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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00944216
Study type Interventional
Source Wright State University
Contact
Status Terminated
Phase Phase 4
Start date June 2009
Completion date January 2010

See also
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Completed NCT04797663 - Long-pulsed 1064 nm Nd-YAG Laser Versus TCA 20% in Treatment of Keratosis Pilaris Phase 4
Active, not recruiting NCT06032078 - Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris N/A
Completed NCT03243617 - Cosmetic Study of AO+Mist in Improving the Appearance of Skin Afflicted With Keratosis Pilaris N/A
Recruiting NCT05535517 - Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris