The Cosmetic Effect of Mineral Clay Masks | NCT05041465

Studies
The Cosmetic Effect of Mineral Clay Masks

NCT05041465

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Sep 13, 2021Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

Rhytides

Interventions

Clay mask

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Mar 5, 2021

First Submission Date that Met QC Criteria

Sep 2, 2021

First Posted Date

Sep 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2021

Last Update Posted Date

Sep 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Label	Type	Intervention Names
French Green Clay Mask	Experimental	Other: Clay mask
Rhassoul Clay Mask	Experimental	Other: Clay mask
Bentonite Clay Mask	Experimental	Other: Clay mask

Name	Type	Description	Arm Group Labels	Other Names
Clay mask	Other	Clay mask powders- French green, Rhassul and bentonite	Bentonite Clay Mask French Green Clay Mask Rhassoul Clay Mask

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Count of Participants with Decrease in Skin pigmentation intensity at 4 Weeks	Computer and photography based facial image analysis	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
% of Participants with Skin redness intensity improvement at 4 weeks	Computer and photography based facial image analysis	4 weeks

Other Outcomes

Measure	Description	Time Frame
Patient tolerability survey	Survey to grade for side effects	4 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided