Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pi… (NCT00944216) | Clinical Trial Compass
TerminatedPhase 4
Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pilaris, a Prospective Study
Stopped: terminated due to administrative reasons.
United States1 participantsStarted 2009-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Differences Between Week 0 and Week 12 Aggregate Site Severity Score and Investigator Assessment for Site Disease Severity for All Studied Patients.