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OpenTrials
Completed

NCT Number: NCT05041465

The Cosmetic Effect of Mineral Clay Masks

The aim of this study is to evaluate the cosmetic effects of commercially available mineral clay masks over a 4-week period. Changes in skin pigmentation, shine, wrinkles, and texture will be assessed.

A second aim of the study is to assess the safety and tolerability of mineral clay masks by assessing redness and participant feedback.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 18-50
  • Individuals in good general health
  • Individuals free of any autoimmune or systemic disorder, which would interfere with the analysis.

Exclusion criteria

  • Individuals who have been on any topical prescribed medications for the past 2 weeks
  • Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator
  • Individuals with active (flaring) disease or chronic skin allergies (atopic dermatitis/eczema) or those who have recently undergone treatment for skin cancer (within the last 12 months) in the area of testing on the forehead, nose and the cheeks
  • Female volunteers who are pregnant or planning to become pregnant over the course of the study. The risk to pregnant women is minimal but the facial appearance can be confounded by the altered hormones associated with pregnancy, as is well documented in chloasma which is dyspigmentation that arises in pregnancy. Women who become pregnant during the duration of the study will become ineligible but there are no birth control requirements.
  • Female volunteers who have started a new hormonal birth control agent or switched to a hormonal birth control agent within the past 60 days
  • Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
  • Individuals who are currently using or during the past 14 days have used a retinoid such as tretinoin, adapalene, or retinol containing agents or a hydroquinone containing agent
  • Individuals who have used mineral clay masks on their face within the last 14 days
  • Individuals with a known history of hypersensitivity to any ingredients to the agent that is being assessed

Treatment and study plan

Clay mask

Other

Clay mask powders- French green, Rhassul and bentonite

Primary outcomes

  1. Count of Participants with Decrease in Skin pigmentation intensity at 4 Weeks

    Time frame: 4 weeks

    Computer and photography based facial image analysis

Secondary outcomes

  1. % of Participants with Skin redness intensity improvement at 4 weeks

    Time frame: 4 weeks

    Computer and photography based facial image analysis

Other outcomes

  1. Patient tolerability survey

    Time frame: 4 weeks

    Survey to grade for side effects

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 13, 2021
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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