A phase 2, randomized, vehicle and ketoconazole-controlled, evaluator-blinded, study to explore the efficacy, pharmacodynamics and safety of omiganan 1.75% topical gel BID in patients with mild to moderate facial seborrheic dermatitis.

Seborrheic dermatitis (SD) is a common dermatological condition which involves
erythema, scaling/flaking and pruritus. It affects mainly seborrheic
anatomical sites of the face, retro-auricle area and the upper chest. When
present on the scalp SD is distinctly considered separately as a
non-inflammatory variant of SD, pityriasis capitis (PC). In infants, the
incidence can be up to 42%. In adolescents and adults the incidence is 1% to
3% of the general population. Treatment modalities are mainly topical and
include anti-fungals, topical steroids and immunomodulatory therapies. Despite
this, the burden of disease is considered to be high (Borda LJ and
Wikramanayake TC, 2015. Berk T and Scheinfeld N 2010).

The pathogenesis of SD is not completely understood. Studies have identified
several factors, including fungal colonization (in particular with yeasts of
the genus Malassezia), sebaceous gland activity and host factors (Borda LJ and
Wikramanayake TC, 2015). Recently interactions between the host and
microorganisms have been reported, with bacteria having a strong association
with severity of PC. The relationship between Staphylococcus and
Propionibacterium were mutual inhibitory. The microbiome in PC is characterized
by a preponderance of Staphylococcus and lesser diversity compared to normal
scalp (Xu Z, 2016).

Primary Objective
* To explore the efficacy and pharmacodynamic effects of omiganan topical gel
in facial seborrheic dermatitis
Secondary Objectives
* To explore skin and faecal microbiome in patients with seborrheic dermatitis
* To evaluate the safety and tolerability of omiganan topical gel in facial
seborrheic dermatitis

A phase 2, randomized, vehicle and ketoconazole-controlled, evaluator-blinded
study to explore the efficacy, pharmacodynamics and safety of omiganan 1.75%
topical gel BID in patients with mild to moderate facial seborrheic dermatitis.

CLS001 is a topical gel containing omiganan, a 12-amino-acid cationic peptide.
A previous phase 2 drug study in atopic dermatitis patients studied dosage of 1
and 2.5 % QD with a maximum treated body surface of 1%, whereas this phase II
study will dose 1.75% BID. The maximum treated body surface area will be
approximately 5% (face).

The maximum dose of topical omiganan is estimated at: 905 cm2 (5% total average
BSA of an adult with a total body surface area of 1.81 m2) x 0.44 mg/cm2
(average amount applied per cm2) x 0.0175 (dose of 1.75% w/w) x 2 (BID) = 14 mg
per day.

The risks associated with the topical administration of CLS001 to humans has
been identified in over 4,000 subjects in total in twenty six clinical trials
completed with topical applications of omiganan in formulations ranging from
0.5% to 3% in an aqueous gel and from 1% to 5% in an alcoholic solution for the
indications of various indications including treatment of the inflammatory
lesions of rosacea, treatment of acne, treatment of atopic dermatitis and
treatment of S. aureus in the nasal carriage. Omiganan when applied topically
to intact or abraded skin, intranasally or at peripheral and central venous
catheter sites appears to be safe and well tolerated. In addition, omiganan was
only rarely detected in the plasma of subjects after topical application to
intact or abraded skin, to the nasal mucosa or at peripheral catheter sites.
The risk of topical application to a very restricted lesional area can be
considered minimal. Potential beneficial effects on seborrheic dermatitis are
to be explored in this study. Therefore, providing the protocol is adhered to,
careful observation and medical management will minimize any associated risk in
this study.