THE EFFECT OF AZELAIC ACID ON SYMPTOMS OF ACNE IN FEMALE PATIENTS AGE 20-45 WITH MILD TO MODERATE PAPULOPUSTULAR ACNE (ACNE TARDA)

• Conditions: MILD TO MODERATE PAPULOPUSTULAR ACNE (ACNE TARDA); Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-000416-24-DE
• Lead Sponsor: Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-08
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Female volunteers
-Age 20 - 45
-Acne papulopustulosa of the face (acne tarda)
-ISGA Score 2 (some non-inflammatory lesions, with few inflammatory lesions) or 3 (non-inflammatory lesions predominate, with multiple inflammatory lesions )
-Good general condition and good state of health
-Written informed consent
-Use of a highly effective method of birth control#, if use of a hormonal method, the same drug has to be used since at least 6 month
-Nonsmokers or smokers of maximum 5 cigarettes/day
-BMI between 20 and 28 kg/m²

#: Defined as a method that results in a low failure rate [i.e., less than 1% per year (Pearlindex =1)] when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 53
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Severe form of Acne (ISGA score 4 or higher)
-Other dermatological disorders: rosacea, atopic dermatitis,
perioral dermatitis, psoriasis,
-Previous smoothing or ablative procedures (cryotherapy, fruit acid -/TCA peelings, Fraxel Laser etc.) within the last 3 months
-Participation in a clinical trial within the last 30 days prior Baseline
-Planned absences during scheduled visits or planned or active pregnancy during the course of the study
-Severe acute or chronic diseases
Known allergy or hypersensitivity to the Investigational product orany of the formulation ingredients.
-Current acne treatment with topical or systemic acne therapeutics or treatment as detailed below
-Intake or use of the following medication:
-Systemic Isotretinoin (within the last 6 month prior Baseline)
-Systemic antibiotics (within the last 4 weeks prior Baseline)
-Systemic corticosteroids (within the last 4 weeks prior Baseline)
-Systemic non-steroidal anti-inflammatory drugs in dosage for the treatment of inflammations (within the last 4 weeks prior Baseline)
-Topical retinoids (extensive application over the body or any use on the face within the last 2 weeks prior Baseline)
-Topical corticosteroids (extensive application over the body or any use on the face within the last 2 weeks prior Baseline)
-Topical use of non-steroidal anti-inflammatory drugs for the treatment of inflammations (extensive application over the body or any use on the face within the last 2 weeks prior Baseline)
-Use of self-tanning agents in the face within the last 2 weeks prior Baseline
-Topical acne treatments including over-the-counter preparations and medicated cleansers but excluding cosmetic (make-up) products (within the last 2 weeks prior Baseline)
-Intensive UV-exposition or regular visits of solariums within the last 4 weeks prior Baseline or during the course of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified