- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00944216
Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pilaris, a Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Ohio
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Dayton, Ohio, United States, 45408
- Wright State University School of Medicine, Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Salkera Emollient Foam Treatment
All participants will receive this intervention.
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application of the Salkera emollient foam twice a day during the 12 week study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences Between Week 0 and Week 12 Aggregate Site Severity Score and Investigator Assessment for Site Disease Severity for All Studied Patients.
Time Frame: 12 weeks
|
12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Subject Assessment of Overall Disease Severity Between Week 0 and Week 12.
Time Frame: 12 wks
|
Subject disease severity score: None (0), mild (1), mild/moderate (2), moderate (3), moderate/severe (4), severe (5).
|
12 wks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keratosis Pilaris
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Northwestern UniversityCompleted
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Premier Specialists, AustraliaRecruitingKeratosis PilarisAustralia
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Cairo UniversityCompletedKeratosis PilarisEgypt
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Mayo ClinicCompletedPITYRIASIS RUBRA PILARISUnited States
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PeplinCompletedSeborrheic KeratosisAustralia
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Aclaris Therapeutics, Inc.CompletedSeborrheic Keratosis (SK)United States
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DermBiont, Inc.Active, not recruitingA Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic KeratosisSeborrheic KeratosisUnited States
Clinical Trials on Salkera Emollient Foam
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Callender Center for Clinical ResearchUnknown
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John FowlerAvadim Technologies, Inc.Withdrawn
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Therapeutics, Inc.CompletedPlaque PsoriasisUnited States
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Therapeutics, Inc.CompletedPlaque PsoriasisUnited States
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Therapeutics, Inc.CompletedPlaque PsoriasisUnited States
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Daniel Muñoz-GarciaCamilo Jose Cela UniversityCompleted
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Arcutis Biotherapeutics, Inc.CompletedSeborrheic DermatitisUnited States, Canada
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Celal Bayar UniversityIzmir Katip Celebi UniversityCompleted
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Arcutis Biotherapeutics, Inc.CompletedSeborrheic DermatitisUnited States, Canada
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Skin Sciences, PLLCUnknownPlaque PsoriasisUnited States