Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo

NCT01203189

Seborrheic Dermatitis

COMPLETED NA

Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris

NCT03359070

Tinea Cruris

COMPLETED PHASE2

Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis

NCT03289871

Onychomycosis

COMPLETED NA

Safety and Efficacy of Ketoconazole 2% Foam in the Treatment of Pityrosporum Folliculitis

NCT00824863

Pityrosporum Folliculitis

COMPLETED PHASE4

Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer

NCT02679911

Foot Dermatoses

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Seborrheic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Omiganan Topical Gel

Omiganan 1.75%

Group Type EXPERIMENTAL

Omiganan

Intervention Type DRUG

Omiganan Topical Gel

Ketoconazole Topical Cream

Ketoconazole 2.0%

Group Type ACTIVE_COMPARATOR

Ketoconazole

Intervention Type DRUG

Ketoconazole Cream

Vehicle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omiganan

Omiganan Topical Gel

Intervention Type DRUG

Ketoconazole

Ketoconazole Cream

Intervention Type DRUG

Placebo

Vehicle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female subjects with mild to moderate facial SD (IGA 2 or 3), ≥18 years of age, inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than SD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
* Confirmed SD diagnosis by dermatologist
* Significant facial SD affected area as judged by the investigator or medically qualified designee
* Able to participate and willing to give written informed consent and to comply with the study restrictions;
* Willing to refrain from using other SD treatments in the local treatment area
* Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.

Exclusion Criteria

* Any current and / or recurrent clinical significant skin condition other than SD;
* Ongoing use of prohibited SD medication. Washout periods prior to baseline are as follows;

1. Topical steroids, antibiotics, antifungals or other topical (OTC) therapies: 2 weeks
2. Systemic steroids, antibiotics, antifungals or other systemic therapies: 4 weeks;
3. Phototherapy: 3 weeks;
4. Regular use of shampoo for the treatment of PC (including but not limited to OTC zinc pyrithione shampoo), soap for the treatment of seborrheic dermatitis: 2 weeks
5. Changing a soap, method for daily facial and hair washing: 1 week
* Known hypersensitivity to the compounds or excipients of the compounds;
* Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
* Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
* Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;
* Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No