Apremilast Topical Gel 2% w/w Phase III clinical trial
- Conditions
- Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhereHealth Condition 2: L988- Other specified disorders of the skin and subcutaneous tissue
- Registration Number
- CTRI/2021/11/038146
- Lead Sponsor
- Aizant Drug Research Solutions Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 351
1. Males or females, = 18 years of age at the time of signing the informed consent document.
2. Understand and voluntarily sign an informed consent document prior to any study related
assessments/procedures being conducted.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Diagnosis of chronic mild to moderate plaque psoriasis i.e., 6 point sPGA score of = 3 and PASI
score of = 10 for at least 10 months with multiple treatable areas (i.e. the lesion should not only
on the face, scalp, genitals or skin folds) which covers less than 10% of the total Body Surface
Area (BSA), and affected area on the limb and/or trunk = 1% BSA. Must be in general good
health (except for psoriasis) as judged by the investigator, based on medical history, physical
examination, and clinical laboratories.
5. Male subjects (including those who have had a vasectomy) who engage in activity in which
conception is possible must use barrier contraception (male latex condom or non-latex condom
NOT made out of natural [animal] membrane [for example, polyurethane]) while on
investigational product and for at least 28 days after the last dose of investigational product.
1. Patients using topical psoriasis medications within the past 2 weeks, and those taking systemic (oral, intravenous, intramuscular, or intradermal) medications for psoriasis in the past 28 days, those using steroids, immune suppressive medications, and cyclooxygenase-2 anti-inflammatory drugs, and those using any medication conflicting with the product ingredients will also excluded from this study.
2. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she participates in the study.
3. Any condition, including other inflammatory diseases or dermatologic conditions, which
confounds the ability to interpret data from the study, including other types of psoriasis (i.e., erythrodermic, guttate, inverse, or pustular psoriasis), other than plaque psoriasis.
4. Prior history of suicide attempt at any time in the subjects life time prior to signing the informed
consent and randomization, or major psychiatric illness requiring hospitalization within the last 3
years prior to signing the informed consent
5. Women planning to become pregnant within 90 days of the start of the study and pregnant or
lactating women or women not taking medically approved birth control were also excluded.
6. Active substance abuse or a history of substance abuse within 6 months prior to signing the
informed consent
7.Exclude the patients who exhibited weight loss greater than equal to 5% of initial body weight.
8. Patients participating in any other clinical trial will be excluded.
9. Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret
data from the study.
10. Patients who are under treatment with apremilast and may include after wash out period.
11. In the opinion of the investigator, the subjects were not considered appropriate candidates.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of the study is to evaluate the Safety and efficacy of Apremilast topical gel, 2% w/w in adult patients with mild to moderate plaque psoriasis: Phase III clinical trial-[NA]Timepoint: 1. Mean Percentage Change from Baseline in the 6 point static sPGA scale at <br/ ><br>week 8 and 12. <br/ ><br>2. Mean Percentage Change From Baseline in Psoriasis Area Severity Index <br/ ><br>(PASI) at Week 8 and 12. <br/ ><br>3. Mean Percentage Change from Baseline in erythema, scale and elevation <br/ ><br>on a 3-point Visual Analog Scale (VAS) at week 8 and 12.
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of the subjectsTimepoint: 1. Mean Change from Baseline in the Dermatology Life Quality Index <br/ ><br>(DLQI) Total Score at Week 8 and 12. <br/ ><br>2. Safety and tolerability throughout study period. <br/ ><br>3. Demonstration of systemic exposure of Apremilast at anticipated Cmax in <br/ ><br>a sub-group of subjects. <br/ ><br>4. Photographs of identified psoriasis lesions of a sub-set of patients on Day 0 <br/ ><br>and Day 84.