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

• Conditions: Seborrhoeic dermatitis; MedDRA version: 9.1Level: LLTClassification code 10012488Term: Dermatitis seborrheic

• Registration Number: EUCTR2007-004649-14-FI
• Lead Sponsor: Astion Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

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