Health Condition 1: L810- Postinflammatory hyperpigmentation Health Condition 2: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Sphaerochiol Topical Gel: Dose: 50 g/unit
Participants instructed to apply a thin layer of the gel evenly over all affected psoriatic lesions twice daily (morning and evening)
Duration: 84 days
Control Intervention1: Placebo Gel: Dose: 50 g
Participants instructed to apply a thin layer of the gel evenly over all affected psoriatic lesions twice daily (morning and evening)
Duration: 84 days
Sponsors
KV Natural Ingredients Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be included in the study: 1. Adult male or female subjects aged 18 to 65 years at the time of screening 2. Subjects willing and able to provide written informed consent prior to initiation of any study related procedure 3. Presence of visible hyperpigmentation as determined by the investigator 4. Subjects with clinically diagnosed mild to moderate plaque psoriasis defined as PASI score less than or equal to 20 Body surface Area involvement less than or equal to 20 percent Physician global assessment score less than or equal to 3 5. Subjects with dermatological condition for at least 12 weeks prior to screening 6. Subjects willing and able to comply with study procedures, visit schedule, and investigational product application
Exclusion criteria
Exclusion criteria: Subject meeting any of the following criteria will be excluded from the study 1. Presence of severe psoriasis or non plaque psoriasis variants, including pustular psoriasis or erythrodermic psoriasis. Severe psoriasis will be defined as PASI more than 20 or BSA involvement more than 20 percent or PGA score more than or equal to 4 2. Use of systemic anti psoriatic therapies including corticosteroids, immunosuppressants or biologic agents within 12 weeks prior screening 3. Use of topical psoriasis treatments including corticosteroids, vitamin D analogues or other medicated topical agents within 2 weeks prior screening 4. Presence of any concomitant dermatological condition for examples eczema or atopic dermatitis , vitiligo or active skin infection that in the opinion of the investigator may interfere with study assessments or confound evaluation of study endpoints 5. Known hypersensitivity, allergy or intolerance to the investigational product or any of its components 6. Pregnant or lactating women or women childbearing potential not willing to use adequate contraception during the study period 7. Participation in another clinical trial involving an investigational product or medicinal device within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Sphaerochiol topical gel in reducing post inflammatory hyperpigmentation in subjects with mild to moderate plaque psoriasis associated with PIHTimepoint: Day 0 Day 28 Day 56 Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the chnage in Psoriasis Area and Severity Index ScoreTimepoint: Day 0 Day 28 Day 56 Day 84;To evaluate chnage in pruritus severity using Visual Analog ScaleTimepoint: Day 0 Day 28 Day 56 Day 84;To assess the change in Physician Global Assessment ScoreTimepoint: Day 0 Day 28 Day 56 Day 84;To assess the safety through monitoring of adverse events and local skin tolerabilityTimepoint: Day 0 Day 28 Day 56 Day 84;To assess the mean change in Dermatology Quality of Life score using investigator developed questionnaireTimepoint: Day 0 Day 28 Day 56 Day 84 | — |
Countries
India
Contacts
Public ContactMr Rajesh H
KV Natural Ingredients Pvt Ltd
Outcome results
None listed