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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: Keratosis pilaris (KP) is a benign skin condition that often is very frustrating for the patients and treating physicians. The investigators are interested to see if the study product is effective in treating moderate to severe KP.

Detailed Summary:

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 sk
Sponsor: Wright State University

Current Primary Outcome: Differences between week 0 and week 12 aggregate site severity score and investigator assessment for site disease severity for all studied patients.

Original Primary Outcome: Same as current

Current Secondary Outcome: Change of subject assessment of overall disease severity between week 0 and week 12.

Original Secondary Outcome: Same as current

Information By: Wright State University

Dates:
Date Received: July 21, 2009
Date Started: June 2009
Date Completion: January 2010
Last Updated: January 19, 2010
Last Verified: July 2009