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Completed

NCT Number: NCT04345094

Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging

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.

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Key information

Conditions

Photoaging

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Integrative skin Science and Research

Sacramento, California, 95815, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hexylresourcinol

Other

Emulsion containing hexylresorcinol as an active

Hydroquinone

Other

Emulsions containing hydroquinone as an active

Primary outcomes

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

Secondary outcomes

  1. Observe and assess changes in the appearance of skin redness

    Time frame: 12 weeks

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

Other outcomes

  1. Subjective Tolerability Assessment

    Time frame: Assessed at Week 4, 8, and 12

    Assessed through subjective questionnaire

Sponsors and collaborators

Lead sponsor

Sytheon Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 14, 2020
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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