after initial combination with topical or systemic antimicrobials. Skinoren 15% gel (azelaic acid) is an alternative treatment affecting several pathogenetic factors of acne, which has potential in maintenance therapy due to its good tolerability and safety and missing contraindications concerning long-term treatment, which allow even use in pregnancy.
Azelaic acid (AzA; HOOC-(CH2)7-COOH) is a naturally occurring compound that interferes with acne pathogenesis by virtue of its antikeratinizing, antibacterial, and anti-inflammatory properties. Vehicle-controlled studies have verified that AzA exercises a significant and clinically relevant effect on both non-inflammatory and inflammatory acne lesions. In the treatment of moderate to severe acne, 20 percent AzA cream may be favorably combined with minocycline (90 percent good and excellent results), and may contribute towards reducing recurrences following discontinuation of systemic therapy (maintenance therapy with AzA cream). Particular advantages of AzA therapy include its favorable safety and side effect profile. It is non-teratogenic, is not associated with systemic adverse events or photodynamic reactions, exhibits excellent local tolerability, and does not induce resistance in Propionibacterium acnes. The 15 % azelaic acid gel has recently proven efficacy in a maintenance treatment of papulopustular rosacea after a combination treatment with oral doxycycline.
Mild to moderate acne vulgaris is defined as global severity of 2 through 4, according to the Investigator´s Static Global Assessment (ISGA) and Leeds Revised Acne Grading Scale from 2 trough 7.This inclusion criterion corresponds to the clinical grades usually treated with topical anti-acne therapies.
The non-treatment group during the maintenance phase helps to demonstrate the efficacy of Skinoren 15% gel in a maintenance treatment, thereby corroborating the necessity for maintenance therapy reflecting acne as a chronic disease.
Acne lesion counting has been used widely in the evaluation of new acne treatments as a change in facial acne lesions counts over time in an individual patient could reflect a true change. However, lesion counts are more valid in greater patient populations as planned in this study. Therefore, the lesion counts are defined as secondary efficacy criteria except during the maintenance phase for the population treated with azelaic acid. As described before, microcomedones are considered as precursor lesion. Moreover, their counts are constantly reduced during acne treatment and precede the clinical relapse. Therefore, microcomedones counts will be used in this trial as a marker of maintenance of therapeutic effect achieved during initial treatment phase.
- Conditions
- Acne Vulgaris
- Being tested
- skinoren, differin
- Keywords
- acne vulgaris, late-type acne, Skinoren, maintenance
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skinorenDrug
Also called Generikum
gel 15%, twice daily, 36 weeks
differinDrug
Also called Epiduo
0.1% gel, once daily in the evening
skinorenDrug
Also called Generikum
12 weeks treatment, the following 24 months only observation
| Study group | Role | What they receive |
|---|---|---|
| Skinoren gel 15 %, topical | Experimental | primary treatment 12 weeks with Skinoren gel®, followed by maintenance therapy with Skinoren gel® for another 24 weeks, Receives: Drug: skinoren |
| Differin Gel 0.1% | Active comparator | primary 12 weeks therapy with Differin gel®, followed by maintenance therapy with Differin gel® for another 24 weeks. Receives: Drug: differin |
| Skinoren | Experimental | primary 12 weeks therapy with Skinoren gel®, followed by observation only for another 24 weeks, Receives: Drug: skinoren |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of Skinoren 15% Gel
Superiority of Skinoren 15% Gel-group over the observational group in the maintanance phase. Change of Global Severity Grades (ISGA and Leeds)
Measured: 36 weeks
Non-inferiority of Skinoren 15 % gel over the Differin 0.1% gel
Non-inferiority of Skinoren 15% Gel over the current "gold standard" Differin 0.1% gel in the long-term-treatment period: Change of Global severity grades
Measured: 36 weeks
Secondary outcomes (6)
- Change of non-inflammatory, inflammatory and total lesions at all visits.
- Secondary Endpoints:
Microcomedone count changes from week 12-36
Measured: 36 weeks
Change of non-inflammatory, inflammatory and total lesions at all visits
Subjects efficacy assessment
Measured: 36 weeks
change of non-inflammatory, inflammatory and total lesions at all visits
subjects tolerability assessment
Measured: 36 weeks
Change of non-inflammatory, inflammatory and total lesions at all visits
Subjects DLQI assessment
Measured: 36 weeks
change of non-inflammatory, inflammatory and total lesions at all visits
Investigators tolerability assessment
Measured: 36 weeks
change of non-inflammatory, inflammatory and total lesions at all visits
Relapse rate: Number of subjects which lose more than 50% of their initial improvement achieved at maintanance phase
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionOct 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Antje Wiede, University of Magdeburg
- Investigators
- Anja Thielitz, Dr. med., Principal investigator, unfillated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387048
- Sponsor's protocol ID
- BS-HAU-2011
- Other IDs
- 2011-000152-42
- Acronym
- SKADI
- Status last verified
- Jul 2013
- First submitted
- 29 Jun 2011
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV An Evaluator-Blind Controlled Parallel-Group Study To Assess Efficacy And Safety Of Skinoren® 15% Gel And Differin® 0,1% Gel For The Treatment And Maintenance Treatment Of Facial Acne Vulgaris And Late-Type Acne In Females
- ClinicalTrials.gov ID
- NCT01387048
- Acronym / sponsor ID
- SKADI / BS-HAU-2011
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, late-type acne, Skinoren, maintenance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Jul 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.
The purpose of this study is to assess the effect of Skinoren® 15% gel compared to no therapy on the maintenance of clinical therapy success in subjects with mild to moderate acne vulgaris previously treated for 3 months by a monotherapy of this substance and to assess the effect of Skinoren® 15% gel, compared to Differin® 0.1% gel on the efficacy and safety during a 9-month long-term treatment period.
Detailed description
Differin gel, containing adapalene 0.1%, has been used now for several years in the topical treatment of mild to moderate acne. It has comedolytic and anti-inflammatory activities,and is equally effective and less irritant than other topical retinoids. Adapalene has been shown to maintain therapeutic effect achieved after three months of monotherapy for further three months. Furthermore, its effect in maintenance therapy has been shown in several studies after initial combination with topical or systemic antimicrobials. Skinoren 15% gel (azelaic acid) is an alternative treatment affecting several pathogenetic factors of acne, which has potential in maintenance therapy due to its good tolerability and safety and missing contraindications concerning long-term treatment, which allow even use in pregnancy.
Azelaic acid (AzA; HOOC-(CH2)7-COOH) is a naturally occurring compound that interferes with acne pathogenesis by virtue of its antikeratinizing, antibacterial, and anti-inflammatory properties. Vehicle-controlled studies have verified that AzA exercises a significant and clinically relevant effect on both non-inflammatory and inflammatory acne lesions. In the treatment of moderate to severe acne, 20 percent AzA cream may be favorably combined with minocycline (90 percent good and excellent results), and may contribute towards reducing recurrences following discontinuation of systemic therapy (maintenance therapy with AzA cream). Particular advantages of AzA therapy include its favorable safety and side effect profile. It is non-teratogenic, is not associated with systemic adverse events or photodynamic reactions, exhibits excellent local tolerability, and does not induce resistance in Propionibacterium acnes. The 15 % azelaic acid gel has recently proven efficacy in a maintenance treatment of papulopustular rosacea after a combination treatment with oral doxycycline.
Mild to moderate acne vulgaris is defined as global severity of 2 through 4, according to the Investigator´s Static Global Assessment (ISGA) and Leeds Revised Acne Grading Scale from 2 trough 7.This inclusion criterion corresponds to the clinical grades usually treated with topical anti-acne therapies.
The non-treatment group during the maintenance phase helps to demonstrate the efficacy of Skinoren 15% gel in a maintenance treatment, thereby corroborating the necessity for maintenance therapy reflecting acne as a chronic disease.
Acne lesion counting has been used widely in the evaluation of new acne treatments as a change in facial acne lesions counts over time in an individual patient could reflect a true change. However, lesion counts are more valid in greater patient populations as planned in this study. Therefore, the lesion counts are defined as secondary efficacy criteria except during the maintenance phase for the population treated with azelaic acid. As described before, microcomedones are considered as precursor lesion. Moreover, their counts are constantly reduced during acne treatment and precede the clinical relapse. Therefore, microcomedones counts will be used in this trial as a marker of maintenance of therapeutic effect achieved during initial treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Skinoren gel 15 %, topical | Experimental | Drug: skinorenprimary treatment 12 weeks with Skinoren gel®, followed by maintenance therapy with Skinoren gel® for another 24 weeks, |
| Differin Gel 0.1% | Active comparator | Drug: differinprimary 12 weeks therapy with Differin gel®, followed by maintenance therapy with Differin gel® for another 24 weeks. |
| Skinoren | Experimental | Drug: skinorenprimary 12 weeks therapy with Skinoren gel®, followed by observation only for another 24 weeks, |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects between 18 and 45 years of age, inclusive, in good general health.
- Female Subjects of childbearing potential using effective contraceptional methods must have been taking the same type of birth control for at least 6 months prior to entering the study and must not change type of birth control during the study. The subject´s should be willing to perform UPT in decision by physician, if indicated.
- Subjects with mild to moderate acne vulgaris or late-type acne with global facial severity grade 2 through 4 according to the "Investigator´s Static Global Assessment (ISGA)" and B-G (2-7) according to the "Leeds revised acne grading system".
- Subjects with visible microcomedones on the Cyanoacrylate strip taken on the forehead.
- Subjects must read and sign the approved Informed Consent Form (and any local or national authorized requirements )prior to any participation in the study. Subjects must be willing and capable of cooperating to the extent and degree required by the protocol (including refraining from the use of cosmetics and ointments during the course of treatment). Subject must be able to follow all study procedures, attend all schedule visits, and complete the study successfully.
Key exclusion criteria (13 listed)
- Female subjects who are pregnant, trying to become or willing to become pregnant, or who are lactating.
- Subjects who have any clinically relevant finding at their screening physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris (eg, acne conglobata, acne fulminans, secondary-acne or severe nodulocystic acne requiring treatment with oral isotretinoin).
- Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components of the study medication.
- Subjects who are using and not willing to refrain from the following other types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps.
- Subjects who have used topical corticosteroids on the face or systemic corticosteroids within the past 2 weeks.
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 |
|---|---|---|
| skinorenAlso: Generikumgel 15%, twice daily, 36 weeks | Drug | Skinoren gel 15 %, topical |
| differinAlso: Epiduo0.1% gel, once daily in the evening | Drug | Differin Gel 0.1% |
| skinorenAlso: Generikum12 weeks treatment, the following 24 months only observation | Drug | Skinoren |
Primary outcome
Superiority of Skinoren 15% Gel
Time frame: 36 weeks
Superiority of Skinoren 15% Gel-group over the observational group in the maintanance phase. Change of Global Severity Grades (ISGA and Leeds)
Non-inferiority of Skinoren 15 % gel over the Differin 0.1% gel
Time frame: 36 weeks
Non-inferiority of Skinoren 15% Gel over the current "gold standard" Differin 0.1% gel in the long-term-treatment period: Change of Global severity grades
6 secondary outcomes
- Change of non-inflammatory, inflammatory and total lesions at all visits.
Time frame: 36 weeks
Change of non-inflammatory, inflammatory and total lesions at all visits
Time frame: 36 weeks
change of non-inflammatory, inflammatory and total lesions at all visits
Time frame: 36 weeks
Change of non-inflammatory, inflammatory and total lesions at all visits
Time frame: 36 weeks
change of non-inflammatory, inflammatory and total lesions at all visits
Time frame: 36 weeks
change of non-inflammatory, inflammatory and total lesions at all visits
Time frame: 36 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 8 Jul 2013.
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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.
Anja Thielitz, Dr. med. principal investigator
unfillated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing skinoren and differin in people with Acne Vulgaris, run by University of Magdeburg at 1 site in Germany.
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 5 inclusion and 13 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 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Superiority of Skinoren 15% Gel (time frame: 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2013.