Study for Long-term Treatment of Acne Vulgaris With Skinoren Versus Differin

NCT01387048 | Completed Phase 4 DMC

• 2 other identifiers: BS-HAU-20112011-000152-42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 Differin® 0.1% gel on the efficacy and safety during a 9-month long-term treatment period.

Conditions

Acne Vulgaris

Keywords

acne vulgaris; late-type acne; Skinoren; maintenance

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  36 weeks

Secondary Outcomes (6)

• - Change of non-inflammatory, inflammatory and total lesions at all visits.

  36 weeks

• Change of non-inflammatory, inflammatory and total lesions at all visits

  36 weeks

• change of non-inflammatory, inflammatory and total lesions at all visits

  36 weeks

• Change of non-inflammatory, inflammatory and total lesions at all visits

  36 weeks

• change of non-inflammatory, inflammatory and total lesions at all visits

  36 weeks

Study Arms (3)

Skinoren gel 15 %, topical

EXPERIMENTAL

primary treatment 12 weeks with Skinoren gel®, followed by maintenance therapy with Skinoren gel® for another 24 weeks,

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.

Drug: differin

Skinoren

EXPERIMENTAL

primary 12 weeks therapy with Skinoren gel®, followed by observation only for another 24 weeks,

Drug: skinoren

Interventions

skinoren DRUG

gel 15%, twice daily, 36 weeks

Also known as: Generikum

Skinoren gel 15 %, topical

differin DRUG

0.1% gel, once daily in the evening

Also known as: Epiduo

Differin Gel 0.1%

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Magdeburg: lead
• Bayer: collaborator

Study Sites (1)

Clinic for Dermatology and Vereology, Central Hospital Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

azelaic acid; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzoyl Peroxide; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Anja Thielitz, Dr. med.

  unfillated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. nat.

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 4, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

DE (1)