An interventional study of Health care product (gel) in Sensitivity, Contact, sponsored by Herbarium Laboratorio Botanico Ltda. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-16.
Sponsored by Herbarium Laboratorio Botanico Ltda · Not applicable, Interventional, and Other
This is a clinical study for health care product safety assessment. The research will be conducted with 40 subjects*, aged 18 to 70 years. The product will be applied on the right and/or left participant back for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 24 hours. Medical evaluation will be available throughout the study to assess possible adverse events.
The objective of the study is to observe the effects of the application of the product on the skin and prove the absence of photoallergy and phototoxicity.
* 29 completed the trial
40 subjects, aged 18 to 70 years, phototypes II to III (according to Fitzpatrick classification). The patch test will be used to verify the absence of photoallergy and phototoxicity by the investigational products. The products will be applied twice a week for 3 consecutive weeks, as they are over semi-occlusive dressings. The product will remain in contact with the skin for 24 hours, after product removal the area will be irradiated with ultraviolet lamp A and B (UVA/UVB). Then, the procedure will be repeated after 10 days of wash out.
22 studies on the registry are indexed under Dermatitis, Phototoxic; 1 is open to participants now.
This study's enrollment of 29 is below the median of 35 across 19 interventional studies indexed under Dermatitis, Phototoxic.
Browse Dermatitis, Phototoxic studies →Herbarium Laboratorio Botanico Ltda is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
subjects, 18-70 y, healthy
Other: Health care product (gel)
hyaluronic acid intimate moisturizing gel (to be applied on the subject's skin)
Absence
Absence occurence of phototoxicity and photoallergy
Time frame: 6 weeks
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Herbarium Laboratorio Botanico Ltda