Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Marketed Test Product: Topical Application
Frequency: Single Application
Spread the cream in the same direction and avoid scratching after application.
Control Intervention1: Control Pr
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 65 years (both inclusive) at the time of consent having mild to moderate atopic dermatitis. 2) Sex: Healthy male and non-pregnant/non-lactating females. 3) Females of childbearing potential must have a self-reported negative pregnancy test. 4) Subject are generally in good health. 5) Subjects who agree to come to the facility with clean and dry scalp and hair 6) Subjects 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 7) Subjects are not allowed to participate in any other study until this study is complete. 8) Subjects willing and able to follow the study directions. 9) Having childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/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. 10) Subjects willing to give written consent through subject information sheet. 11) Subjects have not participated in a similar investigation in the past three months. 12) Subjects willing to use test product throughout the study period.
Exclusion criteria
Exclusion criteria: 1) History of any dermatological condition of the skin diseases. 2) Subject with present condition of allergic response to any cosmetic product. 3) Subjects with other dermatologic diseases besides AD whose presence or treatments could interfere with the assessment of disease (eg, Psoriasis). 4) Subjects who used systemic immunosuppressants within 4 weeks, topical steroids or immunomodulators within 1 week, moisturizers within 12 hours before evaluation. 5) History of alcohol or drug addiction. 6) The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances. 7) 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. 8) Subjects having diabetes, hepatitis, epilepsy, thyroid or have or had any kind of cancer. 9) The subject must not have participated in a clinical study within 4 weeks prior to the screening visit of this study. 10) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion. 11) Pregnant or breastfeeding or planning to become pregnant during the study period. 12) History of chronic illness which may influence the cutaneous state.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate neurosensory responses associated with pain, pruritus, and discomfort in subjects with atopic dermatitis, by comparing EEG activity at baseline and after application of the test products, as well as between the active product and placebo groups. The objective will specifically assess changes in alpha, beta, and theta brainwave activity. Timepoint: The primary endpoint will be the change in neurosensory responses related to pain and discomfort in subjects with atopic dermatitis, measured through EEG recordings (Muse® EEG headband) at three time points: Baseline (before application) Post-stimulus induction 30 minutes after product application | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: NA | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Pvt Ltd
Outcome results
None listed