Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging

NCT ID: NCT04345094

Last Updated: 2020-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Photoaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Comparator

Emulsion containing 1% Hexylresourcinol

Group Type EXPERIMENTAL

Hexylresourcinol

Intervention Type OTHER

Emulsion containing hexylresorcinol as an active

Intervention

Emulsion containing 2% Hydroquinone

Group Type ACTIVE_COMPARATOR

Hydroquinone

Intervention Type OTHER

Emulsions containing hydroquinone as an active

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hexylresourcinol

Emulsion containing hexylresorcinol as an active

Intervention Type OTHER

Hydroquinone

Emulsions containing hydroquinone as an active

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sytheon Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ratan K. Chaudhuri

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raja Sivamani, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Skin Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Integrative skin Science and Research

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Wu H, Gabriel TA, Burney WA, Chambers CJ, Pan A, Sivamani RK. Prospective, randomized, double-blind clinical study of split-body comparison of topical hydroquinone and hexylresorcinol for skin pigment appearance. Arch Dermatol Res. 2023 Jul;315(5):1207-1214. doi: 10.1007/s00403-022-02514-0. Epub 2022 Dec 11.

Reference Type DERIVED
PMID: 36502500 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HHSOL-1495-125

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RHA Redensity - Perioral Rhytids
NCT03092219 COMPLETED NA