Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pilaris, a Prospective Study

Keratosis pilaris (KP) is a benign, inherited skin disorder that presents as grouped, rough,
horny follicular papules. It is estimated that 40-50% of the adult population and 50-80% of
adolescents suffer from KP. Both men and women are affected, with a possible female
predominance. It is noted worldwide and shows no racial predilection. Most patients with KP
are actually unaware that the condition has a designed medical term. Although no clear
etiology had been identified, KP is sometimes associated with other skin conditions such as
icththyosis vulgaris, xerosis or atopic dermatitis.

Many patients with KP never seek medical attention since they are asymptomatic. However, KP
can create significant cosmetic concerns in some cases. It can also become symptomatic
especially when inflammatory lesions are present. There is no gold standard treatment for KP.
Prevention of excessive dryness of the skin and continued moisturization are used currently
as standard of care. Many topical agents such as tretinoin, ammonium lactate lotion, urea
creams, tazarotene, adapalene, tacrolimus, alpha hydroxy acids and salicylic acids have been
used with variable results. Sometimes topical corticosteroids are used, especially when
inflammation is present. In general, KP treatments need to be continuous and complete
clearance may not be possible.

Salkera emollient foam is a keratolytic foam containing 6% salicylic acid in an aqueous based
emollient foam vehicle. It is different from other salicylic containing topical product in
that it has been shown to produce desquamation of the stratum corneum while not effecting
qualitative or quantitative changes in the structure of the viable dermis. In addition, it
also contains aloe vera and anti-oxidants which help to sooth the skin. Salkera emollient
foam has been used to treat several hyperkeratotic skin disorders such as KP, psoriasis,
keratosis palmaris/plantaris, verrucae, icthyoses and pityriasis rubra pilaris. However,
there has been no published study assessing the efficacy and safety of Salkera emollient foam
in treating moderate to severe KP.

This prospective single center pilot study is designed to assess the efficacy and safety of
Salkera emollient foam in treating moderate to severe KP. Patients' cosmetic acceptance of
the product will also be assessed. In addition, this study is also designed to develop a
validated outcome measure for assessing KP severity that can be used in future KP clinical
trials.

Inclusion Criteria:

- Subject is willing and able to give informed consent.

- Subject is willing and able to participate in the study as an outpatient and is
willing to comply with the study requirements.

- Subject is 18 years of age or older.

- Subject has KP on 2 out of the 4 extremities.

- For each assessed extremity, subject has at least a moderate severity (≥ 3) on the
Investigator Site Assessment of KP Severity.

- For each assessed extremity, subject has an aggregate score of at least 6 on the
Investigator Assessment of Erythema, Roughness and Scaling.

- If subject is a female of childbearing potential, subject will have a negative urine
pregnancy test at screening (week 0).

- If female, subject will be either post-menopausal for > 2 year, surgically sterile
(hysterectomy or bilateral tubal ligation), or practicing one form of birth control
(abstinence, oral contraceptive, estrogen patch, implant contraception, injectable
contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner).
Female subjects should continue to practice birth control for 1 month after the
completion of study.

Exclusion Criteria:

- Subject has evidence of a clinically significant, unstable or poorly controlled
medical condition as determined by the investigators/sub-investigators.

- Subject has active skin infection, atopic dermatitis or any other skin disease that
will interfere with the clinical assessment of KP.

- Subject has known allergies to any ingredient of study medication.

- Subject who has used any of the following topical therapies for KP lesions within the
last two weeks: topical corticosteroid, tretinoin, tazarotene, adapalene, salicylic
acid, alpha-hydroxy acid, urea and/or ammonium lactate lotion.

- Subject who has been treated with UVB therapy in the last two weeks.

- Subject who has received systemic antibiotics, steroid, tacrolimus, tretinoin,
isotretinoin and/or PUVA within the last 4 weeks.

- Female subjects who are pregnant (positive urine pregnancy test), breast-feeding or
are considering become pregnant during the study period.

- Subject who is currently participating in another clinical trial or has completed a
clinical trial within the last 4 weeks.