Health Condition 1: L300- Nummular dermatitis
Conditions
Interventions
Intervention1: HVGC-091525 ointment: Topical application twice daily for the period of 30 days.Duration: 30 days, Route- topical. Dose- Apply a small amount of medicine to the affected area and gently
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: Both male and female subject presenting with signs and symptoms of various dermatitis such as allergic, irritant, nummular, dyshidrosis(pompholyx) and pityriasis alba Subject presenting with signs and symptoms of dermatitis such as like, pain, itching, burning, dryness, redness, induration, peeling, scaling, fissure, vesicles and bullae Both male and female subject aged between 18-65 years, both inclusive at the time of consent Investigators Static Global Assessment ISGA score of 2 mild or 3 moderate Subject has contact dermatitis covering between 0.5% to 10% of the total Body Surface Area (BSA at Screening/Day 1. Subject must be willing and able to avoid the causative allergens during the study.
Exclusion criteria
Exclusion criteria: Clinically infective and atopic dermatitis Any dermatological condition other than irritant dermatitis History of allergy or sensitivity to investigational product Current diagnosis or history or any disease, which in the Investigators opinion would contraindicate the use of IP Subjects using steroids or any other medications for the same indication in last 2 weeks and not willing to discontinue the treatment Pregnant and lactating women History of ongoing, chronic or recurrent infectious disease / lymphoproliferative disease or history of malignancy of any organ system within the past 5 years History of Alcohol or smoking abuse Patients unwilling to provide informed consent or abide by the requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 percent of participants who will achieve treatment success ISGA score of 0 (clear) or 1 (almost clear) and or with at least a 2-grade improvement from baseline.Timepoint: Day 8, 15 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to success in ISGA. i.e., the time at which 30% of the subjects achieved success in ISGA â?¢ Reduction in NRS (Numerical rating scale of 0-10, where Nil to Severe) for itching, burning, dryness, redness, induration, peeling, scaling, fissure, vesicles, bullae. â?¢ Improvement in the quality of life questionnaire (Dermatology Life Quality Index-DLQI) Timepoint: 30 days | — |
Countries
India
Contacts
Public ContactDrSrikrishna H A
The Himalaya Drug Company
Outcome results
None listed