Safety Assessment of Over-the-counter Personal Care and Cosmetic Products Ingredients Based on Product Description

Safety Assessment of Over-the-counter Personal Care and Cosmetic Products Ingredients Based on Product Description and Properties

"Personal care and cosmetic products maintain hygiene, enhance aesthetics and promote wellbeing. This category includes various formulations for cleansing, grooming and beautification products for skin, hair, nails, lips and teeth.

Study Overview

• Status: Completed
• Conditions: Cosmetic Product Causing Toxic Effect
• Intervention / Treatment: Combination product: Cosmetic Products

Detailed Description

This study evaluates the safety of ingredients in 100 over the counter personal care and cosmetic products. Stratified sampling selects products from various categories, brands and retailers.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Pharmacies (Mehmood Pharmacy, Servaid Pharmacy, Clinix+ Pharmacy), Supermarkets (Hyperstar, Metro cash and carry, Imtiaz supermarket), Departmental stores (AL Fatah, Haji cream bakhsh, Enem store), Online retailers (Saloni.pk, Just4Girls.pk, Daraz.pk)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Safety Assessment of Over-the-counter Personal Care and Cosmetic Products' Ingredients Based on Product Description.

Description

Inclusion Criteria:

• Over the counter personal care products available for consumer purchase,Products from various categories (e.g., skincare, haircare, makeup, eye care),
• Products from different brands and manufacturers,Products with ingredient labels or lists available,Products marketed for general consumer use (not specialized or prescription products).

Exclusion Criteria:

• Prescription-only products or those requiring medical supervision,Products intended for specialized use (e.g., medical conditions, sensitive skin)
• Products without ingredient labels or lists.
• Products from obscure or unreliable manufacturers
• Products with expired or near-expired ingredients.
• Products with unclear or misleading labelling,Products not intended for general consumer use (e.g., professional salon products),Products with ingredients already known to be harmful or banned by regulatory agencies.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert scales	Likert scales commonly comprise either five or seven options. The options on each end are called response anchors. The midpoint is often a neutral item, with positive options on one side and negative options on the other. Each item is given a score from 1 to 5 or 1 to 7	12 months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): June 22, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MSAHS/Batch-Spring23/024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No