Apremilast and Moderate to Severe Chronic Hand Dermatitis (CHD)
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|ClinicalTrials.gov Identifier: NCT03741933|
Recruitment Status : Not yet recruiting
First Posted : November 15, 2018
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hand Dermatitis||Drug: Apremilast 30mg||Phase 4|
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:
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).
- To evaluate the safety and tolerability of Apremilast 30mg twice daily as assessed by monitoring adverse events, laboratory values (CBC, CMP), and physical examination.
- To evaluate CHD lesion time to response (TTR) as assessed by Modified Total Lesion Symptom Score (mTLSS).
- To evaluate the patient's perception of CHD severity improvement as assessed by the Patient Global Assessment (PaGA).
- 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.
1. Proportion of patients achieving a 2 point decrease in Physician Global Assessment (PGA) at the end of the study.
- Proportion of patients achieving Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) at end of study.
- Change in mTLSS, patient global assessment, and DLQI scores from baseline to end of study.
- Photographic improvement of CHD from baseline to end of study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will be patients that have been screened within the Department of Dermatology at the GW MFA. Individuals meeting inclusion and exclusion criteria will be enrolled into the study. A total of 10 patients will be enrolled in the study and each patient will be given Apremilast 30 mg twice daily to be administered for a period of 6 months. Patients will present to clinic for clinical assessments, adverse event monitoring, laboratory testing, and/or photography at the following time periods of therapy: baseline and 2 weeks, 4 weeks, and every 4 weeks thereafter until completion of the 6 month treatment period. Additionally, all patients will be required to return for a 4-week follow up visit after completing the final dose of the study medication.|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-Arm Pilot Study Investigating the Efficacy and Safety of Apremilast for the Treatment of Moderate to Severe Chronic Hand Dermatitis|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
30 mg twice daily to be administered for a period of 6 months
Drug: Apremilast 30mg
Apremilast 30 mg tablet
- 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). [ Time Frame: 24 weeks ]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.
- To evaluate the safety and tolerability of Apremilast 30mg twice daily through incidence of adverse events. [ Time Frame: 24 weeks ]Evaluation of all adverse events from Day 0 to Week 24.
- To evaluate CHD lesion time to response (TTR) as assessed by Modified Total Lesion Symptom Score (mTLSS). [ Time Frame: 24 weeks ]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.
- To evaluate the patient's perception of CHD severity improvement as assessed by the Patient Global Assessment (PaGA). [ Time Frame: 24 weeks ]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.
- 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. [ Time Frame: 24 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741933
|Contact: Alison Ehrlich, MDfirstname.lastname@example.org|
|Contact: Kamaria N Nelson, MDemail@example.com|
|United States, District of Columbia|
|George Washington University Department of Dermatology||Not yet recruiting|
|Washington, District of Columbia, United States, 20037|
|Contact: Alison Ehrlich, MD, MHS 202-741-2619 firstname.lastname@example.org|
|Principal Investigator: Alison Ehrlich, MD, MHS|