Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-004635-29-SE
• Date of registration: 12/09/2007
• Prospective Registration: Yes
• Primary sponsor: Astion Pharma A/S
• Public title: Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301
• Scientific title: Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301
• Date of first enrolment: 07/11/2007
• Target sample size: 140
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004635-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Denmark, Spain, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects will be entered into this study only if they meet all of the following criteria:
1. Subjects of any gender aged from 18 to 85 years.
2. A clinical diagnosis of DLE or SCLE or SLE with chronic CLE lesions defined as:
• A clinically confirmed diagnosis of DLE with sharply demarcated, erythematokeratotic, atrophic or scarring lesions.
• A clinically confirmed diagnosis of SCLE with erythematosus macules, scaly papulosquamous or annular/polycyclic type.
3. One to 5 lesions scoring at least “moderate disease” on the IGA scale.
4. The physical examination without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study.
5. Sexually active females of childbearing potential should either be clinically sterile (post menopausal, undergone hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen for at least 12 weeks prior to the study, during the study and 1 month after the end of the study.
NOTE: For subjects in Germany and Denmark, all females of childbearing potential should either be clinically sterile (post menopausal, undergone hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen for at least 12 weeks prior to the study, during the study and 1 month after the end of the study. Medically accepted contraceptive regimens in these countries are specified as:
systemic contraceptive (oral, implant, injection).
diaphragm or cervical cap with intravaginal spermicide.
intrauterine device.
condom with intravaginal spermicide.
6. Willing and able to comply with the study procedures.
7. Prepared to grant authorised persons access to medical records.
8. Signed informed consent.

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:
Subjects will be entered into this study only if they meet none of the following criteria:
1. Active skin disease other than DLE or SCLE or SLE with chronic CLE lesions in the tested areas, including acute CLE.
2. Concomitant, or within 4 weeks prior to dosing, treatment with local corticosteroids, immune modulators, or any other topical lupus erythematosus products.
3. Unstable use of systemic products for their lupus erythematosus.
4. Concomitant treatment with drugs with a known photosensitising potential e.g. tetracyclines, griseofulvin, sulfonamides, thiazides, furosemide and tolbutamide.
5. Concomitant, or within 4 weeks prior to dosing, treatment with medicinal products containing salbutamol.
6. Previous participation in an ASF-1096 study.
7. Symptoms of a clinically significant illness or behaviour that may influence the outcome of the study in the 4 weeks before the study and during the study.
8. Participation in another clinical study, including the 4 week period preceding the study.
9. Known allergic reactions to components of the study preparations.
10. Pregnancy (according to pregnancy test) or nursing.
11. Other factors which may affect participation such as mental or legal incapacitation, drug or alcohol abuse within the last 2 years, or in the investigator’s opinion, subjects who may not be capable of following the study schedule for any reason.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) symptoms of the skin can be included in this study. Those patients who have a diagnosis of Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions of the skin can also be included in the study.

Intervention(s)

Product Name: ASF-1096 Cream 0.25%
Pharmaceutical Form: Cream
INN or Proposed INN: R-salbutamol sulphate
Current Sponsor code: ASF-1096
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use

Product Name: ASF-1096 Cream 0.5%
Pharmaceutical Form: Cream
INN or Proposed INN: R-salbutamol sulphate
Current Sponsor code: ASF-1096
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use

Product Name: ASF-1096 Cream 1.0%
Pharmaceutical Form: Cream
INN or Proposed INN: R-salbutamol sulphate
Current Sponsor code: ASF-1096
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use

Primary Outcome(s)

Secondary Objective: The secondary objectives of the study are:
• To compare responders over time.
• To compare responders based on IGA over time.
• To compare the treatment effect of ASF-1096 0.25%, 0.5% and 1% cream to placebo, and also between ASF-1096 0.25%, 0.5% and 1% concentrations, with respect to change from baseline for the summed reduced CLASI (RCLASI score, as well for each of the elements (erythema, scaling/hyperkeratosis, oedema/infiltration and subcutaneous nodules/plaque) in the RCLASI score.
• To compare the four treatment groups with regards to the change from baseline in Patient Global Assessment (PGA) of status during the treatment period as well as subjects' assessment of itching and pain on a visual analogue scale (VAS).
• To determine the impact of the disease on Quality of Life (QoL) as determined by the Dermatological Life Quality Index (DLQI), a validated questionnaire for dermatological subjects.
• To evaluate the safety aspects for the body as a whole.

Primary end point(s): The percentage of responders on each treatment will be the primary endpoint. The IGA will be used as the efficacy parameter. Each chosen lesion (1 to maximally 5 lesions with active disease) will be assessed separately. The values will be added up and a mean score for the subject status calculated.
Response is defined as either: a mean IGA score of 0 at Visit 6 (after 8 weeks of treatment), or
-For treatment-resistant subjects (i.e subjects on systemic treatment): an improvement from baseline to Visit 6 (after 8 weeks of treatment) of at least 1 point in the mean IGA score (i.e. a decrease in score of =1 point), or
-For subjects without systemic tratment: an improvement from baseline at Visit 6 (after 8 weeks of treatment) of at least 2 points in the mean IGA score (i.e. a decrease in score of =2 points).

Main Objective: The primary objective is to compare the treatment effect of ASF-1096 0.25%, 0.5% and 1% cream to placebo cream, and also between ASF-1096 0.25%, 0.5% and 1% concentrations, with respect to the percentage of responders based on the IGA scoring after 8 weeks of treatment.

Secondary ID(s)

ASF-1096-301