Safety of ASF 1057 cream 0.5% under long term use in the treatment of seborrhoeic dermatitis: A 12 month open label extension multi-centre phase III trial

Astion Pharma A/S0 个研究点目标入组 300 人开始时间: 2007年12月3日最近更新: 2012年3月19日

研究概览

暂无简介。

•1. Signed and dated informed consent,
•2. Completion of Trial ASF 1057 301 as documented on the End of Trial status page in the case report form (CRF).
•3. Sexually active females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a medically accepted contraceptive method (and agree to use it during the trial) such as:
•- Systemic contraceptive (oral, implant, injection),
•- Diaphragm or cervical cap with intravaginal spermicide,
•- Intrauterine device, or
•- Condom with intravaginal spermicide.
•In Denmark and Germany, the patients must agree to continue their contraception during the trial and for 1 month after the end of the trial.
•4. Willingness and ability to comply with the trial procedures.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Female patients who are pregnant or breast-feeding,
•2. Known allergy to any of the constituents of the product being tested,
•3. Known immunosuppressive (e.g., AIDS/HIV) or neurological diseases (e.g., Parkinson or MS),
•4. Presence of an other serious or progressive disease which, according to the Investigator may interfere with treatment outcome,
•5. Active skin disease such as psoriasis, atopic dermatitis, rosacea, lupus erythematosus, or other inflammatory or infectious skin disease which, according to the Investigator may interfere with treatment outcome,
•6. Intention to use topical medical treatment in the area to be treated within the next 12 months, e.g., anti inflammatory (e.g., corticosteroids, non-steroidal anti inflammatory drugs [NSAIDs]), coal tar preparations, anti-seborrhoeic preparations, antihistamines, antibiotics, or antifungal medications,
•7. Intention to use of other topical pharmaceutical products on the area to be treated during treatment period.

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