A randomized, double blinded placebo controlled study to investigate antimicrobial efficacy and safety following topical application of DPK-060. Final protocol dated 2007-12-19. CRO protocol no. Q-27318. Final protocol incorporating amendment 1 dated 2008-08-28. Amendment 2 dated 2008-10-01.

• Conditions: Atopic dermatitis

• Registration Number: EUCTR2007-007103-32-SE
• Lead Sponsor: DermaGen AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Part A
•Fulfilling the diagnostic criteria of Williams (Williams, 1994a, 1994b, 1994c, 1996) for AD (disease involvement must similarly affect the flexor regions of both arms/legs/shoulder)
•For inclusion in Part A of the study, patients must have treatable eczematous lesions of a total area of at least 100 cm2
•Outpatients aged between 18 and 65 years inclusive. Females must use an accepted form of contraception such as a stable dose of oral contraceptive or a hormone implant for at least three months prior to dosing or barrier methods (i.e. intrauterine device, diaphragm, combination of a condom and spermicide) for the duration of the trial
•No clinically important abnormal physical findings at the screening examination as judged by medical history, physical examination, ECG, vital signs, hematology, clinical chemistry
•Has been given written and verbal information and has had opportunity to ask questions about the study
•Signed consent (written) to participate in the study
Part B
•Fulfilling the diagnostic criteria of AD
•For inclusion in Part B of the study, patients must have treatable eczematous lesions of a total area of at least 25 cm2.
•Outpatients aged between 18 and 65 years inclusive. Before the PK data from the first set of 10 patients have been evaluated fertile females will not be eligible. Thereafter if approved by the MPA fertile females may be included and must use an accepted form of contraception such as a stable dose of oral contraceptive or a hormone implant for at least three months prior to dosing or barrier methods (i.e. intrauterine device, diaphragm, combination of a condom and spermicide) for the duration of the trial. Pending the MPA decision, patients (excluding fertile females) will continuously be recruited into the study and PK samples will be collected. Non-fertile females must fulfill one of following:
- Amenorrhea and no pregnancy in the last 12 months prior to enrolment combined with FSH levels in the postmenopausal range, as judged by the investigator
-Documentation of being irreversible surgically sterile, i.e. hysterectomy or bilateral oophorectomy (but not tubal ligation)
•No clinically important abnormal physical findings at the screening examination as judged by the investigator
•Has been given written and verbal information and has had opportunity to ask questions about the study
•Signed consent (written) to participate in the study

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded if any of the following criteria are present:
•Significant clinical illness, within the 2 weeks prior to first dose, which could affect the outcome of the study
•Previous local or systemic antimicrobial therapy within the last 4 weeks prior to the first application of the investigational product (DPK-060 1% ointment)
•Existence of any surgical or medical condition which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug
•Patients who have had systemic treatment for AD or other topical or transdermal treatments (such as nicotine, hormone replacement therapies) on the site of eczema within 14 days prior to first application of DPK-060 1% ointment and/or topical treatment with tar, any corticosteroid, topical immunomodulators or oral treatment with any corticosteroids within 14 days prior to first application and/or oral anti-histamines within 14 days of the first dose.
•A need for any other medication during the period 0 to 7 days before entry to the study, (excluding the oral contraceptive pill for females) except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study
•Diagnosis of other skin diseases, which in the opinion of the investigator, are likely to adversely affect the outcome of study
•History or evidence of significant cardiac, renal, hepatic or endocrine disease
•Significant hypersensitivity or allergy, as judged by the investigator
•Immunocompromised patients
•Lice or scabies
•Tinea corporis
•Hypersensitivity to the ingredients of the vehicle
•The presence of prominent tattoos at sites of application of DPK-060 1% ointment
•Donation of blood, exceeding 450 ml, during the 3 months prior to first dose
•Participation in a clinical study during the 12 weeks prior to first dose
•Ongoing alcohol or drug abuse
•Positive pregnancy test or lactation

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary endpoint will be an evaluation of microbial density (microbial colony forming units/cm2). ;Main Objective: The primary objective is:<br>•To evaluate microbial density (microbial colony forming units/cm2) in eczematous lesions during 2 weeks of twice daily therapy with the study product, DPK-060 1% ointment, compared with placebo <br>;Secondary Objective: The secondary objectives are:<br>•to evaluate severity of eczema and pruritus<br>•to assess the tolerability and safety of the treatment<br>•to assess the degree of absorption of DPK-060 in blood in a subset of 10 patients<br>