Skin ManifestationsNCT02422836
Tolerability and Efficacy of Anti-Aging Treatment Regimen in Subjects With Photodamage
A study testing Three Product Anti-Aging Treatment Regimen in people with Skin Manifestations, run by US CosmeceuTechs, LLC.
Trial summary
The subjects will use the test skincare products. This is a full face, twice daily application study, with digital photos and expert grader evaluations at Baseline, 4 and 8 week periods. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Manifestations
- What is being tested?
- Three Product Anti-Aging Treatment Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to May 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be diagnosed by the investigator or expert grader to have moderate to severe lines/wrinkles (Grade 3 or higher, determined by the Glogau Scale).
- Subjects must be 35 - 65 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Sexually active females of childbearing potential participating in the study must agree to use a medically-acceptable method of contraception while receiving study product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Exception: Sexually inactive females of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the investigator's discretion, provided that they understand the possible risks involved in getting pregnant during the study and are counseled to remain sexually inactive for the duration of the study or to practice a reliable method of contraception if becoming sexually active during the study.
- Subjects must sign a written informed consent.
Who cannot join
- Any dermatologic disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's facial skin. Examples of such disorders include severe acne vulgaris, acne conglobata, acne fulminans, facial seborrheic dermatitis, and lupus erythematosus.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Concurrent therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.
- Subjects who are not willing to discontinue their normal facial cosmetics during the study period. The subjects' dry mineral foundation and eye make-up are permitted, no liquid foundation; no other facial products other than the provided skincare products may be used.
- Subjects who have used anti-aging skincare products (cosmetic and drug products with any of the following ingredients: AHA, Salicylic Acid, Vitamins A, Retin-A, Vitamin C, Growth Factors or Peptides, Antioxidants such as Idebenone, CoffeeBerry, CE Ferulic, Phloretin, etc.) within the last 3 months and during the course of the study.
- Subjects with recent history in the past 6 months and during the course of the study of laser, chemical peels, microdermabrasion, or other medical treatments for the skin for anti-aging.
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- Subjects who are pregnant, breast feeding or planning a pregnancy during the study period.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
- No sun-bathing, use of sun lamps or tanning beds is permitted during the entire duration of the study.
- Participation in another research study (currently or within the last 30 days).
- All volunteers will sign the consent forms after being informed as to their obligations and risks that they might encounter as a participant in this study.
About this study
Official title: The Tolerability and Efficacy of a Three Product Anti-Aging Treatment Regimen in Subjects With Moderate to Severe Photodamage
The subjects will use the test skincare products. This is a full face, twice daily application study, with digital photos and expert grader evaluations at Baseline, 4 and 8 week periods. If the subject meets the study criteria and is enrolled, they will be instructed at screening visit to discontinue the use of any facial products (except dry mineral foundation and eye make-up) for seven (7) days before beginning the study (referred to as the "washout" period). They will return to the site for the baseline visit 2 after the required 7 day washout period (visit can occur within 1 week after screening visit).
Read the detailed description
After the subjects properly consent to participation and are determined eligible, the study coordinator will review the subjects' medical history and obtain demographics. The Principal Investigator (PI) or designee (expert grader) will examine the subjects to determine their appropriateness for study inclusion.
At the Screening visit (Visit 1, Day -10 to -7), the subjects will be assessed by the PI or designee to confirm inclusion into the study. Expert grading and Canfield VISIA CR photographic documentation (all flash modes including RBX) will be performed at baseline (Visit 2, Day 0), Week 4 (Visit 3, Day 28 ± 7 days), and Week 8 (Visit 4, Day 56 ± 7 days).
Subjects who, in the PI's or designee's opinion, appear to be experiencing product related adverse reactions may be discontinued at any time during the study. The subjects' home care treatment products (the items included in the kit) will be performed at home, at the times and in the manner described in the instructions provided.
- Conditions
- Skin Manifestations
- Being tested
- Three Product Anti-Aging Treatment Regimen
- Keywords
- photodamage, fine lines, wrinkles, dyschromia
- Medical subject headings
- Skin Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three Product Anti-Aging Treatment RegimenOther
Also called Anti-aging Cream, Sunscreen SPF 50, Cream Skin Cleanser
Cream Skin Cleanser RD04033B, twice daily, 8 weeks; Anti-aging Cream RD04034B, twice daily, 8 weeks; and Sunscreen SPF 50 RD04036, once daily, reapply as needed, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Three Product Anti-Aging Regimen | Experimental | Three Product Anti-Aging Treatment Regimen:
Cream Skin Cleanser RD04033B, twice daily, 8 weeks; Anti-aging Cream RD04034B, twice daily, 8 weeks; and Sunscreen SPF 50 RD04036, once daily, reapply as needed, 8 weeks Receives: Other: Three Product Anti-Aging Treatment Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glogau Photodamage Scale: the change between the photodamage grade at Week 4 and Week 8 compared to the photodamage grade at the Baseline Visit.
The Glogau Photodamage Scale (Type I: No wrinkles, Type II: Wrinkles in motion, Type III: Wrinkles at rest, Type IV: Only wrinkles) represents a qualitative assessment to measure the severity of photodamage and wrinkles. Photodamage was graded at the Screening Visit (Day -10 to Day -7), Baseline Visit (Day 0), Week 4 Visit (Day 28), and Week 8 Visit (Day 56). The endpoint that was used to evaluate the primary objective of the study is the delta (change) between the photodamage grade at Week 4 Visit (Day 28) and Week 8 Visit (Day 56) compared to the photodamage grade at the Baseline Visit.
Measured: 8 weeks
Secondary outcomes (3)
Dryness and Flaking: the change between the dryness grade at Week 4 and Week 8 compared to the dryness grade at the Baseline Visit.
This parameter represents a visual assessment of skin dryness from normal skin (0/no dryness) to very severe dryness (5). Additionally, very marked visual flaking; very coarse scaling; cracking progressing to fissuring; marked thickening may be present.
Measured: 8 weeks
Dyschromia: the change between the dyschromia grade at Week 4 and Week 8 compared to the dyschromia grade at the Baseline Visit.
This parameter represents a qualitative assessment of skin pigmentation from Normal (grade 0) to Severe (grade 5). Textural features likely to contribute to this grade include both red and brown patches of discoloration and other surface irregularities.
Measured: 8 weeks
Stinging and Burning: the change between the stinging grade at Week 4 and Week 8 compared to the stinging grade at the Baseline Visit.
This parameter represents an assessment of any stinging or burning and relative duration of the sensation experienced by the subject when questioned by the Expert Grader. A scale of 0 to 5 as noted above can used to describe these findings when present.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
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 Skin ManifestationsStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- US CosmeceuTechs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Katz, MD, Principal investigator, JUVA Skin & Laser Center / MediSpa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422836
- Sponsor's protocol ID
- USC-06-13.1
- Status last verified
- Apr 2015
- First submitted
- 8 Apr 2015
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Katz BE, Lewis J, McHugh L, Pellegrino A, Popescu L. The Tolerability and Efficacy of a Three-product Anti-aging Treatment Regimen in Subjects with Moderate-to-severe Photodamage. J Clin Aesthet Dermatol. 2015 Oct;8(10):21-6.
PubMed 26557215
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tolerability and Efficacy of a Three Product Anti-Aging Treatment Regimen in Subjects With Moderate to Severe Photodamage
- ClinicalTrials.gov ID
- NCT02422836
- Acronym / sponsor ID
- USC-06-13.1
- Conditions
- Skin Manifestations
- Keywords
- photodamage, fine lines, wrinkles, dyschromia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- US CosmeceuTechs, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Apr 2015 (estimated)
- 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 subjects will use the test skincare products. This is a full face, twice daily application study, with digital photos and expert grader evaluations at Baseline, 4 and 8 week periods. If the subject meets the study criteria and is enrolled, they will be instructed at screening visit to discontinue the use of any facial products (except dry mineral foundation and eye make-up) for seven (7) days before beginning the study (referred to as the "washout" period). They will return to the site for the baseline visit 2 after the required 7 day washout period (visit can occur within 1 week after screening visit).
Detailed description
After the subjects properly consent to participation and are determined eligible, the study coordinator will review the subjects' medical history and obtain demographics. The Principal Investigator (PI) or designee (expert grader) will examine the subjects to determine their appropriateness for study inclusion.
At the Screening visit (Visit 1, Day -10 to -7), the subjects will be assessed by the PI or designee to confirm inclusion into the study. Expert grading and Canfield VISIA CR photographic documentation (all flash modes including RBX) will be performed at baseline (Visit 2, Day 0), Week 4 (Visit 3, Day 28 ± 7 days), and Week 8 (Visit 4, Day 56 ± 7 days).
Subjects who, in the PI's or designee's opinion, appear to be experiencing product related adverse reactions may be discontinued at any time during the study. The subjects' home care treatment products (the items included in the kit) will be performed at home, at the times and in the manner described in the instructions provided.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three Product Anti-Aging Regimen | Experimental | Other: Three Product Anti-Aging Treatment RegimenThree Product Anti-Aging Treatment Regimen: Cream Skin Cleanser RD04033B, twice daily, 8 weeks; Anti-aging Cream RD04034B, twice daily, 8 weeks; and Sunscreen SPF 50 RD04036, once daily, reapply as needed, 8 weeks |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be diagnosed by the investigator or expert grader to have moderate to severe lines/wrinkles (Grade 3 or higher, determined by the Glogau Scale).
- Subjects must be 35 - 65 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Sexually active females of childbearing potential participating in the study must agree to use a medically-acceptable method of contraception while receiving study product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Exception: Sexually inactive females of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the investigator's discretion, provided that they understand the possible risks involved in getting pregnant during the study and are counseled to remain sexually inactive for the duration of the study or to practice a reliable method of contraception if becoming sexually active during the study.
- Subjects must sign a written informed consent.
Key exclusion criteria (11 listed)
- Any dermatologic disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's facial skin. Examples of such disorders include severe acne vulgaris, acne conglobata, acne fulminans, facial seborrheic dermatitis, and lupus erythematosus.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Concurrent therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.
- Subjects who are not willing to discontinue their normal facial cosmetics during the study period. The subjects' dry mineral foundation and eye make-up are permitted, no liquid foundation; no other facial products other than the provided skincare products may be used.
- Subjects who have used anti-aging skincare products (cosmetic and drug products with any of the following ingredients: AHA, Salicylic Acid, Vitamins A, Retin-A, Vitamin C, Growth Factors or Peptides, Antioxidants such as Idebenone, CoffeeBerry, CE Ferulic, Phloretin, etc.) within the last 3 months and during the course 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 |
|---|---|---|
| Three Product Anti-Aging Treatment RegimenAlso: Anti-aging Cream, Sunscreen SPF 50, Cream Skin CleanserCream Skin Cleanser RD04033B, twice daily, 8 weeks; Anti-aging Cream RD04034B, twice daily, 8 weeks; and Sunscreen SPF 50 RD04036, once daily, reapply as needed, 8 weeks | Other | Three Product Anti-Aging Regimen |
Primary outcome
Glogau Photodamage Scale: the change between the photodamage grade at Week 4 and Week 8 compared to the photodamage grade at the Baseline Visit.
Time frame: 8 weeks
The Glogau Photodamage Scale (Type I: No wrinkles, Type II: Wrinkles in motion, Type III: Wrinkles at rest, Type IV: Only wrinkles) represents a qualitative assessment to measure the severity of photodamage and wrinkles. Photodamage was graded at the Screening Visit (Day -10 to Day -7), Baseline Visit (Day 0), Week 4 Visit (Day 28), and Week 8 Visit (Day 56). The endpoint that was used to evaluate the primary objective of the study is the delta (change) between the photodamage grade at Week 4 Visit (Day 28) and Week 8 Visit (Day 56) compared to the photodamage grade at the Baseline Visit.
3 secondary outcomes
Dryness and Flaking: the change between the dryness grade at Week 4 and Week 8 compared to the dryness grade at the Baseline Visit.
Time frame: 8 weeks
Dyschromia: the change between the dyschromia grade at Week 4 and Week 8 compared to the dyschromia grade at the Baseline Visit.
Time frame: 8 weeks
Stinging and Burning: the change between the stinging grade at Week 4 and Week 8 compared to the stinging grade at the Baseline Visit.
Time frame: 8 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 21 Apr 2015.
- Derived from this study: PubMed 26557215Katz BE, Lewis J, McHugh L, Pellegrino A, Popescu L. The Tolerability and Efficacy of a Three-product Anti-aging Treatment Regimen in Subjects with Moderate-to-severe Photodamage. J Clin Aesthet Dermatol. 2015 Oct;8(10):21-6.
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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.
Bruce Katz, MD principal investigator
JUVA Skin & Laser Center / MediSpa
Questions about this trial
What is this clinical trial studying?
A study testing Three Product Anti-Aging Treatment Regimen in people with Skin Manifestations, run by US CosmeceuTechs, LLC.
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 11 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Glogau Photodamage Scale: the change between the photodamage grade at Week 4 and Week 8 compared to the photodamage grade at the Baseline Visit. (time frame: 8 weeks). 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 NCT02422836, 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 21 Apr 2015.