Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pilaris, a Prospective Study
Condition: Keratosis Pilaris
MeSH terms: Keratosis, Actinic; Abnormalities, Multiple; Darier Disease; Keratosis
Intervention: Salkera Emollient Foam
Intervention description: application of the Salkera emollient foam twice a day during the 12 week study period.
Intervention MeSH terms: Emollients
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: keratosis pilaris

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.
    

Eligibility criteria:

        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.