Hepatocellular Carcinoma

Sorafenib 400mg (twice daily), Spread urea cream (urea 20%)

Urea Cream 20%

Sorafenib 400mg (twice daily), Spread placebo cream (urea 0%)

Placebos

Korea University Guro Hospital

The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction

The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction in Patients With Korean Hepatocellular Carcinoma Patients: Multicenter, Prospective Randomized Double-Blind Controlled Study

Comparison of cumulative incidence of HFSR between placebo group and urea cream group

Comparison of cumulative incidence of severe HFSR (grade 2 or grade 3) between placebo group and urea cream group

Comparison of incidence of dose reduction or discontinuation of sorafenib due to HFSR on each group

Assessment of QOL related to HFSR using The Hand-Foot Skin Reaction and Quality of Life Questionnaire (HF-QoL) scoring system. HF-QOL instrument comprises a 20-item symptom scale and an 18-item daily activity scale. Each item was scored from 0 (not at all) to 4 (always or extremely). Therefore, the range of score for HF-QoL was from 0 to 152 points. (Ref. Anderson et al. The Oncoligist 2015;20:831-838)

The occurrence rate of other side effect excluding HFSR

Comparison of incidence of HFSR on 2, 4, 8, and 12 weeks between placebo group and urea cream group

Ji Hoon Kim

Associate professor

Hanmi Pharmaceutical Company Limited

Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis at a dose of 15mg IM every week for 12 weeks. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes.

Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.

Alefacept

Sex: Female, Male

Region of Enrollment

The Eczema Area Severity Index (EASI) measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) using 0=none, 1=mild, 2=moderate, 3=severe. Head/neck, upper limbs, trunk, lower limbs are rated from 1 to 6 (0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%). The proportional factor for the head/neck =.01, upper limbs=.02, trunk=.03 and lower limbs=.04. The algorithm for calculating the EASI is the sum of E+I+Ex+L multiplied by the area, multiplied by the proportional factor. The total score is the sum of the four body-region scores, max=72, min=0.

Change in Eczema Area Severity Index (EASI) Score From Baseline (Week 1) to Week 16.

The Physician Global Assessment (PGA) evaluates the overall severity of Atopic Dermatitis (AD) at a given time using a four point scale (0=clear, 0.5=clear to mild, 1=mild, 1.5=mild to moderate, 2=moderate, 2.5=moderate to severe, and 3=severe).

Change in Physician Global Assessment (PGA) Score From Baseline (Week 1) to Week 16.

Overall Study

Dr. Michael D. Tharp

Atopic Dermatitis

Alefacept 15mg IM every week for 12 weeks

Rush University Medical Center - Department of Dermatology

Study to Evaluate the Safety and Efficacy of Alefacept (Amevive) in Subjects With Moderate to Severe Atopic Dermatitis

A Phase IV, Open Label Study to Evaluate the Safety and Efficacy of Intramuscular (IM) Alefacept (Amevive) 15mg/wk in Subjects 18 Years and Older With Moderate to Severe Atopic Dermatitis

parakeratosis/edema

The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction

Study to Evaluate the Safety and Efficacy of Alefacept (Amevive) in Subjects With Moderate to Severe Atopic Dermatitis

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