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Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne. Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne. Clinical research trials and Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne. medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne.. Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne. Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne. clinical trial. Participants frequently get the best healthcare available for their Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne. condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne.  Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne.
Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne.
For Condition: Acne
Status: Completed
Sponsor(s): Berlex Laboratories ,
Synopsis: 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.
Details: Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctorÂ’s office for up to 5 visits.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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). 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 papulo-pustular 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 corticosteriods 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.
Total Enrollment: 800
Location and Contact Information:
Additional Information:
Study ID Numbers: 304343 / 306100; 4343
Study Start Date: January 2002
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031096
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Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in subjects with mild to moderate acne.
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