Photodamaged SkinNCT05908825
Placebo-Controlled Study Assessing the Use of a Novel Exfoliative Serum With A Chemical Peel to Improve Photodamage in Adults
A study testing Vitamin C with AHA Exfoliative Serum in people with Photodamaged Skin, run by Austin Institute for Clinical Research at 1 site in United States.
Trial summary
This is a split-face, double-blind, placebo-controlled study assessing the use of a novel exfoliative serum with a chemical peel to improve photodamage in healthy female subjects between the ages of 30 and 65 years, inclusive, with Fitzpatrick skin types I-VI. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photodamaged Skin
- What is being tested?
- Vitamin C with AHA Exfoliative Serum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2023to 26 Jan 2024
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female subjects aged between 30 and 65 years, inclusive
- Fitzpatrick skin type I-VI
- All skin types, including sensitive skin
- Mild to moderate severity (score of 3 to 6; modified Griffiths scale) of the following attributes on the global face:
- Smoothness, tactile and visual
- Dark spot intensity
Show all 18Show fewer
- Hyperpigmentation
- Clarity
- Radiance
- Skin tone evenness
- Firmness (visual)
- Elasticity (tactile)
- Overall healthy skin appearance
- Global fine lines
- Appearance of pores
- No known medical conditions that, in the Investigator's opinion may interfere with study participation
- Willingness to cooperate and participate by following study requirements
- Individuals must sign an informed consent and a photography consent
Who cannot join
- Subjects that are being treated for cancer or have a history of facial skin cancer on the test areas
- Subjects with sunburn, moderate to pronounced suntan, pronounced asymmetric skin aging, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results
- Subjects currently taking certain medications which in the opinion of the Investigators may interfere with the study. This includes but not limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids [steroid nose drops, inhalers and/or eye drops are permitted]), and immunosuppressive drugs
- Subjects with self-reported, uncontrolled systemic disease which, in the opinion of the Investigator, may hinder either the subject's ability to perform all responsibilities of the trial or the Investigator's ability to perform assessments
- Women known to be pregnant, nursing or planning to become pregnant
- Subjects participating in other facial clinical studies
Show all 14Show fewer
- Subjects who have routinely used an alpha-hydroxy-acid (AHA) or a beta-hydroxy-acid (BHA) containing product within two weeks or Retin-A, Retin-A Micro, Renova, Differin, Avita, Tazorac, or Soriatane within 8 weeks of the study start or have taken Isotretinoin within one year of the study start. Subjects who have used Retinol in the last 4 weeks
- Subjects with current flaring moderate to severe inflammatory acne
- Subjects who have had ablative laser treatments, microneedling, and/or chemical peels or dermabrasion within the last six months
- Subjects who have had botulinum type-A toxin (e.g. Botox®, Dysport® or Xeomin ®) within the last 3 months
- Subjects who have had dermal filler injections within the last 12 months
- Subjects who have had non-ablative laser treatments or IPL within the last 3 months
- Subjects with known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs
- Subjects currently using topically applied prescription medications on the face
Trial locations and contacts
1 site in 1 country.
United States1 site
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
About this study
Official title: A Split-Face, Double-Blind, Placebo-Controlled Study Assessing the Use of a Novel Exfoliative Serum With A Chemical Peel to Improve Photodamage
This is a split-face, double-blind, placebo-controlled study assessing the use of a novel exfoliative serum with a chemical peel to improve photodamage in healthy female subjects between the ages of 30 and 65 years, inclusive, with Fitzpatrick skin types I-VI.
Read the detailed description
A single-center study. Clinical efficacy will be assessed using the modified Griffith's scale. Instrumentation will be assessed using VISIA imaging procedures, and TEWL (transepidermal water loss). Tolerability will be assessed in subjects through objective tolerance grading and subjective tolerance assessment. In addition, subject perception of the product will be evaluated by questionnaires. Live investigator clinical efficacy grading, tolerance evaluations, and subject self-assessments; will be performed at baseline and Days 7, 14, 21, 31, and 42. Additionally instrumentation measurements of erythema and hyperpigmentation will be calculated by digital assessments of facial photographs.
All data will be collected by the clinical site and delivered to SGS in Excel files, including demographic information, clinical grading of efficacy and tolerability evaluations, Tewameter, and self-assessment questionnaire data. Data review and analyses will be performed by an independent data committee. Interim topline data will be sent to the Sponsor after Day 42. End-of-study topline data will be sent at 10 business days after study completion. A clinical study report will be drafted using an SGS report template and incorporating any documented Sponsor preferences on file with SGS. The draft report will be submitted to the Sponsor for approval prior to finalization, and revisions may be made at the Sponsor's request. SGS will submit the draft report to the Sponsor 20-30 business days after approval of all statistical analysis and receipt of study documents from the study site. Any additions and changes to the statistical analysis after study completion may delay issuance of the draft report. After receiving the draft report, the Sponsor will have 6 months to make revisions. If SGS has received no revisions or comments within 6 months, the report will be approved for finalization. Every effort will be made to send the final report to the Sponsor within 10 business days after Sponsor approval or after the 6-month period has passed.
A total of 25 subjects are planned to be enrolled. Subjects who met the specified inclusion/exclusion criteria will be randomized to receive the novel exfoliative serum on one side and placebo on the other side on Day 0 of the study. On Day 14 of the study, each subject will receive a chemical peel as deemed appropriate by the Investigator and based on Fitzpatrick skin type. The chemical peel will be either TCA SmartPeel or Micropeel 30, per Investigator prerogative based on subject's skin sensitivity. For subject with Fitzpatrick Skin Type of IV-VI will receive the Micropeel. Following the chemical peel all subjects will discontinue use of the placebo and novel exfoliative serum. On Day 21, facial skin will be examined by the Investigator in-office to determine if each subject may resume the Day 0 randomized treatment regimen. All evaluations will be done in a double-blind fashion. Clinical efficacy endpoints will be evaluated on Days 7, 14, 21, 31 and 42. Tolerance endpoints will be evaluated on Days 14, 21, 31 and 42. In addition, tolerability will be evaluated on Day 16 via tele-visit (phone call). Physician assessments, patient-reported outcomes, and digital assessments of photographs will be captured during this study.
A subject may be discontinued from study treatment at any time if the subject, the Investigator, or the Sponsor feels that it is not in the subject's best interest to continue. If a subject is withdrawn from treatment due to an AE, the subject will be followed and treated by the Investigator until the abnormal parameter or symptom has resolved or stabilized.
All subjects who discontinue study treatment should come in for an early discontinuation visit as soon as possible and then should be encouraged to complete all remaining scheduled visits and procedures. All subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. If a subject withdraws prior to or during the procedure, an additional subject may be enrolled to replace the withdrawn subject. The sponsor may elect to close the trial at any time during the course of the study. Any data collected prior to termination may be analyzed as specified in the protocol.
The Investigator will probe, via discussion with the subject, for the occurrence of AEs (adverse events) during each subject visit and record the information in the site's source documents. Adverse events will be recorded in the subject CRF (case report form). Adverse events will be described by duration (start and stop dates and times), severity, outcome, treatment and relation to study drug, or if unrelated, the cause. Study site will document all SAEs (serious adverse events) that occur (whether or not related to study treatment). The collection period for all SAEs will begin after informed consent is obtained and end after procedures for the final study visit have been completed.
- Conditions
- Photodamaged Skin
- Being tested
- Vitamin C with AHA Exfoliative Serum, Placebo serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C with AHA Exfoliative SerumDrug
Also called Skinceuticals C + AHA
Catalyst is a novel skincare product comprised of low concentrations of multiple hydroxy acids and will be randomly assigned as Product A or Product B to be applied to one side of the face.
Placebo serumDrug
Placebo serum will be randomly assigned as Product A or Product B to be applied to one side of the face.
| Study group | Role | What they receive |
|---|---|---|
| 20 day application of study product A and B | Other | Subjects will be given study drug and instructed to topically apply to the treatment area, Study Product A or Study Product B, placebo serum or novel exfoliative serum, to the respectively randomized half of the face, once daily for 20 consecutive days. Receives: Drug: Vitamin C with AHA Exfoliative Serum; Drug: Placebo serum |
| 42 day application of study product A and B | Other | Subjects who the investigator decides to continue treatment at Day 21, will be given study drug and instructed to topically apply to the treatment area, Study Product A or Study Product B, placebo serum or novel exfoliative serum, to the respectively randomized half of the face, once daily for an additional 21 consecutive days. Receives: Drug: Vitamin C with AHA Exfoliative Serum; Drug: Placebo serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Product tolerability
Product tolerability will be measured using the clinical grading of tolerance by evaluating the subjects reported local facial cutaneous tolerability including burning, stinging, and itching. Each scale will be measured with the following parameters, 0 = none (best possible outcome), 1 = mild, 2 = moderate, and 3 = severe (worst possible outcome). A decrease in scores or lack of significant increase indicates tolerability of the study treatment. The null hypothesis is that the mean change from baseline is zero.
Measured: Change from Baseline at Day 42
Change in Product efficacy
Live Clinical Investigator grading of facial fine lines efficacy grading by using the modified Griffith's Photonumeric scale. The grading scale includes fine lines, crepiness, firmness, elasticity, smoothness, pore size, clarity, pigmentation, dark spot intensity, and skin tone evenness. The parameters for the scale are as follows, 0 = none (best possible outcome), 1 to 3 = mild, 4 to 6 = moderate, and 7 to 9 = severe (worst possible outcome). A decrease in scores indicates an improvement in study treatment efficacy. The null hypothesis is that the mean change from baseline is zero.
Measured: Change from Baseline at Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start22 Jun 2023
- Primary completion16 Nov 2023
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamaged SkinStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Institute for Clinical Research
- Sponsor type
- Research network
- Collaborators
- SkinCeuticals
- Responsible party
- Principal investigator, Edward Lain, MD, Austin Institute for Clinical Research
- Investigators
- Edward Lain, MD, MBA, Principal investigator, Austin Institute for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908825
- Sponsor's protocol ID
- CATALYST-001
- Status last verified
- Jul 2024
- First submitted
- 10 May 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split-Face, Double-Blind, Placebo-Controlled Study Assessing the Use of a Novel Exfoliative Serum With A Chemical Peel to Improve Photodamage
- ClinicalTrials.gov ID
- NCT05908825
- Acronym / sponsor ID
- CATALYST-001
- Conditions
- Photodamaged Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Austin Institute for Clinical ResearchResearch network
- Collaborators
- SkinCeuticals
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 18 Jun 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.
This is a split-face, double-blind, placebo-controlled study assessing the use of a novel exfoliative serum with a chemical peel to improve photodamage in healthy female subjects between the ages of 30 and 65 years, inclusive, with Fitzpatrick skin types I-VI.
Detailed description
A single-center study. Clinical efficacy will be assessed using the modified Griffith's scale. Instrumentation will be assessed using VISIA imaging procedures, and TEWL (transepidermal water loss). Tolerability will be assessed in subjects through objective tolerance grading and subjective tolerance assessment. In addition, subject perception of the product will be evaluated by questionnaires. Live investigator clinical efficacy grading, tolerance evaluations, and subject self-assessments; will be performed at baseline and Days 7, 14, 21, 31, and 42. Additionally instrumentation measurements of erythema and hyperpigmentation will be calculated by digital assessments of facial photographs.
All data will be collected by the clinical site and delivered to SGS in Excel files, including demographic information, clinical grading of efficacy and tolerability evaluations, Tewameter, and self-assessment questionnaire data. Data review and analyses will be performed by an independent data committee. Interim topline data will be sent to the Sponsor after Day 42. End-of-study topline data will be sent at 10 business days after study completion. A clinical study report will be drafted using an SGS report template and incorporating any documented Sponsor preferences on file with SGS. The draft report will be submitted to the Sponsor for approval prior to finalization, and revisions may be made at the Sponsor's request. SGS will submit the draft report to the Sponsor 20-30 business days after approval of all statistical analysis and receipt of study documents from the study site. Any additions and changes to the statistical analysis after study completion may delay issuance of the draft report. After receiving the draft report, the Sponsor will have 6 months to make revisions. If SGS has received no revisions or comments within 6 months, the report will be approved for finalization. Every effort will be made to send the final report to the Sponsor within 10 business days after Sponsor approval or after the 6-month period has passed.
A total of 25 subjects are planned to be enrolled. Subjects who met the specified inclusion/exclusion criteria will be randomized to receive the novel exfoliative serum on one side and placebo on the other side on Day 0 of the study. On Day 14 of the study, each subject will receive a chemical peel as deemed appropriate by the Investigator and based on Fitzpatrick skin type. The chemical peel will be either TCA SmartPeel or Micropeel 30, per Investigator prerogative based on subject's skin sensitivity. For subject with Fitzpatrick Skin Type of IV-VI will receive the Micropeel. Following the chemical peel all subjects will discontinue use of the placebo and novel exfoliative serum. On Day 21, facial skin will be examined by the Investigator in-office to determine if each subject may resume the Day 0 randomized treatment regimen. All evaluations will be done in a double-blind fashion. Clinical efficacy endpoints will be evaluated on Days 7, 14, 21, 31 and 42. Tolerance endpoints will be evaluated on Days 14, 21, 31 and 42. In addition, tolerability will be evaluated on Day 16 via tele-visit (phone call). Physician assessments, patient-reported outcomes, and digital assessments of photographs will be captured during this study.
A subject may be discontinued from study treatment at any time if the subject, the Investigator, or the Sponsor feels that it is not in the subject's best interest to continue. If a subject is withdrawn from treatment due to an AE, the subject will be followed and treated by the Investigator until the abnormal parameter or symptom has resolved or stabilized.
All subjects who discontinue study treatment should come in for an early discontinuation visit as soon as possible and then should be encouraged to complete all remaining scheduled visits and procedures. All subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. If a subject withdraws prior to or during the procedure, an additional subject may be enrolled to replace the withdrawn subject. The sponsor may elect to close the trial at any time during the course of the study. Any data collected prior to termination may be analyzed as specified in the protocol.
The Investigator will probe, via discussion with the subject, for the occurrence of AEs (adverse events) during each subject visit and record the information in the site's source documents. Adverse events will be recorded in the subject CRF (case report form). Adverse events will be described by duration (start and stop dates and times), severity, outcome, treatment and relation to study drug, or if unrelated, the cause. Study site will document all SAEs (serious adverse events) that occur (whether or not related to study treatment). The collection period for all SAEs will begin after informed consent is obtained and end after procedures for the final study visit have been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 day application of study product A and B | Other | Drug: Vitamin C with AHA Exfoliative Serum, Drug: Placebo serumSubjects will be given study drug and instructed to topically apply to the treatment area, Study Product A or Study Product B, placebo serum or novel exfoliative serum, to the respectively randomized half of the face, once daily for 20 consecutive days. |
| 42 day application of study product A and B | Other | Drug: Vitamin C with AHA Exfoliative Serum, Drug: Placebo serumSubjects who the investigator decides to continue treatment at Day 21, will be given study drug and instructed to topically apply to the treatment area, Study Product A or Study Product B, placebo serum or novel exfoliative serum, to the respectively randomized half of the face, once daily for an additional 21 consecutive days. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Healthy female subjects aged between 30 and 65 years, inclusive
- Fitzpatrick skin type I-VI
- All skin types, including sensitive skin
- Mild to moderate severity (score of 3 to 6; modified Griffiths scale) of the following attributes on the global face:
- No known medical conditions that, in the Investigator's opinion may interfere with study participation
Key exclusion criteria (14 listed)
- Subjects that are being treated for cancer or have a history of facial skin cancer on the test areas
- Subjects with sunburn, moderate to pronounced suntan, pronounced asymmetric skin aging, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results
- Subjects currently taking certain medications which in the opinion of the Investigators may interfere with the study. This includes but not limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids [steroid nose drops, inhalers and/or eye drops are permitted]), and immunosuppressive drugs
- Subjects with self-reported, uncontrolled systemic disease which, in the opinion of the Investigator, may hinder either the subject's ability to perform all responsibilities of the trial or the Investigator's ability to perform assessments
- Women known to be pregnant, nursing or planning to become pregnant
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 |
|---|---|---|
| Vitamin C with AHA Exfoliative SerumAlso: Skinceuticals C + AHACatalyst is a novel skincare product comprised of low concentrations of multiple hydroxy acids and will be randomly assigned as Product A or Product B to be applied to one side of the face. | Drug | 20 day application of study product A and B, 42 day application of study product A and B |
| Placebo serumPlacebo serum will be randomly assigned as Product A or Product B to be applied to one side of the face. | Drug | 20 day application of study product A and B, 42 day application of study product A and B |
Primary outcome
Change in Product tolerability
Time frame: Change from Baseline at Day 42
Product tolerability will be measured using the clinical grading of tolerance by evaluating the subjects reported local facial cutaneous tolerability including burning, stinging, and itching. Each scale will be measured with the following parameters, 0 = none (best possible outcome), 1 = mild, 2 = moderate, and 3 = severe (worst possible outcome). A decrease in scores or lack of significant increase indicates tolerability of the study treatment. The null hypothesis is that the mean change from baseline is zero.
Change in Product efficacy
Time frame: Change from Baseline at Day 42
Live Clinical Investigator grading of facial fine lines efficacy grading by using the modified Griffith's Photonumeric scale. The grading scale includes fine lines, crepiness, firmness, elasticity, smoothness, pore size, clarity, pigmentation, dark spot intensity, and skin tone evenness. The parameters for the scale are as follows, 0 = none (best possible outcome), 1 to 3 = mild, 4 to 6 = moderate, and 7 to 9 = severe (worst possible outcome). A decrease in scores indicates an improvement in study treatment efficacy. The null hypothesis is that the mean change from baseline is zero.
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 19 Jul 2024.
Related trials for Photodamaged Skin
Recruiting
Multimodal Laser Treatment of Photodamaged Skin
Photo-damage, Actinic Keratosis (AK)
Not yet recruitingPhase 2/3
Study Comparing Two Serums With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms
Photodamaged Skin
Not yet recruiting
A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery
Photodamaged Skin, Skin Cancer Prevention
Recruiting
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Photodamaged Skin, Rhytids
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.
Edward Lain, MD, MBA principal investigator
Austin Institute for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C with AHA Exfoliative Serum in people with Photodamaged Skin, run by Austin Institute for Clinical Research 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 18 inclusion and 14 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 19 Jul 2024. 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?
Change in Product tolerability (time frame: Change from Baseline at Day 42). 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?
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 19 Jul 2024.