NovoBliss Research Pvt.Ltd
Ahmedabad, Gujarat, 382481, India
NCT Number: NCT06631898
This is single-center, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion or semi occlusion or open patch for at least 24 hours (± 2 hours). safety will be assed through the study by monitoring of adverse event A sufficient number 26 subject will be enrolled to get 24 completed the study. There are total three visits in this study and are optional visit pre-screening visit : Lactic Acid Stinging test& Modified Dr baumenn's skin type questionnaire. Visit 01: Screening, Enrollment, and Patch Application (Day 01) Visit 02: Patch Removal After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal Visit 03: 24 (± 2 hour) irritation scoring (Day 03) visit 04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site. Follow-up visit for reactions if any to confirm recovery (optional deemed necessary) Irritation scoring at 168 ± 2 hours post-patch removal (Day 09)
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Ahmedabad, Gujarat, 382481, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
iii. Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted) 10) Topical drugs used at application site. 11) Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
A 0.04 gm of test products along with controls (negative and positive) will be applied on the back of subjects i.e. between the scapula and waist through Finn chamber patch.
Time frame: Irritation Scoring at T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if needed.
Dermatological safety of the test products by 24 Hours Patch Test will be evaluated by 0: No reaction and 4 Severe Reaction
Time frame: At T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if required.
To evaluate the Safety of the skin by visual dermatological assessment by 0: No reaction and 4 Severe Reaction
NovoBliss Research Pvt Ltd
Other
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test Under Complete Occlusion or Semi Occlusion or Open Patch on Adult Healthy Human Subjects.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02889159
Normal Skin, Photoaged Skin
Ann Arbor, Michigan, United States
View Trial DetailsNCT04221126
Normal Skin
Copenhagen, Copenhagen NV, Denmark
View Trial DetailsNCT07065149
Normal Skin
View Trial Details