Clinical trial NCT05041465: The Cosmetic Effect of Mineral Clay Masks
Official title: The Cosmetic Effect of Mineral Clay Masks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhytides
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Count of Participants with Decrease in Skin pigmentation intensity at 4 Weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: % of Participants with Skin redness intensity improvement at 4 weeks
timeFrame: 4 weeks
Other outcomes:
measure: Patient tolerability survey
timeFrame: 4 weeks
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
References: