Skip to content

Study to Assess the Sun Protection Effect of 4 Sunscreen Formulations on Human Skin.

An In Vivo Study to Determine the Sun Protection Factor - SPF of 4 Sunscreen Formulations. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113578
Enrollment
60
Registered
2026-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

None listed

Interventions

Intervention1: Photostable Gold - Sunscreen Gel: Fixed amount of test product will be applied to the skin, then spread over the whole test site using a finger cot. Single application Intervention2: Ph

Sponsors

Sun Pharmaceutical Industries Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 - Healthy adult males and non-pregnant or non-lactating females. 2 - Participants with ITA value of at least 28 using Chromameter and be untanned on the test area. 3 - Participants with uniform skin color over the whole test area and with no variation in ITA greater than 5 from each other or the MEDu test area. 4 - Participants with test sites, free from pigmentation, nevi, sunburn and hair. 5 - Participants with test sites, free from pigmentation, nevi, sunburn and hair. 6 - Participants who are free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the investigator. 7 - Participants who are willing to voluntarily participate in the study and provide signed informed consent. 8 - Participants who are willing and able to comply with all study requirements and procedures throughout the study duration.

Exclusion criteria

Exclusion criteria: 1 - Participants with a history of abnormal responses to the sun e.g., phototoxic or photoallergic responses. 2 - Participants with known allergy or sensitivity to cosmetic products and or any ingredients of the test product. 3 - Participants with systemic dermatological conditions including dysplastic nevi. 4 - Participants having marks, blemishes or nevi in the test area. 5 - Participants having excessive hair in the area on the test on the day of testing. Maybe shaved up to 3 days prior to the test day. 6 - Participants presenting existing sun damage in the test area. 7 - Participants who have used tanning beds in the previous eight weeks prior to SPF testing. 8 - Participants who had sun exposure on their back within the eight weeks leading up to the SPF testing. 9 - Participants using medication with photo-sensitizing potential and or anti-inflammatory medication. 10 - Participants having skeletal protrusions and extreme areas of curvature in the test area. 11 - Participants participating in other similar cosmetic or therapeutic study within last eight weeks. 12 - Any other condition which could warrant exclusion from the study, as per the Dermatologist or investigator discretion.

Design outcomes

Primary

MeasureTime frame
Change in Individual Minimal Erythema DoseTimepoint: Day 05

Secondary

MeasureTime frame
Delayed Erythema ResponseTimepoint: Day 06

Countries

India

Contacts

Public ContactDr Parth Joshi

Sun Pharmaceutical Industries Limited

Bhavesh.Lalan@sunpharma.com7276309223

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026