Photodamaged SkinNCT04065035
A Clinical Study to Evaluate Efficacy and Tolerability of a Cosmetic Product for Arm Firming
A study testing Topical Body Firming Moisturizer, Body Cleanser and Sunscreen in people with Photodamaged Skin and Skin Care, run by Revision Skincare at 1 site in United States.
Trial summary
This single-center, split-body, double-blind, randomized, controlled clinical trial was conducted to assess the efficacy and tolerance of a topical firming body moisturizer when used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and overall photodamage on the upper arms. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photodamaged Skin, Skin Care
- What is being tested?
- Topical Body Firming Moisturizer, Body Cleanser and Sunscreen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2018to 17 Jul 2019
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range between 40 and 60 years
- Mild to moderate skin crepiness upper arm region
- Mild to moderate sagging skin upper arm region
- Mild to moderate overall photodamage upper arm region
- Willing to maintain their body weight within +/- 6.5 pounds
Who cannot join
- Diagnosed with known allergies to skin care products
- Who have had massive weight loss
- Who have undergone liposuction and/or weight loss surgery in the last 5 years.
- Who are nursing
- Who are pregnant
- History of skin cancer within the past 5 years.
Show all 18Show fewer
- Having a health condition
- Having a history of immunosuppression/immune deficiency disorders
- Currently using oral or systemic immunosuppressive medications and biologics
- Currently using or having regularly used corticosteroids
- Having a disease such as asthma
- Having started a long-term medication within the last 2 months.
- Who started hormone replacement therapies (HRT)
- Having had brachioplasty (upper arm lift);
- Having liposuction
- Having cryolipolysis
- Having undergone a weight-loss diet or exercise habit change in the last 3 months or planning to start either during the study.
- Having used any of the indicated products or had any of the listed procedures on the upper arms within the indicated time frame prior to the study start date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind Split-Body Placebo-Controlled Clinical Study to Evaluate the Efficacy of a Cosmetic Product for Arm Firming
This single-center, split-body, double-blind, randomized, controlled clinical trial was conducted to assess the efficacy and tolerance of a topical firming body moisturizer when used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and overall photodamage on the upper arms. A total of 40 subjects completed study participation which included 10 subjects in the biopsy subgroup.
Read the detailed description
This single-center, split-body, double-blind, randomized, controlled clinical trial is being conducted to assess the efficacy and tolerance of the topical firming body moisturizer when used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and overall photodamage on the upper arms.
Efficacy and tolerance will be assessed through clinical grading at baseline and weeks 4, 8, and 12. Efficacy will also be assessed through Corneometer and upper arm circumference measurements at baseline and weeks 4, 8, and 12, and Cutometer and Ultrasound measurements at baseline and weeks 8 and 12. Self-assessment questionnaires will be completed at baseline and week 12. Digital images will be taken at baseline and weeks 4, 8, and 12. Vectra H2 3D images will be taken at baseline and weeks 8 and 12. BMI will be measured at baseline and weeks 8 and 12. Biopsies will be collected from a subgroup of at least 10 subjects at baseline and week 12 (two biopsies on each arm at each time point; total of 8 per biopsy subject).
A total of 40 subjects completed study participation which included 10 subjects in the biopsy subgroup.
- Conditions
- Photodamaged Skin, Skin Care
- Being tested
- Topical Body Firming Moisturizer, Body Cleanser, Sunscreen, Placebo Moisturizer
- Keywords
- Body, moisturizer, Firming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Body Firming MoisturizerOther
Moisturizer composed of a patent-pending blend of botanical extracts, bioavailable peptides, antioxidants, and a prebiotic innovation
Body CleanserOther
Also called Dove Sensitive Skin Nourishing Body Wash
Body cleanser to be used by study participants
SunscreenOther
Also called Neutrogena® Ultra Sheer® Dry-Touch Sunscreen Broad Spectrum Sunscreen Protection Factor 55
Sunscreen to be applied after application of moisturizer
Placebo MoisturizerOther
Placebo moisturizer is the vehicle control of the topical body firming moisturizer
| Study group | Role | What they receive |
|---|---|---|
| Topical Firming Body Moisturizer | Active comparator | Oil-in-water emulsion base containing emollients, botanical extracts, peptides, antioxidants, prebiotics, and modified theophylline ingredients. Receives: Other: Topical Body Firming Moisturizer; Other: Body Cleanser; Other: Sunscreen |
| Placebo Moisturizer | Placebo comparator | Oil-in-water emulsion base containing emollients. Receives: Other: Body Cleanser; Other: Sunscreen; Other: Placebo Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Skin Crepiness Score
Investigator assessed the participants' skin crepiness using a 10-point scale where none 0 = skin appears smooth with no crinkling to severe 9 = prominent, extensive crinkly texture at baseline, week 4, 8, and 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Skin Elasticity Score
Investigator assessed the participants' skin elasticity using a 10-point scale where none 0 = skin feels toned, dense and resilient to severe 9 = skin feels pliable, thin and nonresilient at baseline, week 8 and 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Skin Firmness Score
Investigator assessed the participants' skin firmness using a 10-point scale where none 0 = skin appears very firm and feels thick to severe 9 = loose-appearing skin with poor stretch properties at baseline, week 8 and 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Skin Sagging Score
Investigator assessed the participants' skin sagging using a 10-point scale where none 0 = no sagging, upper arm shows tight, lifted appearance to severe 9 = upper arm shows extreme sagging appearance at baseline, week 8 and 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Skin Roughness (Visual) Score
Investigator assessed the participants' skin roughness (visual) using a 10-point scale where none 0 = smooth skin appearance, no roughness to severe 9 = pronounced reduction in skin smoothness appearance at baseline, week 4. 8, and 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Skin Roughness (Tactile) Score
Investigator assessed the participants' skin roughness (tactile) using a 10-point scale where none 0 = no palpable skin roughness, drag or surface bumps to severe 9 = significantly palpable skin roughness, drag, and surface bumps at baseline, week 4, 8 and 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Overall Photodamage Score
Investigator assessed the participants' overall photodamage using a 10-point scale where none 0 = none or minimal visual evidence of photodamaged skin to severe 9 = severe photodamaged skin at baseline, week 8 and 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Evenness of Skin Tone Score
Investigator assessed the participants' evenness of skin tone using a 10-point scale where none 0 = even skin color, no observable hyperpigmentation to severe 9 = significant detectable hyperpigmentation appearance at baseline, week 8 and 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Evenness of Skin Redness Score
Investigator assessed the participants' evenness of skin redness using a 10-point scale where none 0 = even skin tone to severe 9 = pronounced areas of redness at baseline, week 4, 8, and 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Objective Erythema Parameters
Investigator assessed the participants' signs of erythema using a 4-point scale where none 0 = no erythema to severe 4 = marked redness at baseline and week 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Objective Edema Parameters
Investigator assessed the participants' signs of edema using a 4-point scale where none 0 = no edema or swelling to severe 4 = marked edema at baseline and week 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Objective Dryness Parameters
Investigator assessed the participants' signs of dryness using a 4-point scale where none 0 = no dryness to severe 4 = marked dryness at baseline and week 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Objective Peeling Parameters
Investigator assessed the participants' signs of peeling using a 4-point scale where none 0 = no peeling to severe 4 = marked peeling at baseline and week 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Subjective Burning Parameters
Participants assessed signs of burning using a 4-point scale where none 0 = no burning to severe 4 = hot burning sensation at baseline and week 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Subjective Stinging Parameters
Participants assessed signs of stinging using a 4-point scale where none 0 = no stinging to severe 4 = marked stinging sensation at baseline and week 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Subjective Itching Parameters
Participants assessed signs of itching using a 4-point scale where none 0 = no itching to severe 4 = marked itching sensation at baseline and week 12. A decrease in score indicates improvement.
Measured: 12 weeks
Change from Baseline in Subjective Tingling Parameters
Participants assessed signs of tingling using a 4-point scale where none 0 = no tingling to severe 4 = marked tingling sensation at baseline and week 12. A decrease in score indicates 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 posted22 Aug 2019
- Study start13 Dec 2018
- Primary completion1 Apr 2019
- Study completion17 Jul 2019
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
- Parallel groups
- Model description
- Split Body, randomized, and placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stephens & Associates, Inc.
- Responsible party
- Sponsor
- Investigators
- Lily Jiang, PhD, Principal investigator, Thomas J. Stephens & Associates, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065035
- Sponsor's protocol ID
- C18-D134
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Split-Body Placebo-Controlled Clinical Study to Evaluate the Efficacy of a Cosmetic Product for Arm Firming
- ClinicalTrials.gov ID
- NCT04065035
- Acronym / sponsor ID
- C18-D134
- Conditions
- Photodamaged Skin, Skin Care
- Keywords
- Body, moisturizer, Firming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Collaborators
- Stephens & Associates, Inc.
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 22 Aug 2019 (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 single-center, split-body, double-blind, randomized, controlled clinical trial was conducted to assess the efficacy and tolerance of a topical firming body moisturizer when used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and overall photodamage on the upper arms. A total of 40 subjects completed study participation which included 10 subjects in the biopsy subgroup.
Detailed description
This single-center, split-body, double-blind, randomized, controlled clinical trial is being conducted to assess the efficacy and tolerance of the topical firming body moisturizer when used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and overall photodamage on the upper arms.
Efficacy and tolerance will be assessed through clinical grading at baseline and weeks 4, 8, and 12. Efficacy will also be assessed through Corneometer and upper arm circumference measurements at baseline and weeks 4, 8, and 12, and Cutometer and Ultrasound measurements at baseline and weeks 8 and 12. Self-assessment questionnaires will be completed at baseline and week 12. Digital images will be taken at baseline and weeks 4, 8, and 12. Vectra H2 3D images will be taken at baseline and weeks 8 and 12. BMI will be measured at baseline and weeks 8 and 12. Biopsies will be collected from a subgroup of at least 10 subjects at baseline and week 12 (two biopsies on each arm at each time point; total of 8 per biopsy subject).
A total of 40 subjects completed study participation which included 10 subjects in the biopsy subgroup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Split Body, randomized, and placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Topical Firming Body Moisturizer | Active comparator | Other: Topical Body Firming Moisturizer, Other: Body Cleanser, Other: SunscreenOil-in-water emulsion base containing emollients, botanical extracts, peptides, antioxidants, prebiotics, and modified theophylline ingredients. |
| Placebo Moisturizer | Placebo comparator | Other: Body Cleanser, Other: Sunscreen, Other: Placebo MoisturizerOil-in-water emulsion base containing emollients. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range between 40 and 60 years
- Mild to moderate skin crepiness upper arm region
- Mild to moderate sagging skin upper arm region
- Mild to moderate overall photodamage upper arm region
- Willing to maintain their body weight within +/- 6.5 pounds
Key exclusion criteria (18 listed)
- Diagnosed with known allergies to skin care products
- Who have had massive weight loss
- Who have undergone liposuction and/or weight loss surgery in the last 5 years.
- Who are nursing
- Who are 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 |
|---|---|---|
| Topical Body Firming MoisturizerMoisturizer composed of a patent-pending blend of botanical extracts, bioavailable peptides, antioxidants, and a prebiotic innovation | Other | Topical Firming Body Moisturizer |
| Body CleanserAlso: Dove Sensitive Skin Nourishing Body WashBody cleanser to be used by study participants | Other | Placebo Moisturizer, Topical Firming Body Moisturizer |
| SunscreenAlso: Neutrogena® Ultra Sheer® Dry-Touch Sunscreen Broad Spectrum Sunscreen Protection Factor 55Sunscreen to be applied after application of moisturizer | Other | Placebo Moisturizer, Topical Firming Body Moisturizer |
| Placebo MoisturizerPlacebo moisturizer is the vehicle control of the topical body firming moisturizer | Other | Placebo Moisturizer |
Primary outcome
Change from Baseline in Skin Crepiness Score
Time frame: 12 weeks
Investigator assessed the participants' skin crepiness using a 10-point scale where none 0 = skin appears smooth with no crinkling to severe 9 = prominent, extensive crinkly texture at baseline, week 4, 8, and 12. A decrease in score indicates improvement.
Change from Baseline in Skin Elasticity Score
Time frame: 12 weeks
Investigator assessed the participants' skin elasticity using a 10-point scale where none 0 = skin feels toned, dense and resilient to severe 9 = skin feels pliable, thin and nonresilient at baseline, week 8 and 12. A decrease in score indicates improvement.
Change from Baseline in Skin Firmness Score
Time frame: 12 weeks
Investigator assessed the participants' skin firmness using a 10-point scale where none 0 = skin appears very firm and feels thick to severe 9 = loose-appearing skin with poor stretch properties at baseline, week 8 and 12. A decrease in score indicates improvement.
Change from Baseline in Skin Sagging Score
Time frame: 12 weeks
Investigator assessed the participants' skin sagging using a 10-point scale where none 0 = no sagging, upper arm shows tight, lifted appearance to severe 9 = upper arm shows extreme sagging appearance at baseline, week 8 and 12. A decrease in score indicates improvement.
Change from Baseline in Skin Roughness (Visual) Score
Time frame: 12 weeks
Investigator assessed the participants' skin roughness (visual) using a 10-point scale where none 0 = smooth skin appearance, no roughness to severe 9 = pronounced reduction in skin smoothness appearance at baseline, week 4. 8, and 12. A decrease in score indicates improvement.
Change from Baseline in Skin Roughness (Tactile) Score
Time frame: 12 weeks
Investigator assessed the participants' skin roughness (tactile) using a 10-point scale where none 0 = no palpable skin roughness, drag or surface bumps to severe 9 = significantly palpable skin roughness, drag, and surface bumps at baseline, week 4, 8 and 12. A decrease in score indicates improvement.
Change from Baseline in Overall Photodamage Score
Time frame: 12 weeks
Investigator assessed the participants' overall photodamage using a 10-point scale where none 0 = none or minimal visual evidence of photodamaged skin to severe 9 = severe photodamaged skin at baseline, week 8 and 12. A decrease in score indicates improvement.
Change from Baseline in Evenness of Skin Tone Score
Time frame: 12 weeks
Investigator assessed the participants' evenness of skin tone using a 10-point scale where none 0 = even skin color, no observable hyperpigmentation to severe 9 = significant detectable hyperpigmentation appearance at baseline, week 8 and 12. A decrease in score indicates improvement.
Change from Baseline in Evenness of Skin Redness Score
Time frame: 12 weeks
Investigator assessed the participants' evenness of skin redness using a 10-point scale where none 0 = even skin tone to severe 9 = pronounced areas of redness at baseline, week 4, 8, and 12. A decrease in score indicates improvement.
Change from Baseline in Objective Erythema Parameters
Time frame: 12 weeks
Investigator assessed the participants' signs of erythema using a 4-point scale where none 0 = no erythema to severe 4 = marked redness at baseline and week 12. A decrease in score indicates improvement.
Change from Baseline in Objective Edema Parameters
Time frame: 12 weeks
Investigator assessed the participants' signs of edema using a 4-point scale where none 0 = no edema or swelling to severe 4 = marked edema at baseline and week 12. A decrease in score indicates improvement.
Change from Baseline in Objective Dryness Parameters
Time frame: 12 weeks
Investigator assessed the participants' signs of dryness using a 4-point scale where none 0 = no dryness to severe 4 = marked dryness at baseline and week 12. A decrease in score indicates improvement.
Change from Baseline in Objective Peeling Parameters
Time frame: 12 weeks
Investigator assessed the participants' signs of peeling using a 4-point scale where none 0 = no peeling to severe 4 = marked peeling at baseline and week 12. A decrease in score indicates improvement.
Change from Baseline in Subjective Burning Parameters
Time frame: 12 weeks
Participants assessed signs of burning using a 4-point scale where none 0 = no burning to severe 4 = hot burning sensation at baseline and week 12. A decrease in score indicates improvement.
Change from Baseline in Subjective Stinging Parameters
Time frame: 12 weeks
Participants assessed signs of stinging using a 4-point scale where none 0 = no stinging to severe 4 = marked stinging sensation at baseline and week 12. A decrease in score indicates improvement.
Change from Baseline in Subjective Itching Parameters
Time frame: 12 weeks
Participants assessed signs of itching using a 4-point scale where none 0 = no itching to severe 4 = marked itching sensation at baseline and week 12. A decrease in score indicates improvement.
Change from Baseline in Subjective Tingling Parameters
Time frame: 12 weeks
Participants assessed signs of tingling using a 4-point scale where none 0 = no tingling to severe 4 = marked tingling sensation at baseline and week 12. A decrease in score indicates improvement.
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 22 Aug 2019.
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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.
Lily Jiang, PhD principal investigator
Thomas J. Stephens & Associates, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Body Firming Moisturizer, Body Cleanser and Sunscreen in people with Photodamaged Skin and Skin Care, 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 18 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 22 Aug 2019. 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. Some participants in this study may receive a placebo. 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 from Baseline in Skin Crepiness Score (time frame: 12 weeks). The study lists 17 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 22 Aug 2019.