Skip to content

A clinical trial study to evaluate the dermatological safety by primary irritation patch test

A single blind balanced randomized clinical trial to evaluate the dermatological safety of investigational products by primary irritation patch test potential on healthy adult human subjects with sensitive skin (single 24-hour application)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037327
Enrollment
24
Registered
2021-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Rosa E Hydra anti-age firming cream Rosa E Hydra bright lightening cream Rosa E Hydra glow radiance cream Rosa T oil control anit-blemish prebiotic hydra gel Gentle oil to milk make up

Sponsors

Maxwell Pharma SDN BHD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application Subjects who have sensitive skin determined by the Dermatologist on basis of skin sensitivity questionnaires during screening visit. Subjects with positive reaction to lactic acid stinging test Subjects who do not have any previous history of adverse skin conditions and are not under any medication. Subject with good general health as determined by the Investigator on the basis of medical history. Subjects willing to maintain the test patches in designated position for 24 hours. Subjects willing to give a voluntary written informed consent.

Exclusion criteria

Exclusion criteria: Female subject is pregnant, planning for pergnancy or lactating. Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation, pimple marks, open wounds, sunburn, scars, tattoos, cuts, irritation symptoms. Medication which may affect skin response and/or past medical history. Subjects having history of diabetes. Subject suffering from any active clinically significant skin diseases which may contraindicate. Subjects having history of any skin diseases including eczema, atopic dermatitis or active cancer. Subjects having history of asthma or COPD (Chronic obstructivepulmonary disease). Subject with known allergy or sensitization to medical adhesives, bandages.

Design outcomes

Primary

MeasureTime frame
Changes in Skin Condition will be evaluated for scoring after 30 �± 5 minutes of patch removal, 24�±2 hours of patch removal and 168�±2 hours after the patch removal. Changes in Skin Irritation will be evaluated for scoring by asking well-being of subject after 30 �± 5minutes of patch removal, 24�±2 hours of patch removaland 168�±2 hours after the patch removal.Timepoint: 30 �± 5 minutes of patch removal 24�±2 hours of patch removal and 168�±2 hours after the patch removal.

Secondary

MeasureTime frame
To assess the safety of the subject by asking well-being of subject and Adverse event assessmentTimepoint: Day 01, 02, 03, 09.

Countries

India

Contacts

Public ContactDr Senthurselvi R

MBBS MD

senthurselvi.r@spinoslifescience.com9750722032

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026