CompletedNot Applicable

Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Phototoxicity.

Brazil55 participantsStarted 2020-10-26

Plain-language summary

This is a clinical study for health care product safety assessment. The research is going to conducted with 55 subjects, aged 18 to 70 years. The product is applied on the right and/or left participant back. After a wash out, the product is reapplied. Medical evaluation will be available throughout the study to assess possible adverse events. The main of the study is to observe the effects of the application of the product on the skin and prove the absence of irritability and/or allergy, photoallergy and phototoxicity.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy participants; * Non-injured skin in the test region; * Agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations; * Ability to consent to participation in the study; * Phototype (Fitzpatrick): II and III; Exclusion Criteria: * Pregnant or breastfeeding women; * Use of the following systemic drugs: antihistamines, non-hormonal anti-inflammatory drugs and corticoids; * History of allergy to cosmetics, topical products or research product; * Localized or widespread dermatological diseases or inflammatory dermatoses active and nerve damage in the test region; * Personal or family pathological history of skin cancer; * Use of topical or systemic photosensitizing medication; * History of phototoxic, photoallergic reactions, dermatoses caused by light, atopy, pathologies aggravated or triggered by ultraviolet radiation; * Photo-induced pathologies; * Frequent exposure to the sun or tanning chambers; * Participated in an allergenicity study in a period of less than 4 weeks from the start of the study; * Skin marks in the experimental area that interfere with the evaluation of possible reactions; * Active dermatoses; * Forecast to take a bath in the sea, pool or sauna during the study; * Participants who play water sports; * Dermography; * Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Erythema degree or absence

Timeframe: 39 days

Trial details

NCT IDNCT04332445

SponsorHerbarium Laboratorio Botanico Ltda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-03

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