A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060

NCT01522391 | Completed Phase 1 Results

• 2 other identifiers: DCS-0012007-007103-32
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study was to evaluate microbial density in eczematous lesions during two weeks of twice daily therapy with the investigational product, DPK-060 1% ointment, compared with placebo in patients with atopic dermatitis. This randomized, double-blind, placebo-controlled part of the study was preceded with an open-label investigation in a small group of patients (n=5) treated with two applications of DPK-060 1% ointment per day for four days to assess safety, local tolerability and systemic absorption of DPK-060. The secondary objectives were to evaluate severity of eczema and pruritus, to assess the tolerability and safety of the treatment and to assess the degree of systemic absorption of DPK-060 in blood on Day 7 and Day 21 in a sub-set of 10 patients.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set

  The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

  Baseline and Day 14

• Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set

  The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

  Baseline and Day 14

Secondary Outcomes (26)

• Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set

  Baseline, Day 7 and 21

• Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set

  Baseline, Day 7 and 21

• Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set

  Baseline, Day 7, Day 14 and Day 21

• Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set

  Baseline, Day 7, Day 14 and Day 21

• Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set

  Baseline, Day 7, Day 14 and Day 21

Study Arms (2)

Placebo for DPK-060 ointment

PLACEBO COMPARATOR

Drug: Placebo for DPK-060 ointment

DPK-060 1% ointment

EXPERIMENTAL

Drug: DPK-060 1% ointment

Interventions

DPK-060 1% ointment DRUG

DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2

DPK-060 1% ointment

Placebo for DPK-060 ointment DRUG

Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2

Placebo for DPK-060 ointment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of atopic dermatitis
• Treatable eczematous lesions of a total area of at least 25 cm2 (100 cm2 for the initial five patients)
• Female patients of childbearing potential had to be using an appropriate method of contraception.
• Female patients of childbearing potential were not eligible before PK data from the first 10 patients had been evaluated and the Medical Products Agency (Swedish regulatory agency) had given approval to include women of childbearing potential.

You may not qualify if:

• Significant clinical illness, within the two weeks prior to first dose, which could affect the outcome of the study
• Previous local or systemic antimicrobial therapy within the last four weeks prior to the first application of the investigational product (DPK-060 1% or placebo ointment)
• Existence of any surgical or medical condition which, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug
• Patients who had had systemic treatment for atopic dermatitis 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% or placebo 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 antihistamines 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, were likely to adversely affect the outcome of the 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% or placebo ointment
• Donation of blood, exceeding 450 mL, during the three months prior to first dose
• Participation in a clinical study during the 12 weeks prior to first dose

Sponsors & Collaborators

• DermaGen AB: lead

Study Sites (1)

Quintiles Hermelinen AB

Luleå, Sweden

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Ointments

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Margit Mahlapuu PhD, Assoc. Prof. in Molecular Medicine
• Organization: Pergamum AB

margit.mahlapuu@pergamum.com

+46 70 631 01 09

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 31, 2012
• Study Start: March 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 5, 2018
• Results First Posted: December 5, 2018

Record last verified: 2018-12

Locations

SE (1)