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Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging

Primary Purpose

Photoaging

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hexylresourcinol

Hydroquinone

About this trial

This is an interventional treatment trial for Photoaging

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Females aged 35-65 (limiting to females so that there is not heterogeneity with the influence of hormones. Also, females are a much larger user base of skin care products)
Individuals who have not participated in any other clinical studies using the same test sites (face) and hand in the past 14 days
Individuals with Fitzpatrick skin type I-IV
No known medical conditions that, in the investigator's opinion, may interfere with study participation.

Exclusion Criteria:

• Individuals who have been on any medication that has caused a change in skin pigmentation based on the opinion of the investigator
- 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
- Female volunteers who are pregnant or are actively breastfeeding or planning a pregnancy within two months. (There is no concern for risk to fetus but pregnancy can alter skin pigmentation)
- 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 30 days have used hydroquinone, or a retinoid such as Retin A, or other Rx/OTC Retinyl A.
- Individuals who have used salicyclic acid, beta hydroxy acid, vitamins A, C, E in the 14 days prior to first visit.
- Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed
- Individuals who are pregnant, breast feeding or planning a pregnancy.
- Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator

Sites / Locations

Integrative skin Science and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comparator

Intervention

Arm Description

Emulsion containing 1% Hexylresourcinol

Emulsion containing 2% Hydroquinone

Outcomes

Primary Outcome Measures

To assess the use of topical hexylresorcinol versus hydroquinone skin regimen on the objective appearance of skin photoaging - specifically appearance of pigment.

Assessed Through Skin Colorimeter (Validated Measurement Tool) - by melanin measurement on cheeks, hands, and face.

To assess the use of topical hexylresorcinol versus hydroquinone skin regimen on the clinical grading of appearance of skin photoaging - specifically appearance of pigment.

Pigment was assessed through clinical grading of 0 (none) to 3 (severe) scale by board-certified dermatologist of each side of the face.

Secondary Outcome Measures

Observe and assess changes in the appearance of skin redness

Assessed using skin colorimeter (validated measurement tool) - by erythema measurement

Full Information

NCT ID

NCT04345094

First Posted

March 26, 2020

Last Updated

July 8, 2020

Sponsor

Sytheon Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04345094

Brief Title

Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging

Official Title

Randomized, Double-Blind Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

December 24, 2019 (Actual)

Study Completion Date

February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sytheon Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Photoaging is a common concern within the cosmeceutical industry with many products that are available. One frequently used product is hydroquinone that is used to even skin tone. However, hydroquinone has several shortcomings. The ingredient is controversial for its potential safety issues and it has been banned in Europe. An alternative ingredient that has emerged for its potential use is hexyresorcinol for evening skin tone. Additionally, hexylresorcinol may have other photoaging benefits such as the reduction in the appearance of fine lines. Therefore, the aim of this study is to assess how hexyresorcinol may compare to the use of hydroquinone in the setting of photoaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Photoaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Comparator

Arm Type

Experimental

Arm Description

Emulsion containing 1% Hexylresourcinol

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

Emulsion containing 2% Hydroquinone

Intervention Type

Other

Intervention Name(s)

Hexylresourcinol

Intervention Description

Emulsion containing hexylresorcinol as an active

Intervention Type

Other

Intervention Name(s)

Hydroquinone

Intervention Description

Emulsions containing hydroquinone as an active

Primary Outcome Measure Information:

Title

To assess the use of topical hexylresorcinol versus hydroquinone skin regimen on the objective appearance of skin photoaging - specifically appearance of pigment.

Description

Assessed Through Skin Colorimeter (Validated Measurement Tool) - by melanin measurement on cheeks, hands, and face.

Time Frame

12 weeks

Title

To assess the use of topical hexylresorcinol versus hydroquinone skin regimen on the clinical grading of appearance of skin photoaging - specifically appearance of pigment.

Description

Pigment was assessed through clinical grading of 0 (none) to 3 (severe) scale by board-certified dermatologist of each side of the face.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Observe and assess changes in the appearance of skin redness

Description

Assessed using skin colorimeter (validated measurement tool) - by erythema measurement

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Subjective Tolerability Assessment

Description

Assessed through subjective questionnaire

Time Frame

Assessed at Week 4, 8, and 12

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Females aged 35-65 (limiting to females so that there is not heterogeneity with the influence of hormones. Also, females are a much larger user base of skin care products) Individuals who have not participated in any other clinical studies using the same test sites (face) and hand in the past 14 days Individuals with Fitzpatrick skin type I-IV No known medical conditions that, in the investigator's opinion, may interfere with study participation. Exclusion Criteria: • Individuals who have been on any medication that has caused a change in skin pigmentation based on the opinion of the investigator 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 Female volunteers who are pregnant or are actively breastfeeding or planning a pregnancy within two months. (There is no concern for risk to fetus but pregnancy can alter skin pigmentation) 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 30 days have used hydroquinone, or a retinoid such as Retin A, or other Rx/OTC Retinyl A. Individuals who have used salicyclic acid, beta hydroxy acid, vitamins A, C, E in the 14 days prior to first visit. Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed Individuals who are pregnant, breast feeding or planning a pregnancy. Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raja Sivamani, MD

Organizational Affiliation

Pacific Skin Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Integrative skin Science and Research

City

Sacramento

State/Province

California

ZIP/Postal Code

95815

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will be published in a scientific journal with raw data made available to researchers upon request.

Learn more about this trial

Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging

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