Health Condition 1: null- Hand Dermatitis
Conditions
Interventions
Intervention1: Herbavate: To be applied on affected area 3 times a day for 4 weeks
Control Intervention1: Betamethasone plus Gentamycin: To be applied on affected area 3 times a day for 4 weeks
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.18 years of age or older; 2.Have mild to moderate hand dermatitis, according to the Investigator Global Assessment (score2-3); 3.Be generally healthy, as determined by brief medical history; 4.Be capable of understanding and signing the consent form.
Exclusion criteria
Exclusion criteria: 1.Have clinically relevant allergic or irritant contact dermatitis and the inability to avoid exposure; 2.Have severe dermatitis according to the Investigator Global Assessment (score 4); 3.Have severe vesiculation or bullae; 4.Have a history of psoriasis, contact urticaria, and/or pustular diseases; 5.Have had therapy with potent topical corticosteroids within one month prior to enrollment; 6.Have used systemic treatment with oral retinoids, corticosteroids, or with PUVA within the 8 week period prior to the beginning of the study; 7.Have a history or current evidence of a chronic or infectious skin disease 8.Are pregnant or lactating, or women not using highly effective contraception; 9.Current participation in any other interventional clinical trial; 10.Patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use) within 4 weeks prior to randomisation; and 11.Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigators global assessment (IGA) Timepoint: At baseline and at the end of 2 and 4 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment by patients.( PaGA)Timepoint: End of Study (After 4 weeks);No. of adverse event, No. of patients with adverse eventsTimepoint: At end of 2 weeks and 4 weeks of treatment.;Side effects reported during the studyTimepoint: At end of 2 weeks and 4 weeks of treatment.;Total lesion symptom score (TLSS)Timepoint: At baseline and at the end of 2 and 4 weeks of treatment. | — |
Countries
India
Contacts
Public ContactDr Vijaya Jaiswal
Troikaa Pharmaceuticals Limited
Outcome results
None listed