Seborrhoeic dermatitis
Conditions
Interventions
Product Name: ASF-1057-Cream 0.5%
Pharmaceutical Form: Cream
INN or Proposed INN: Glyceryl monocaprylate
Current Sponsor code: ASF-1057
Concentration unit: % (W/W) percent weight/weight
Concentration
Sponsors
Astion Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To document the safety profile of ASF 1057 cream 0.5% when used for up to 12 months in the treatment of seborrhoeic dermatitis patients. ;Secondary Objective: - To describe number of patient discontinuations and the reasons for discontinuations, – To determine exposure time to ASF 1057 cream 0.5% per patient, – To determine the frequency of treatment courses (i.e., 3 weeks of treatment with ASF 1057 cream 0.5%, will be counted per eligible location of occurrence) of seborrhoeic dermatitis symptoms during long term use of ASF 1057, – To determine the proportion of successful treatment courses (the entire area to be treated has responded to treatment, i.e., OSS = 1 score units) on the face, – To determine the proportion of successful treatment courses on the chest and upper back, – To measure the effect of ASF 1057 on recurring seborrhoeic dermatitis symptoms over time as determined by OSS and Dermatology Life Quality Index (DLQI). ;Primary end point(s): Incidence and severity of AEs and adverse drug reactions (ADRs). | — |
Countries
Finland, France
Outcome results
None listed