The Cosmetic Effect of Mineral Clay Masks

Rhytides Clinical Trial

Official title:

The Cosmetic Effect of Mineral Clay Masks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041465
• Other study ID #: 1296789
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhytides

Intervention

Other:
• Clay mask
Clay mask powders- French green, Rhassul and bentonite

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient tolerability survey	Survey to grade for side effects	4 weeks
Primary	Count of Participants with Decrease in Skin pigmentation intensity at 4 Weeks	Computer and photography based facial image analysis	4 weeks
Secondary	% of Participants with Skin redness intensity improvement at 4 weeks	Computer and photography based facial image analysis	4 weeks