CompletedNot Applicable

To Check Dermatological Safety of Test Products by 24 Hours Patch Testing

India26 participantsStarted 2025-07-21

Plain-language summary

Age range18 Years – 65 Years

SexALL

See this in plain English?

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

✓. Age: 18-65 years (both inclusive) at the time of consent.
✓. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
✓. Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
✓. Females of childbearing potential must have a self-reported negative pregnancy test.
✓. Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
✓. Subject is in good general health as determined by the Investigator on the basis of medical history.
✓. Subjects is willing to maintain the test patches in designated positions for 24 Hours.
✓. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.

✕. 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.
✕. Medication which may affect skin response and/or past medical history.
✕. Subject having history of diabetes
✕. 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.
✕. Subject suffering from any active clinically significant skin diseases which may contraindicate.
✕. Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
✕. Participation in any patch test for irritation or sensitization within the last four weeks.
✕. Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).

To evaluate the dermatological safety of the test products

Timeframe: Post patch removal of 30 minutes, 24 hours & 168 hours

NCT IDNCT07060976

SponsorNovamed Laboratories Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-29

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

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

✓. Age: 18-65 years (both inclusive) at the time of consent.
✓. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
✓. Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
✓. Females of childbearing potential must have a self-reported negative pregnancy test.
✓. Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
✓. Subject is in good general health as determined by the Investigator on the basis of medical history.
✓. Subjects is willing to maintain the test patches in designated positions for 24 Hours.
✓. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.

✕. 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.
✕. Medication which may affect skin response and/or past medical history.
✕. Subject having history of diabetes
✕. 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.
✕. Subject suffering from any active clinically significant skin diseases which may contraindicate.
✕. Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
✕. Participation in any patch test for irritation or sensitization within the last four weeks.
✕. Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).