Last updated: August 9, 2022
Sponsor: Lipidor AB
Overall Status: Active - Recruiting
Phase
3
Condition
Rash
Warts
Skin Wounds
Treatment
N/AClinical Study ID
NCT05249972
CRSC20008
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or non-pregnant female subjects aged >18 years having either Fitzpatrick skintype I-III or IV-VI at the time of screening.
- A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris on body, or bodyand scalp, involving 5 to 10% of body surface area (BSA) and PASI ≤10., that does notinclude the face, axilla and groin areas.
- Mild or moderate Psoriasis on Physician Global Assessment (PGA) score (grade 2 - 3).
- A plaque elevation of at least moderate severity (grade ≥ 3) at the target lesionsite. The most severe lesion at Baseline should be identified as the target lesion.
- Subjects must be willing to provide written informed consent.
- Subjects must be willing and able to understand and can comply with studyrequirements, apply the medication as instructed and be able to complete the study.
- Subject must be in general good health as judged by the Investigator, based on medicalhistory and physical examination.
Exclusion
Exclusion Criteria:
- Subject with history of hypersensitivity to betamethasone or calcipotriol or anycomponent of the test or reference product or placebo.
- Current diagnosis of unstable forms of psoriasis in the treatment area includingguttate, erythrodermic, exfoliative, or pustular psoriasis.
- Subjects with diagnosis of mild to moderate psoriasis only in the scalp area.
- Other inflammatory skin disease in the treatment area that may confound the evaluationof the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporisand seborrheic dermatitis).
- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in thetreatment areas, which could interfere with the rating of efficacy parameters.
- Subject with history of psoriasis unresponsive to topical treatments.
- Subject with psoriasis lesions predominantly on palms and soles or palmo-plantar area.
- Subjects with the diagnosis pustulosis palmo-plantaris
- Subject in need of systemic treatment
- Ongoing use of other psoriasis treatment including but not limited to topical orsystemic corticosteroids, other topical medications (i.e. coal tar), oral or biologicmedications for the treatment of psoriasis, and UV therapy.
- Use of oral estrogen therapy, excluding oral contraceptive pills
- Females who are pregnant, nursing, or planning a pregnancy
- Females of childbearing potential who do not agree to utilize an adequate form ofcontraception.
- Current significant medical problems that, in the discretion of the investigator,would put the subject at significant risk
- Use of any investigational drug within 4 weeks prior to randomization, or 5pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
- Current or past history of hypercalcemia, calcium metabolism disorder, vitamin Dtoxicity, severe renal insufficiency, or severe hepatic disorders.
- Current immunosuppression
- Use of biologic treatment for psoriasis (e.g., infliximab, adalimumab, alefacept)within six months prior to Baseline.
- Use of: 1) chemotherapy, or 2) radiation therapy, within three months prior toBaseline.
- Use of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) oralretinoids, within two months prior to Baseline.
- Use of: 1) systemic steroids, 2) systemic antibiotics, 3) other systemic antipsoriatictreatment, 4) PUVA therapy, 5) UVB therapy, or 6) systemic anti-inflammatory agents,within one month prior to Baseline.
- Use of: 1) topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar,calcipotriol, tazarotene), 2) topical corticosteroids, or 3) topical retinoids, within 2 weeks prior to Baseline.
- Use of medicated shampoos with possible effect on psoriasis
- Subject with positive serology tests like HIV, HCV & HBsAg.
Study Design
Total Participants: 294
Study Start date:
January 24, 2022
Estimated Completion Date:
August 18, 2022
Study Description
Connect with a study center
Lotus Multispeciality Hospital
Ahmedabad,
IndiaActive - Recruiting
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