Trial document




drksid header

  DRKS00003170

Trial Description

start of 1:1-Block title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003170
  •   2011/07/20
  •   [---]*
  •   yes
  •   Approved
  •   66/11, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1122-5234 
  •   2011-000152-42 
  •   4037374 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   L70.9 -  Acne, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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
  •   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
  •   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
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/08/12
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   45   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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 intra-lesional (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.

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 bromide, lithium etc.)

10. Subjects who are using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.

11. Subjects who have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the last 4 weeks.

12. Subjects who planned intensive UV exposure during study (mountain sports, UV irradiation, sunbathing, etc.)

13. Subjects who participated in another investigational drug or device research study within 30 days of enrolment.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Magdeburg Dekan
    • Mr.  Prof. Dr. med.  Hermann-Josef  Rothkötter 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Magdeburg Klinik für Dermatologie und Venerologie
    • Ms.  Dr. med.  Anja   Thielitz 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Magdeburg Klinik für Dermatologie und Venerologie
    • Ms.  Dr. med.  Anja  Thielitz 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Intendis GmbH
    • Max-Dohrn-Str. 10
    • 10589  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/10/15
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.