Will pinorox cream irritate skin? a patch test seeks answers
NCT ID NCT07065149
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This trial checks whether Pinorox cream, in two strengths, irritates the skin of healthy adults. About 26 people aged 18 to 65 will have small patches with the cream, a mild irritant, and a control placed on their backs for 24 hours. Researchers will then grade any skin reaction from none to severe. The goal is to see if the cream is safe for skin contact.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pinorox cream (0.1% and 1%) applied to the skin via patch test
- What this could lead to
- If the cream causes no skin irritation, it could support its safe use in future skin products.
- What could go wrong
- This is a small early safety test, not a proof of effectiveness. Results may not reflect real-world use, and some people may still react.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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26 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1\) Age: 18-65 years (both inclusive) at the time of consent. 2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females). 3) Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale). 4) Females of childbearing potential must have a self-reported negative pregnancy test. 5) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results. 6) Subject is in good general health as determined by the Investigator on the basis of medical history. 7) Subjects is willing to maintain the test patches in designated positions for 24 Hours. 8) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 9) Subject must be able to understand and provide written informed consent to participate in the study. 10) Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given. 11) For Sensitive Skin Condition Only: * Subject scoring greater than 30 for Section 2 - Sensitive v/s Resistant skin in modified Dr Baumann's\* skin type questionnaire. * Subject with sensitive skin as confirmed by Lactic Acid Stinging Test. Exclusion Criteria: 1. Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading. 2. Medication which may affect skin response and/or past medical history. 3) Subject having history of diabetes 4) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months. 5\) Subject suffering from any active clinically significant skin diseases which may contraindicate. 6) Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer. 7) Participation in any patch test for irritation or sensitization within the last four weeks. 8) Subject having history of asthma or COPD (Chronic obstructive pulmonary disease). 9) Use of any: i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application. 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. 12) Individual who has a medical condition or is taking or has taken a medication which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk. 13) Subject with known allergy or sensitization to medical adhesives, bandages. 14) Participation in other patch study simultaneously.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NovoBliss Research
Ahmedabad, Gujarat, 382481, India