None listed
Conditions
Interventions
Intervention1: Boddess Naturals Multani Mitti, Haldi & Chandan Face Wash: Neat 0 04ml single dose
topical application for 24 hr
Intervention2: Boddess Brightening Toner: Neat 0 04ml single dose topica
Sponsors
HOUSE OF BEAUTY PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: I. Age Criteria: Individuals aged 18 to 65 years (inclusive) II. Gender: Both male and female participants may be included; however, A balanced representation of both genders is preferred. III. Skin Type: Participants should have normal Fitzpatrick skin type III to V skin types. IV. Health & Medication Status: Subjects must have no known history of skin-related disorders and should not be on medications that could affect study results. V. General Health Condition: Only those in good general health, as assessed by the Investigator through medical history, will be enrolled. VI. Patch Retention: Participants must be willing to keep the test patches applied at the specified site for 24 hours without disturbance. VII. Protocol Compliance: Subjects must be capable of understanding study procedures and committed to attending all scheduled visits and following study instructions. VIII. Consent: Written informed consent must be obtained from each participant prior to inclusion in the study. IX. Identity: having valid proof of identity and age
Exclusion criteria
Exclusion criteria: I. Individuals presenting with skin abnormalities at the test site (back or upper arm), such as irritation, lesions, excessive terminal hair, moles, pigmentation, acne, tattoos (within the past 3 months), scars, sunburn, open wounds, cuts, abrasions, or any dermatological condition that may interfere with evaluation will be excluded. II. Participants using medications or having a medical history that could influence skin response or study outcomes will not be considered. III. Individuals with a known history of diabetes will be excluded. IV. Subjects with a history of mastectomy involving lymph node removal within the past year, or those who have undergone treatment for any form of cancer within the previous 6 months, will not be eligible. V. Participants with any active, clinically significant skin disease that may contraindicate study participation will be excluded. VI. Individuals with a history of chronic or recurrent skin conditions, such as eczema or atopic dermatitis, or with any active malignancy, will not be included. VII. Participation in any irritation or sensitization patch study within the last 4 weeks will lead to exclusion. VIII. Subjects with a history of respiratory conditions such as asthma or Chronic Obstructive Pulmonary Disease will be excluded. IX. Use of the following medications prior to patch application will result in exclusion: X. Prescription or over-the-counter anti-inflammatory drugs within 5 days prior to application. XI. Antihistamines or immunosuppressive agents within 7 days prior to the first patch application. XII. Systemic or topical corticosteroids at the application site within 4 weeks prior to product use (excluding steroidal nasal or ophthalmic preparations). XIII. Use of any topical medication at the intended application site will not be permitted. XIV. Individuals with self-reported immunological disorders, such as HIV, AIDS, or Systemic Lupus Erythematosus, will be excluded. XV. Any participant with a medical condition or ongoing/past medication use that, in the Investigator s opinion, could compromise safety or affect study results will not be enrolled. XVI. Individuals with known hypersensitivity or allergic reactions to medical adhesives or bandages will be excluded. XVII. Simultaneous participation in another patch test study or therapeutic study is not permitted. XVIII. Female Participant is Pregnant or Lactating XIX. Study participants working with Medivigilant Research Pvt. Ltd.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment of test products for Irritation potential using Draize scale after patch removal 24 hr as per IS 4011:2018Timepoint: baseline, 24 hr, 48 hr & 1 week | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactMrAJEET KUMAR
Medivigilant Research Pvt Ltd
Outcome results
None listed