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

NCT00944216 | Terminated Phase 4 Results DMC

• 1 other identifier: KP
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratosis Pilaris

Keywords

keratosis pilaris

Outcome Measures

Primary Outcomes (1)

• Differences Between Week 0 and Week 12 Aggregate Site Severity Score and Investigator Assessment for Site Disease Severity for All Studied Patients.

  12 weeks

Secondary Outcomes (1)

• Change of Subject Assessment of Overall Disease Severity Between Week 0 and Week 12.

  12 wks

Study Arms (1)

Salkera Emollient Foam Treatment

EXPERIMENTAL

All participants will receive this intervention.

Drug: Salkera Emollient Foam

Interventions

Salkera Emollient Foam DRUG

application of the Salkera emollient foam twice a day during the 12 week study period.

Salkera Emollient Foam Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wright State University: lead
• PreCision Dermatology, Inc.: collaborator

Study Sites (1)

Wright State University School of Medicine, Department of Dermatology

Dayton, Ohio, 45408, United States

Location

MeSH Terms

Conditions

Burnett Schwartz Berberian syndrome

Results Point of Contact

• Title: Amy Chen, MD
• Organization: Wright State University School of Medicine, Dept of Dermatology

amy.chen@wright.edu

927-224-3345

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 23, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 4, 2022
• Results First Posted: February 4, 2022

Record last verified: 2022-02

Locations

US (1)