Investigators have designed a pilot study involving chronic hand dermatitis (CHD) patients who attend the dermatology clinic at the George Washington Medical Faculty Associates (GW MFA) in order to assess the efficacy and safety of apremilast treatment for the treatment of moderate to severe CHD.
Hand dermatitis is one of the most common skin disorders encountered by dermatologists. Chronic hand dermatitis (CHD) is often due to allergic contact dermatitis (ACD) or irritant contact dermatitis (ICD) and has a 1-year and lifetime prevalence of up to 10% and 15%, respectively, in the general population. On average, the disease affects patients for about 7 to 11 years. Patients with ACD show an increase in cytokines produced from T helper (Th)1 and Th17 cells, including (interleukin) IL-17 and IL-23, which are also implicated in the pathogenesis of psoriasis. Apremilast, a small molecule phosphodiesterase-4 (PDE-4) inhibitor, has demonstrated clinical efficacy and tolerability in the treatment of psoriasis and psoriatic arthritis, likely through the blockade of IL-17, IL-23, and several other pro-inflammatory mediators. Therefore, it may provide an effective treatment option for other Th1 and Th17-mediated disease (such as CHD due to ACD and ICD), which share a common immunologic pathway with psoriasis. Investigators hypothesize that apremilast has the ability to decrease disease severity in patients with moderate-to-severe CHD that is either secondary to psoriasis, or occurring in patients with an atopic or allergic past medical history. Hence, investigators have designed a pilot study involving CHD patients who attend the dermatology clinic at the George Washington Medical Faculty Associates (GW MFA) in order to assess the efficacy and safety of apremilast treatment for the treatment of moderate to severe CHD. The objectives are as follows: Primary objective: 1\. To evaluate the efficacy of Apremilast 30mg twice daily administered as monotherapy in the treatment of moderate-to-severe CHD as assessed by improvement of the Physician Global Assessment (PGA). Secondary objectives: 1. To evaluate the safety and tolerability of Apremilast 30mg twice daily as assessed by monitoring adverse events, laboratory values (CBC, CMP), and physical examination. 2. To evaluate CHD lesion time to response (TTR) as assessed by Modified Total Lesion Symptom Score (mTLSS). 3. To evaluate the patient's perception of CHD severity improvement as assessed by the Patient Global Assessment (PaGA). 4. To evaluate the patient's health-related quality of life as assessed by the Dermatology Life Quality Index (DLQI) questionnaire a measurement of the patient's subjective symptoms. STUDY ENDPOINTS Primary endpoint: 1\. Proportion of patients achieving a 2 point decrease in Physician Global Assessment (PGA) at the end of the study. Secondary endpoints: 1. Proportion of patients achieving Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) at end of study. 2. Change in mTLSS, patient global assessment, and DLQI scores from baseline to end of study. 3. Photographic improvement of CHD from baseline to end of study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Apremilast 30 mg tablet
George Washington University Department of Dermatology
Washington D.C., District of Columbia, United States
To evaluate the efficacy of Apremilast 30mg twice daily administered as monotherapy in the treatment of moderate-to-severe CHD as assessed by improvement of the Physician Global Assessment (PGA).
PGA classifies the severity of CHD into five categories (clear, almost clear, mild, moderate, and severe). The PGA scale ranges from 0 (no symptoms) to 4 (severe disease). PGA ratings will be based on an integrated clinical picture of signs, symptoms, and the extent of disease.
Time frame: 24 weeks
To evaluate the safety and tolerability of Apremilast 30mg twice daily through incidence of adverse events.
Evaluation of all adverse events from Day 0 to Week 24.
Time frame: 24 weeks
To evaluate CHD lesion time to response (TTR) as assessed by Modified Total Lesion Symptom Score (mTLSS).
The mTLSS is a 4-point scale that is calculated as sum of assigned scores for the symptoms of erythema, scaling, lichenification/hyperkeratosis, vesiculation, edema, fissures and pruritus/pain. The total score ranges from 0 (best) to 21 (worst). Scores will be assigned for the most affected side (palmar or dorsal) of the most affected hand. The investigator will assign mTLSS scores for patients at all visits.
Time frame: 24 weeks
To evaluate the patient's perception of CHD severity improvement as assessed by the Patient Global Assessment (PaGA).
Patients will be asked by the investigator to grade their overall change from baseline by selecting one of the following descriptions, which best matches their perception of overall treatment effect: cleared or almost clear (at least 90% clearing), marked improvement (at least 75% clearing), moderate improvement (at least 50% clearing), mild improvement (at least 25% clearing), no change, or worsening.
Time frame: 24 weeks
To evaluate the patient's health-related quality of life as assessed by the Dermatology Life Quality Index (DLQI) questionnaire a measurement of the patient's subjective symptoms.
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The DLQI is a 10-item, validated questionnaire used to assess the impact of dermatitis disease symptoms and treatment on quality of life (QOL). Patients are asked to assess QOL over the past week with a simple response (0 to 3; where 0 = "not at all" and 3 = "very much"), with an overall scoring system of 0 to 30 and a high score being indicative of a poor QOL.
Time frame: 24 weeks