Health Condition 1: L209- Atopic dermatitis, unspecified Health Condition 2: null- Eczema
Conditions
Interventions
Intervention1: An Open Label, non-comparative, Phase II, clinical trial was conducted at two sites.: An Open Label, non-comparative, Phase II, clinical trial was conducted at two sites.
Control Interv
Sponsors
Piramal Enterprises Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult males and females >=18 years and less than 75 years of age. 2. Patients having chronic eczema (suffering from eczema from the past 1 year) with an EASI score in the range of 7-15. (Both inclusive). 3. Patient not having any systemic immunosuppressive therapy(eg steroids) 4. Female, not currently pregnant or breast feeding and are using mechanical contraceptive devices such as Intra-uterine devices (IUD). 5. Stable, adequately treated medical conditions other than eczema (such as stable blood pressure, stable hypertension, hyperlipidemia & uncomplicated osteoarthritis). 6. Subjects who are able and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients having history of Medical conditions such as Diabetes mellitus, Thyroiditis, Rheumatoid arthritis, Multiple sclerosis, Uveitis, Glomerulonephritis, Helminthic, uncontrolled hypertension, severe cardiovascular, pulmonary, (especially COPD where steroid treatment is required), cerebral, hematologic, neurological or psychiatric disease. 2. Patient having abnormal values above or below ±20% of the normal value range as mentioned in the protocol. 3. Females using oral contraceptives. 4. History of any topical or herbal drug hyper sensitivity. 5. History of alcoholism& drug abuse. 6. Significant infection such as influenza, acute gastrointestinal symptoms e.g. nausea, vomiting, diarrhea, heartburn) at the time of screening and/or admission. 7. Subjects who have used any investigational drug and /or participated in any clinical trial. 8. Subjects currently receiving drugs like Lithium, B- blockers, Antimalarial and NSAIDs. 9. Subjects receiving any Ayurvedic, Homeopathic or Herbal drug, medicated oils or Creams; medicated shampoos, hair colouring, perms, hair chemical treatments; continuously for one month, three months prior to screening visit. 10. Target lesions associated with secondary infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in the severity of symptoms of Mild to moderate eczema: Erythema, excoriation ; edema/papulation, oozing/crusts lichenification, local pruritus with local SCORAD Index (Screening /Baseline, Day 7,Day 14, Day 21 and Day 28.Timepoint: Day 7,Day 14, Day 21 and Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in inflammation (Screening/baseline, Day 28) 2. Reduction in lesion by Photographic assessment ( Screening /baseline, Day 28) 3. Visual Analogue scale score for relief from itching (pruritus) ( Screening /Baseline, Day 7, Day14, Day 21 and Day 28 4. Patients& Physicianâ?? Global Assessment of the Treatment (Screening /Baseline , Day 28) Timepoint: Day 7, Day 14, Day 21 and Day 28) | — |
Countries
India
Contacts
Public ContactChetna Chotalia
Piramal Enterprises limited
Outcome results
None listed