Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Investigational Treatment Cream: Manufactured by: Chemyunion Inc
Mode of Application: 1) The treatment should be applied to clean, dry skin, free of any other cosmetic product that the
IMPORTANT: The number of "pumps" per region should be decided on first use, based on the size of the affected area.
Dosage Form: Cream
Route of Administration: Topical
Duration: 14 Dyas
Frequency: 2
IMPORTANT: The number of "pumps" per region should be decided on first use, based on the size of the affected area.
Dosage Form: Cream
Duration: 14 Days
Route of Administration: Topical
Frequency: 2
Sponsors
Chemyunion Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 20 to 65 years at the time of consent. 2) Sex: Male and non-pregnant or non-lactating females. 3) Females of childbearing potential must have a self-reported negative pregnancy test. 4) Subject are generally in good health. 5) Subject s with mild to moderate Atopic Dermatitis determined by Eczema Area and Severity Index (EASI) score with moderate erythema (redness: score 2) and mild scratch mark (scratching: score 1) will be enrolled into the study 6) Subjects diagnosed with mild to moderate atopic dermatitis of greater than or equal to 6 months duration, with at least one active lesion accessible for instrumental measurements. 7) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for atopic dermatitis in last 1 month. 8) Subjects are not allowed to participate in any other study until this study is complete. 9) Subjects willing and able to follow the study directions. 10) Having childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device or injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. 11) Subjects willing to give written informed consent. 12) Subjects willing to use test treatment throughout the study period. 13) Subjects must agree to record each use of the test treatments in the subject s diary card on daily basis. 14) Subjects must agree to record medication use during the study.
Exclusion criteria
Exclusion criteria: 1) History of any skin condition other than atopic dermatitis. 2) Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last one month. 3) History of alcohol or drug addiction. 4) The subject has a known allergy or sensitivity to treatment ingredients. 5) The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject. 6) History of other significant dermatological or systemic diseases that may interfere with study participation or data interpretation. 7) Known neurological or psychiatric disorders that could interfere with EEG assessments. 8) The subject must not have participated in a clinical study within 4 weeks prior to the pre- screening visit of this study. 9) Pregnant or breastfeeding or planning to become pregnant during the study period. 10) History of chronic illness which may influence the cutaneous state.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the effectiveness of the test treatments by assessing change in pain and discomfort associated with atopic dermatitis within each treatment group and between treatment groups by using EEG through the Neurologist and/or Neurologist trained evaluator. 2.To evaluate the effectiveness of the test treatments by assessing change in Dry Skin/Ichthyosis Area and Severity Index (DASI) within each treatment group and between treatment groups by dermatologist trained evaluator and/or dermatologist. 3.To evaluate the effectiveness of the test treatments by assessing changes in SCORAD severity scoring, Eczema Area and Severity Index within each treatment group and between treatment groups by dermatologist trained evaluator and/or dermatologist.Timepoint: from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test treatments by assessing change in visual and tactile assessment of skin including skin scaliness, skin roughness, skin redness, skin itchiness, skin dryness and skin smoothness within each treatment group and between treatment groups by dermatologist trained evaluator and dermatologist.Timepoint: from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14;To evaluate the effectiveness of the test treatments by assessing change in Visual Analogue Scale for Itching within each treatment group and between treatment groupsTimepoint: from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14;To evaluate the effectiveness of the test treatments by assessing change in skin hydration within each treatment group and between treatment groups by using Corneometer CM 825.Timepoint: from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14;To evaluate the effectiveness of the test treatments by assessing change in skin barrier function within each treatment group and between treatment groups by using Tewameter TM Hex.Timepoint: from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14;To evaluate the effectiveness of the test treatments by assessing change in skin topography including skin roughness, skin smoothness, skin scaliness and skin wrinkles within each treatment group and between treatment groups by using Visioscan VC 20 Plus.Timepoint: from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14;To evaluate the effectiveness of the test treatments by assessing change in skin erythema and melanin within each treatment group and between treatment groups by using Mexameter MX 18.Timepoint: from baseline before usage, after stimulus induction and 30 mins after test tr | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed