Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pilaris, a Prospective Study
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pilaris, a Prospective Study|
- Differences between week 0 and week 12 aggregate site severity score and investigator assessment for site disease severity for all studied patients.
- Change of subject assessment of overall disease severity between week 0 and week 12.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||January 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944216
|United States, Ohio|
|Wright State University School of Medicine, Department of Dermatology|
|Dayton, Ohio, United States, 45408|