Which disease will be treated?

Papulopustular Acne (mild to moderate)

Acne is one of the most common skin diseases. It manifests in the form of oily skin, comedones and inflammatory nodules. The papulopustular acne is an inflammatory acne that leads to superficial papules (red slightly raised nodules) and pustules (blisters that contain white-yellowish pus).

In addition to the comedones there are also inflammatory skin lesions, which make an anti-inflammatory treatment necessary.

TRIAL PHASE: III

DESIGN OF THE TRIAL:

Randomised – Double-blind – Placebo-controlled – Multicenter

Why will this trial be conducted?

In this trial the efficacy and safety of a new gel with 10 mg/g clindamycin and 50 mg/g benzoyl peroxide in comparison with the approved preparation DUAC® Akne Gel and the underlying vehicle in patients with papulopustular acne will be evaluated.

Which treatment arms are given?

Investigational product (Clindamycin/Benzoyl Peroxide Gel (10 mg/g + 50 mg/g)
Comparator DUAC® Akne Gel (Clindamycin/Benzoyl Peroxide Gel (10 mg/g + 50 mg/g)
Gel without active ingredient (Vehicle)

Duration of the trial?

The treatment period is scheduled for 12 weeks with daily application

WHO CAN PARTICIPATE IN THIS TRIAL?

Women, men and adolescents of ≥ 12 years of age:

with the diagnosis of papulopustular acne according to generally accepted criteria
with ≥ 25 non-inflammatory lesions (i.e. open and closed comedones) and ≥ 20 inflammatory lesions (e.g. papules and pustules), thereof ≤ 2 nodular lesions on the face.

For women of childbearing potential:

Application of an efficient contraceptive method during the whole study and a pregnancy test with negative result prior to study start is necessary

WHO CANNOT PARTICIPATE IN THIS TRIAL?

Patients who did not met one of the following criteria:

History or presence of Crohn’s disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis)
Other severe acute or chronic concomitant disease with severe impairment of the general condition
Women with existing or intended pregnancy or during lactation

How many study sites will participate in this study in Germany?

18 sites