A Study to Evaluate the Safety and Non-Comedogenic Effect of a Skin Care Product in Healthy Volunteers.

A Prospective, open-label, one arm study to evaluate the safety and efficacy of Skin care product for its non-comedogenic effect in healthy male or female volunteers. - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090443

Enrollment

Registered

2025-07-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

None listed

Interventions

Intervention1: SHRUMEI Dark Spot Corrector serum: Take small amount of cream and gently massage it on the skin in the morning and in the evening after washing the face and patting it dry, Duration 30

Eligibility

Inclusion criteria

Inclusion criteria: Healthy Indian male and female healthy volunteers aged between 18-55 years. Willing to give Informed Consent Form. Subjects with Clear to mild skin condition according to GAGS score 0 to 18. Willing to complete the study assessments questionnaires. Willing to avoid usage of his or her own moisturizers and face Cream for at least one week before Commencement and during this study.

Exclusion criteria

Exclusion criteria: Pregnancy or breast feeding. Patients with pre existing severe systemic disease necessitating long-term medication. Patients with mild to severe Anaphylaxis reactions. Evidence of significant uncontrolled co-morbid disease. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments. Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.

Design outcomes

Primary

Measure	Time frame
Primary Outcomes: 1.Percentage evaluation in Global Acne Grading System (GAGS Score) 2.Evaluation of blocked pores through pore indicator test. 3.Visual observation of Comedones through Videoscopy. 4.Evaluation of cutaneous melanin by Mexameter.Timepoint: Day 0, Day 15, Day 30.	—

Secondary

Measure	Time frame
To evaluate the consumer acceptance as well as their response towards the product through a feedback questionnaire.Timepoint: Day 0, Day 15, Day 30.	—

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt Ltd.

surya.ashok@gmail.com09880999297

Outcome results