PhotoagingNCT04345094
Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging
A study testing Hexylresourcinol and Hydroquinone in people with Photoaging, run by Sytheon Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Hexylresourcinol and Hydroquinone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 15 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative skin Science and Research
Sacramento, California, 95815
About this study
Official title: Randomized, Double-Blind 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.
- Conditions
- Photoaging
- Being tested
- Hexylresourcinol, Hydroquinone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HexylresourcinolOther
Emulsion containing hexylresorcinol as an active
HydroquinoneOther
Emulsions containing hydroquinone as an active
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Experimental | Emulsion containing 1% Hexylresourcinol Receives: Other: Hexylresourcinol |
| Intervention | Active comparator | Emulsion containing 2% Hydroquinone Receives: Other: Hydroquinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Secondary outcomes (1)
Observe and assess changes in the appearance of skin redness
Assessed using skin colorimeter (validated measurement tool) - by erythema measurement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Jul 2019
- Primary completion24 Dec 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sytheon Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ratan K. Chaudhuri, Sytheon Ltd.
- Investigators
- Raja Sivamani, MD, Principal investigator, Pacific Skin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345094
- Sponsor's protocol ID
- HHSOL-1495-125
- Status last verified
- Jul 2020
- First submitted
- 26 Mar 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published in a scientific journal with raw data made available to researchers upon request.
Publications
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.
PubMed 36502500
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging
- ClinicalTrials.gov ID
- NCT04345094
- Acronym / sponsor ID
- HHSOL-1495-125
- Conditions
- Photoaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sytheon Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Experimental | Other: HexylresourcinolEmulsion containing 1% Hexylresourcinol |
| Intervention | Active comparator | Other: HydroquinoneEmulsion containing 2% Hydroquinone |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- • Individuals who have been on any medication that has caused a change in skin pigmentation based on the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HexylresourcinolEmulsion containing hexylresorcinol as an active | Other | Comparator |
| HydroquinoneEmulsions containing hydroquinone as an active | Other | Intervention |
Primary outcome
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.
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.
1 secondary outcome
Observe and assess changes in the appearance of skin redness
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Derived from this study: PubMed 36502500Wu 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.
- Individual participant dataSharing planned: No. Data will be published in a scientific journal with raw data made available to researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja Sivamani, MD principal investigator
Pacific Skin Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hexylresourcinol and Hydroquinone in people with Photoaging, run by Sytheon Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04345094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.