Anti-agingNCT06148558
A Twelve Week Clinical Study to Evaluate the Efficacy and Tolerability of a Sunscreen Moisturizer SPF 50+
A study testing Sunscreen Moisturizer, Gentle Cleansing Lotion and Facial Moisturizer in people with Anti-aging and Photoaging, run by Revision Skincare at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy and tolerance of a moisturizer SPF 50+ when used over a 12-week time period by women with moderate to severe facial photodamage. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anti-aging, Photoaging
- What is being tested?
- Sunscreen Moisturizer, Gentle Cleansing Lotion and Facial Moisturizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to 9 Feb 2023
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 35 and 60 years
- Women with Fitzpatrick skin type I-VI
- Subjects must have moderate to severe overall facial photodamage
- Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must be willing to provide verbal understanding and written informed consent.
Who cannot join
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients in the study product(s).
- Subjects who are currently under a physician's care for a medical problem that, in the opinion of the Investigator or his designee, could affect the subject's treatment response.
- Subjects who are nursing, pregnant, or planning a pregnancy during this study
- Subjects who have a health condition and/or pre-existing or dormant dermatologic disease on the face
- Subjects who are not willing to avoid daily sun exposure on their face and the use of tanning beds or sunless tanning products during the duration of the study.
- Is currently taking or have taken within the listed time frame prior to the start of the study: Oral isotretinoin (Accutane®) within the last 6 months; Avita®, Differin®, Renova®, Retin-A®, Retin-A Micro®, Soriatane®, or Tazorac® within 3 months; Prescription-strength skin-lightening products within 4 months; Any anti-wrinkle, skin-lightening, or other product or topical or systemic medication known to affect skin aging or dyschromia within 2 weeks; Had a non-ablative laser (Including IPL) or non-ablative fractional laser resurfacing of the face and neck within 6 months
- Has any other condition that, in the opinion of the Investigator or his designee, could interfere with the subject's ability to use the treatment as instructed, alter treatment response, or affect their ability to complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Study Center, KGL LLC
Newtown Square, Pennsylvania, 19073
About this study
Official title: A Twelve Week Clinical Study to Evaluate the Efficacy and Tolerability of a Sunscreen Moisturizer SPF 50+ in Women With Moderate to Severe Overall Photodamage
The primary objective of this study is to evaluate the efficacy and tolerance of a moisturizer SPF 50+ when used over a 12-week time period by women with moderate to severe facial photodamage.
Read the detailed description
This was a single center, single-cell, 12-week clinical trial on female subjects (Fitzpatrick Skin Type I-VI, evenly distributed) between 35-60 years of age with moderate to severe overall facial photodamage. All subjects were provided Revision Skincare Gentle Foaming Cleanser and Facial Moisturizer (Goodier Cosmetics) at the Screening visit after eligibility was confirmed. These products were used twice daily as instructed for a minimum 3 days prior to the Baseline visit (washout phase). At Baseline, subjects were given Sunscreen Moisturizer SPF 50+ to replace their Facial Moisturizer morning application. Subjects continued to use the Facial Moisturizer given at Screening in the evening.
Clinical grading assessments, full face images, Corneometer, Ultrasound, and subject self-assessment questionnaires were completed at each study visit (Baseline, Week 4, 8, and 12). Full face images were also completed post-application at Baseline.
A total of 34 subjects completed the study.
- Conditions
- Anti-aging, Photoaging
- Being tested
- Sunscreen Moisturizer, Gentle Cleansing Lotion, Facial Moisturizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunscreen MoisturizerOther
A provided anti-aging sunscreen moisturizer SPF 50 was used once a day.
Gentle Cleansing LotionOther
A provided Gentle Cleansing Lotion (Revision Skincare) was used 2x daily (AM/PM).
Facial MoisturizerOther
A provided facial moisturizer (Goodier) was used 1x daily (PM).
| Study group | Role | What they receive |
|---|---|---|
| Single-Cell | Other | Not described Receives: Other: Sunscreen Moisturizer; Other: Gentle Cleansing Lotion; Other: Facial Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Clinical Efficacy Parameters at weeks 4, 8, and 12 versus Baseline
The primary efficacy endpoint will be Investigator Clinical Grading using a Modified Griffiths' 10-point scale. The scale ranges from 0 = none (best possible condition) to 9 = severe (worst possible condition). A decrease in score at post-baseline timepoints compared to baseline indicates an improvement. The parameters are fine lines (global face), wrinkles (global face), global hyperpigmentation (mottled and discrete), skin roughness (tactile), skin tone evenness (uniformity of skin color), overall photodamage, radiance (perceived glow), and skin firmness (tactile).
Measured: 12 weeks
Secondary outcomes (2)
Lack of significant increase in Objective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline
The primary tolerability endpoint will be the Investigator Tolerability Assessment of erythema, edema, and scaling/peeling of the face and neck. The 4-point scale ranges from 0 = none to 3 = severe. A decrease in score at post-baseline timepoints compared to baseline indicates an improvement.
Measured: 12 weeks
Lack of significant increase in Subjective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline
The secondary tolerability endpoint will be the Subjective Tolerability Assessment of burning/stinging, itching, and tightness/dryness of the face and neck. The 4-point scale ranges from 0 = none to 3 = severe. A decrease in score at post-baseline timepoints compared to baseline indicates an improvement.
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 posted28 Nov 2023
- Study start9 Nov 2022
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-agingStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, 12-week study. 39 female subjects were recruited, 35 to 60 years, Fitzpatrick Skin Type I-VI, with moderate-severe overall facial photodamage.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148558
- Sponsor's protocol ID
- 8674
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve Week Clinical Study to Evaluate the Efficacy and Tolerability of a Sunscreen Moisturizer SPF 50+ in Women With Moderate to Severe Overall Photodamage
- ClinicalTrials.gov ID
- NCT06148558
- Acronym / sponsor ID
- 8674
- Conditions
- Anti-aging, Photoaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 28 Nov 2023 (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.
The primary objective of this study is to evaluate the efficacy and tolerance of a moisturizer SPF 50+ when used over a 12-week time period by women with moderate to severe facial photodamage.
Detailed description
This was a single center, single-cell, 12-week clinical trial on female subjects (Fitzpatrick Skin Type I-VI, evenly distributed) between 35-60 years of age with moderate to severe overall facial photodamage. All subjects were provided Revision Skincare Gentle Foaming Cleanser and Facial Moisturizer (Goodier Cosmetics) at the Screening visit after eligibility was confirmed. These products were used twice daily as instructed for a minimum 3 days prior to the Baseline visit (washout phase). At Baseline, subjects were given Sunscreen Moisturizer SPF 50+ to replace their Facial Moisturizer morning application. Subjects continued to use the Facial Moisturizer given at Screening in the evening.
Clinical grading assessments, full face images, Corneometer, Ultrasound, and subject self-assessment questionnaires were completed at each study visit (Baseline, Week 4, 8, and 12). Full face images were also completed post-application at Baseline.
A total of 34 subjects completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, 12-week study. 39 female subjects were recruited, 35 to 60 years, Fitzpatrick Skin Type I-VI, with moderate-severe overall facial photodamage.
| Arm | Type | Receives |
|---|---|---|
| Single-Cell | Other | Other: Sunscreen Moisturizer, Other: Gentle Cleansing Lotion, Other: Facial Moisturizer |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between the ages of 35 and 60 years
- Women with Fitzpatrick skin type I-VI
- Subjects must have moderate to severe overall facial photodamage
- Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must be willing to provide verbal understanding and written informed consent.
Key exclusion criteria (7 listed)
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients in the study product(s).
- Subjects who are currently under a physician's care for a medical problem that, in the opinion of the Investigator or his designee, could affect the subject's treatment response.
- Subjects who are nursing, pregnant, or planning a pregnancy during this study
- Subjects who have a health condition and/or pre-existing or dormant dermatologic disease on the face
- Subjects who are not willing to avoid daily sun exposure on their face and the use of tanning beds or sunless tanning products during the duration of the study.
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 |
|---|---|---|
| Sunscreen MoisturizerA provided anti-aging sunscreen moisturizer SPF 50 was used once a day. | Other | Single-Cell |
| Gentle Cleansing LotionA provided Gentle Cleansing Lotion (Revision Skincare) was used 2x daily (AM/PM). | Other | Single-Cell |
| Facial MoisturizerA provided facial moisturizer (Goodier) was used 1x daily (PM). | Other | Single-Cell |
Primary outcome
Improvement in Clinical Efficacy Parameters at weeks 4, 8, and 12 versus Baseline
Time frame: 12 weeks
The primary efficacy endpoint will be Investigator Clinical Grading using a Modified Griffiths' 10-point scale. The scale ranges from 0 = none (best possible condition) to 9 = severe (worst possible condition). A decrease in score at post-baseline timepoints compared to baseline indicates an improvement. The parameters are fine lines (global face), wrinkles (global face), global hyperpigmentation (mottled and discrete), skin roughness (tactile), skin tone evenness (uniformity of skin color), overall photodamage, radiance (perceived glow), and skin firmness (tactile).
2 secondary outcomes
Lack of significant increase in Objective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline
Time frame: 12 weeks
Lack of significant increase in Subjective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline
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 28 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunscreen Moisturizer, Gentle Cleansing Lotion and Facial Moisturizer in people with Anti-aging and Photoaging, run by Revision Skincare 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 5 inclusion and 7 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 28 Nov 2023. 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?
Improvement in Clinical Efficacy Parameters at weeks 4, 8, and 12 versus Baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.