Acne is a common inflammatory skin condition characterized by skin eruptions around hair
follicles. People with acne can have pustules (zits or pimples), papules, whiteheads or
blackheads, nodules, and redness of the skin. Acne usually involves the face and shoulders,
but can also involve the chest, arms, and legs. The purpose of this study is to evaluate the
safety and effectiveness of an investigational gel containing active medication compared to
the same gel without any active medication (placebo or vehicle) in subjects with mild to
moderate facial acne.
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer
HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.
Inclusion Criteria:
To be included in the study you MUST have:
- Predominantly facial localization of acne
- Mild to moderate acne vulgaris characterized by the presence of both inflammatory
papules and/or pustules, and comedones (whiteheads/blackheads), and of a severity
suitable for treatment with topical single therapy.
- a minimum of ten and a maximum of fifty inflammatory papules and/or pustules in the
facial area
and
- 10 to 100 comedones in the facial area
- no more than 3 small nodules (approx. 5 mm in diameter) in the facial area
- Male and female patients
- Age greater or equal to 12 years
- Ability and willingness to accept and comply with the administration of the
investigational drugs over 12 weeks and to comply with the required medical
examinations (signed informed consent).
Exclusion Criteria:
To be included in the study you MUST NOT have:
- Localization of acne predominantly on the chest and/or the back or confined to the
chest and/or the back
- Sandpaper acne with hundreds of small facial comedones
- Moderate or severe acne requiring systemic therapy
- Multitude of small nodules and/or multiple large nodules, cysts, polyporous comedones,
draining sinuses e. g. nodulocystic/conglobate acne
- Other skin conditions that might interfere with acne diagnosis and/or evaluation (such
as facial psoriasis, seborrheic dermatitis, perioral dermatitis and papulopustular
rosacea)
- Anticipated or scheduled hospitalization, e. g. for surgery, during the study
- Female patients who have not continuously used their present brand of oral
contraceptive (if any) or other hormone therapy for at least 3 months
- Continuous concurrent use of any topical and/or systemic treatment which affects acne
- History of hypersensitivity to any ingredient of the trial drugs
- Concurrent involvement in another investigational study or participation within 30
days prior to the start of this study
- You must not have taken or have had the following types of treatment or therapy prior
to being admitted into the study:
- Oral isotretinoin (i. e. Accutane®) for 6 months
- Ortho Tri-Cyclen® or Estrostep® for 3 months
- Oral antibiotics (i. e. tetracyclines, erythromycin) for 4 weeks
- Systemic corticosteroids for 4 weeks
- Systemic non-steroidal anti-inflammatory drugs (NSAIDs) at anti-inflammatory doses for
4 weeks
- Topical (applied to skin) retinoid creams, ointments, gels for 2 weeks
- Topical antibiotics (i. e. tetracyclines, erythromycin, clindamycin) for 2 weeks
- Topical corticosteroids or topical non-steroidal anti-inflammatory (NSAIDs) drugs for
2 weeks
- Topical imidazole antimycotics for 2 weeks
- Topical benzoyl peroxide (BPO) for 2 weeks
- Topical over-the-counter remedies for acne (salicylic acid) for 2 weeks
If you have had any of the above, you may still qualify for the study following a washout
period (time for your body to completely eliminate, or get rid of, the medication). The
study doctor will evaluate whether there is anything else in your history that may affect
your safety in the study or interfere with evaluations. He/she may therefore advise you
not to participate.
