check_circleStudy Completed

Acne Vulgaris

Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne

Trial purpose

Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne.

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 doctor's office for up to 5 visits.

Key Participants Requirements

Sex

Both

Age

12 Years
  • 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 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.

Trial summary

Enrollment Goal
879
Trial Dates
January 2002 - July 2002
Phase
Phase 3
Could I Receive a placebo
No
Products
Finacea (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Dermatology Clinical Research CenterSan Antonio, 78229, United States
Completed
Central Kentucky Research Associates, Inc.Lexington, 40509, United States
Completed
PMG Research of Winston-Salem, Inc.Winston-Salem, 27103, United States
Completed
Boulder Medical CenterBoulder, 80304, United States
Completed
J & S Studies, Inc.Byran, 77802, United States
Completed
Seattle Women's: Health, Research, GynecologySeattle, 98105, United States
Completed
Meda Phase Inc.Newnan, 30263, United States
Completed
Dermatology Research Associates, Inc.Cincinnati, 45230, United States
Completed
Oregon Medical Research CenterPortland, 97223-6683, United States
Completed
Compliant Clinical Research, Inc.Wichita, 67206, United States
Completed
Coastal Clinical Research, IncMobile, 36608, United States
Completed
Medical & Clinical Research AssociatesBayshore, 11706, United States
Completed
Compliant Clinical Research, Inc.Shawnee, 66203, United States
Completed
Dermatology Associates of KnoxvilleKnoxville, 37922, United States
Completed
Pennsylvania State University College of MedicineHershey, 17033, United States
Completed
Academic Dermatology AssociatesAlbuquerque, 87106, United States

Primary Outcome

  • The nominal and percent change in lesions counts from baseline to last available visit (end of treatment) and treatment success rates based on Investigator's assessment of mild to moderate acne
    date_rangeTime Frame:
    12 weeks
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    Safety Issue:
    No

Secondary Outcome

  • Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A 12-week, Randomized, Double-blind, Multicenter Study Comparing the Clinical Efficacy and Safety of Azelaic Acid 15% Gel (SH H 655 BA) With Its Vehicle (SH H 655 PBA) in Patients With Mild to Moderate Acne.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2