Trial Description - Universitätsklinikum Freiburg

DRKS-ID: DRKS00003170
Date of Registration in DRKS: 2011/07/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Trial Description
Title
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
Trial Acronym
[---]*
URL of the trial
[---]*
Brief Summary in Lay Language
Acne vulgaris (acne) is a common condition that occurs mostly in adolescence and
young adulthood, and by others hormonally induced changes in the sebaceous
follicles of the skin caused. The often chronic course of illness over many years
often leads to negative effects on psychosocial development and an impaired
quality of life. This requires the use of drugs that are also in the long term
treatment safe and effective. Occur inflammatory or non-inflammatory lesions
(papules, pustules and blackheads) on. The choice of an acne treatment depends
on the type and severity of acne. For slight to moderate acne preferably an
external medical treatment is provided. Azelaic acid (Skinoren) is an alternative to
retinoids treatment. It is suitable for maintenance treatment, since it is well
tolerated and has no contraindications regarding long-term use and can thus also
be used during pregnancy. The selected age group of 18-45 years (60 patients)
per se is already characterized by a higher number of Late-typ acne who need a
safe and effective long-term therapy.
Brief Summary in Scientific Language
1. Hypothesis: superiority of Skinoren 15% gel compared to observation in the
maintenance phase: Modification of the inflammatory acne lesions by 12-36 weeks
in all patients in the phase of therapy with Skinoren 15% Gel ® treated.
2.Hypothesis: Non-inferiority of Skinoren 15% gel compared with Differin Gel 1%
in the long-term therapy: modification of the general severity according to the
"Revised Leeds acne grading system" at all visits
Organizational Data
DRKS-ID: DRKS00003170
Date of Registration in DRKS: 2011/07/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
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DRKS-ID: DRKS00003170
Date of Registration in DRKS: 2011/07/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
DRKS-ID: DRKS00003170
Date of Registration in DRKS: 2011/07/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: 66/11 , Ethikkommission der Medizinischen Fakultät
der Otto-von-Guericke-Universität Magdeburg
Secondary IDs
Universal Trial Number (UTN): U1111-1122-5234
EudraCT-No.
(for studies acc. to Drug Law): 2011-000152-42
BfArM-No.: 4037374
Health condition or Problem studied
ICD10: L70.9 - Acne, unspecified
Interventions/Observational Groups
Arm 1: 12 weeks of treatment with Skinoren ® 15% Gel (Azelaic acid) 2 times
daily (morning and evening) followed by maintenance therapy with Skinoren
Gel ® 15% for an additional 24 weeks
Arm 2: 12 weeks of treatment with Skinoren ® 15% Gel (azelaic acid) two times
daily (moning and evening) followed by pure follow-up without therapy for an
additional 24 weeks
Arm 3: 12 weeks of treatment with Differin ® Gel 0.1% (Adapalene), 1 time daily
in the evening followed by maintenance treatment with Differin ® Gel 0.1% for
an additional 24 weeks
Characteristics
Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: [---]*
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DRKS-ID: DRKS00003170
Date of Registration in DRKS: 2011/07/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: [---]*
Who is blinded: investigator/therapist
Control: Active control
Purpose: Treatment
Assignment: Parallel
Phase: IV
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): No
Primary Outcome
mild to moderate acne vulgaris, or late-type acne on the face, is in accordance
with the general severity of acne, according to the "Investigator's Static Global
Assessment (ISGA)" (Grade 2-4) visually by the investigator or the "Revised Leeds
Acne Grading Scale" Photo by (Grade 2-7) in all visits assessed
Secondary Outcome
1. Change in non-inflammatory lesions (open and closed comedones), the
inflammatory (papules, pustules, nodules) and total lesions at all visits.
2.Change in the global severity at all visits after ISGA.
3.Change the Mikrokomedonenanzahl in all groups at all visits.
4.General assessment of the efficacy and tolerability of the drugs on the basis of
compatibility scores by investigator and patient at all visits and a quality of life
questionnaire at selected visits by the patient
5. Determination of relapse rates in all groups, ie the patient, the 50% of their
initial treatment success lose again in the maintenance treatment phase
Countries of recruitment
DE Germany
Locations of Recruitment
Recruitment
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DRKS-ID: DRKS00003170
Date of Registration in DRKS: 2011/07/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2011/08/12
Target Sample Size: 60
Monocenter/Multicenter trial: Monocenter trial
National/International: National
Inclusion Criteria
Gender: Female
Minimum Age: 18 Years
Maximum Age: 45 Years
Additional Inclusion Criteria
1.General good health condition,
2. mild to moderate acne vulgaris, or late-type acne on the face, according to the
general severity of acne, according to the "Investigator's Static Global Assessment
(ISGA)" (2-4) or the "Revised Leeds Acne Grading Scale" (2-7) ,
3. In this study, only to be women (ages 18 to 45 years) were included for several
reasons
4. visible on the number of microcomedones cyanoacrylate smear on their
foreheads,
5. Patient's signature on the consent form and privacy statement
6. Willingness of patients to adhere to the prescribed study instructions.
Exclusion criteria
1.
Female subjects who are pregnant, trying to become or willing to become
pregnant, or who are lactating.
2.
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).
3.
Subjects who have a known hypersensitivity or previous allergic reaction to
any of the active components of the study medication.
4.
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 containing BPO, sulfacetamide
sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain
retinol, salicylic acid, or α- or ß-hydroxy acids.
5.
Subjects who have used topical corticosteroids on the face or systemic
corticosteroids within the past 2 weeks. Use of inhaled, intra-articular or intralesional (other than for facial acne lesions) steroids is acceptable.
6.
Subjects who have used topical antibiotics on the face or systemic
antibiotics (only penicillin allowed) within the last 2 weeks, respectively.
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DRKS-ID: DRKS00003170
Date of Registration in DRKS: 2011/07/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
7.Subjects who have used topical anti-acne medications (eg, BPO, retinoids,
salicylates, glycolic acid) within the past 2 weeks.
8.Subjects who have used systemic retinoids within the past 6 months.
9.Subjects who use medications that are reported to exacerbate acne (eg, mega
dose of certain vitamins B2, B6, and B12, haloperidol, halogens such iodide and
Addresses
Primary Sponsor
Universitätsklinikum Magdeburg
Dekan
Mr. Prof. Dr. med. Hermann-Josef Rothkötter
Leipziger Str. 44
39120 Magdeburg
Germany
Telephone: +49-391-67-15750
Fax: +49-391-67-15749
E-mail: hermann-josef.rothkoetter at med.ovgu.de
URL: [---]*
Contact for Scientific Queries
Universitätsklinikum Magdeburg
Klinik für Dermatologie und Venerologie
Ms. Dr. med. Anja Thielitz
Leipziger Str. 44
39120 Magdeburg
Germany
Telephone: +49-391-6715428
Fax: +49-391-6715265
E-mail: anja.thielitz at med.ovgu.de
Page 5 of 7
DRKS-ID: DRKS00003170
Date of Registration in DRKS: 2011/07/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Contact for Scientific Queries
Universitätsklinikum Magdeburg
Klinik für Dermatologie und Venerologie
Ms. Dr. med. Anja Thielitz
Leipziger Str. 44
39120 Magdeburg
Germany
Telephone: +49-391-6715428
Fax: +49-391-6715265
E-mail: anja.thielitz at med.ovgu.de
URL: [---]*
Contact for Public Queries
Universitätsklinikum Magdeburg
Klinik für Dermatologie und Venerologie
Ms. Dr. med. Anja Thielitz
Leipziger Str. 44
39120 Magdeburg
Germany
Telephone: +49-391-67-15428
Fax: +49-391-67-15265
E-mail: anja.thielitz at med.ovgu.de
URL: [---]*
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
Intendis GmbH
Max-Dohrn-Str. 10
10589 Berlin
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Status
Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2012/10/15
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DRKS-ID: DRKS00003170
Date of Registration in DRKS: 2011/07/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Trial Publications, Results and other documents
Further trial documents deutscher Abschlussbericht zur Klinischen Prüfung SKADI
Paper Publikation JEADV 2014
* This entry means the parameter is not applicable or has not been set.
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