Skin AgingNCT03180645
Proof of Concept Anti-ageing Clinical Study in Healthy Subjects
A study testing Test product (Moisturising cream) and No treatment in people with Skin Aging, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
The objective of this POC clinical study is to evaluate the moisturising effects on fine lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks of twice daily application of the test product on participants presenting visible signs of ageing. 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
- Skin Aging
- What is being tested?
- Test product (Moisturising cream) and No treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 20 Mar 2017to 21 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant and relevant abnormalities in medical history or upon physical examination
- Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that participant
- Willingness to actively participate in the study and to attend all scheduled visits
- Fitzpatrick phototype I-IV
- Visual Clinical Fitzpatrick Wrinkle Score 3- 6 in the eye (crow's feet) area on both sides of the face at screening and baseline
- Subjects with self-reported sensitive skin
Who cannot join
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g.diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluations
- Change in contraception within the last 3 months
- Presence of open sores, pimples, cysts, irritated skin, hairs or tattoos at the application site
- Active dermatosis (local or disseminated) that might interfere with the results of the study
Show all 25Show fewer
- Considered immune compromised
- Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk
- Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit
- Intention of using any oral or topical steroids
- Regular use of inhaled steroids (occasional use is permitted)
- Regular use of topical anti-itch medications (occasional use permitted; the product should be applied with an applicator but not to the proposed application areas
- Use of any topical drug or medication in the proposed application areas
- Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit
- Currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation
- Blepharitis, conjunctivitis, uveitis
- Topical ocular treatment within the last month
- Aesthetic, cosmetic or dermatological treatment on the face within the last 3 months
- Intense sun exposure, Ultra Violet-treatments or tanning salon visit within the last 2 weeks
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit
- Previous participation in this study
- Recent history (within the last 5 years) of alcohol or other substance abuse
- An employee of the sponsor or the study site or members of their immediate family
- A smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Concept (POC) Clinical Study to Evaluate the Appearance of Fine Lines and Wrinkles on a Developmental Cosmetic Moisturising Cream in Healthy Subjects Presenting Visible Signs of Ageing
The objective of this POC clinical study is to evaluate the moisturising effects on fine lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks of twice daily application of the test product on participants presenting visible signs of ageing.
Read the detailed description
Participants who meet all the inclusion/exclusion criteria will be randomised to one of three treatment groups: test product/positive control, test product/no treatment or positive control/no treatment at the baseline visit. Product application within treatment group will be further randomised to either the right or left side of the face. Participants will apply one of the assigned treatments to one side of the face (left or right) and another assigned treatment to the other side of the face as per the randomisation schedule. Participants will be instructed to apply the assigned treatments twice daily (morning and evening, approximately 8-12 hours apart) for 4 weeks (28 days).
- Conditions
- Skin Aging
- Being tested
- Test product (Moisturising cream), Positive control (Commercial market place moisturising cream), No treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product (Moisturising cream)Other
Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening).
Positive control (Commercial market place moisturising cream)Other
Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening).
No treatmentOther
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Test product/ No treatment | Other | Participants randomized to this arm will apply Test product at allocated sites and leave other sites untreated. Receives: Other: Test product (Moisturising cream); Other: No treatment |
| Test product/ Positive control | Other | Participants randomized to this arm will apply Test and positive product at allocated sites. Receives: Other: Test product (Moisturising cream); Other: Positive control (Commercial market place moisturising cream) |
| Positive control /No treatment | Other | Participants randomized to this arm will apply Positive product at allocated sites and leave other sites untreated. Receives: Other: Positive control (Commercial market place moisturising cream); Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29
Using fringe projection and optical triangulation techniques, the 3D (three dimensional) surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).
Measured: At Baseline and Day 29
Secondary outcomes (11)
Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15
Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).
Measured: At Baseline and Day 15
Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29
Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra is the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).
Measured: At Baseline, Day 15 and 29
Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29
Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Rz usually used for wrinkle assessments, representing the rough structure, such as wrinkles. Rz was an average of the 5 sub-profiles (peak to valley heights) local maximum. From each local profile the peak to peak height value is calculated; the average of the 5 peak to peak height values was Rz.
Measured: At Baseline, Day 15 and 29
Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29
Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. The 3D skin surface profile was calculated from the position of the fringes in combination with the Gray values of each pixel. From the captured 3D structure, roughness parameters were calculated. Sa was the arithmetic average of the absolute (non- signed) heights of the topography points. Sa was the 3D Area -Equivalent of 2D profile roughness parameter Ra.
Measured: At Baseline, Day 15 and 29
Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29
Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. The 3D skin surface profile was calculated from the position of the fringes in combination with the Gray values of each pixel. From the captured 3D structure, roughness parameters were calculated. Stm was an average of the 5x5 sub-areas (peak to valley heights) local maximum: The surface was virtually divided into 25 sub-surfaces (5 rows, 5 columns); from each local surface the peak to peak height value is calculated; the average of the 25 peak to height values was Stm.
Measured: At Baseline, Day 15 and 29
Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29
A blinded, trained and qualified examiner performed Clinical Fitzpatrick Wrinkle Score assessments by visually grading the crow's feet area under standard conditions of illumination. Fitzpatrick Wrinkle Scores range between 1-9 where 1-3= Fine wrinkles, 4-6= Fine to moderate depth wrinkles, a moderate number of wrinkles, 7-9= Fine to deep wrinkles, numerous lines, with or without redundant skin folds. Low value indicated better results.
Measured: At Baseline, Day 15 and 29
Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29
Measurement of Stratum Corneum (SC) hydration was performed by the electrical capacitance method with a Corneometer. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. An electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturisation was measured. Higher value of corneometery indicates high moisture content.
Measured: At Baseline, Day 15 and 29
Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29
High resolution images of the left and right side of each participant's whole half-face were taken at baseline and Day 29. Each blinded image pair was randomly displayed on a color-calibrated screen and assessed by a panel of lay graders, who ranked each image based on texture, defined as pores, smoothness and unevenness, on a scale of: 1 = better; or 2 = worse (lower score indicated improvement). The total proportion of improvement (from all lay graders) on Day 29 than baseline is reported for this endpoint.
Measured: At Baseline and Day 29
Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29
The Cutometer measures elasticity of the upper skin layer using negative pressure which deforms the skin mechanically. Negative pressure was created in the device and the skin was drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth was determined by a non-contact optical measuring system. The light intensity varies due to the penetration depth of the skin. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) was displayed as curves (penetration depth in mm/time) in real time during the measurement. This measurement principle provides information about the elastic and mechanical properties of the skin surface and enables objective quantification of skin ageing. R5 (net elasticity): the elastic portion of the suction part versus the elastic portion of the relaxation part.
Measured: At Baseline, Day 15 and 29
Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29
The Cutometer measures elasticity of the upper skin layer using negative pressure which deforms the skin mechanically. Negative pressure was created in the device and the skin was drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth was determined by a non-contact optical measuring system. The light intensity varies due to the penetration depth of the skin. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in mm/time) in real time during the measurement. This measurement principle provides information about the elastic and mechanical properties of the skin surface and enables objective quantification of skin ageing. R7: Portion of the elasticity compared to the complete curve values.
Measured: At Baseline, Day 15 and 29
Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29
TEWL measuring principle was based on water vapour gradient determination between two pairs of sensors (temperature and relative humidity) placed at different distances perpendicularly to the skin. Measurements were taken in triplicate and then an average (mean) reading was calculated on the left and right Sub-ocular/ Cheek Area directly from the corner of the eyes onto the middle of the cheekbone. A decrease in TEWL corresponds to an improved skin barrier function.
Measured: At Baseline, Day 15 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start20 Mar 2017
- Primary completion21 Apr 2017
- Study completion21 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180645
- Sponsor's protocol ID
- 207468
- Status last verified
- Mar 2019
- First submitted
- 6 Jun 2017
- Last updated
- 1 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nisbet S, Mahalingam H, Gfeller CF, Biggs E, Lucas S, Thompson M, Cargill MR, Moore D, Bielfeldt S. Cosmetic benefit of a biomimetic lamellar cream formulation on barrier function or the appearance of fine lines and wrinkles in randomized proof-of-concept clinical studies. Int J Cosmet Sci. 2019 Feb;41(1):1-11. doi: 10.1111/ics.12499. Epub 2019 Feb 22.
PubMed 30414275
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept (POC) Clinical Study to Evaluate the Appearance of Fine Lines and Wrinkles on a Developmental Cosmetic Moisturising Cream in Healthy Subjects Presenting Visible Signs of Ageing
- ClinicalTrials.gov ID
- NCT03180645
- Acronym / sponsor ID
- 207468
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 8 Jun 2017 (actual)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this POC clinical study is to evaluate the moisturising effects on fine lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks of twice daily application of the test product on participants presenting visible signs of ageing.
Detailed description
Participants who meet all the inclusion/exclusion criteria will be randomised to one of three treatment groups: test product/positive control, test product/no treatment or positive control/no treatment at the baseline visit. Product application within treatment group will be further randomised to either the right or left side of the face. Participants will apply one of the assigned treatments to one side of the face (left or right) and another assigned treatment to the other side of the face as per the randomisation schedule. Participants will be instructed to apply the assigned treatments twice daily (morning and evening, approximately 8-12 hours apart) for 4 weeks (28 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product/ No treatment | Other | Other: Test product (Moisturising cream), Other: No treatmentParticipants randomized to this arm will apply Test product at allocated sites and leave other sites untreated. |
| Test product/ Positive control | Other | Other: Test product (Moisturising cream), Other: Positive control (Commercial market place moisturising cream)Participants randomized to this arm will apply Test and positive product at allocated sites. |
| Positive control /No treatment | Other | Other: Positive control (Commercial market place moisturising cream), Other: No treatmentParticipants randomized to this arm will apply Positive product at allocated sites and leave other sites untreated. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant and relevant abnormalities in medical history or upon physical examination
- Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that participant
- Willingness to actively participate in the study and to attend all scheduled visits
- Fitzpatrick phototype I-IV
Key exclusion criteria (25 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g.diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluations
- Change in contraception within the last 3 months
- Presence of open sores, pimples, cysts, irritated skin, hairs or tattoos at the application site
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 |
|---|---|---|
| Test product (Moisturising cream)Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening). | Other | Test product/ No treatment, Test product/ Positive control |
| Positive control (Commercial market place moisturising cream)Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening). | Other | Positive control /No treatment, Test product/ Positive control |
| No treatmentNo treatment | Other | Positive control /No treatment, Test product/ No treatment |
Primary outcome
Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29
Time frame: At Baseline and Day 29
Using fringe projection and optical triangulation techniques, the 3D (three dimensional) surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).
11 secondary outcomes
Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15
Time frame: At Baseline and Day 15
Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29
Time frame: At Baseline, Day 15 and 29
Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29
Time frame: At Baseline, Day 15 and 29
Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29
Time frame: At Baseline, Day 15 and 29
Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29
Time frame: At Baseline, Day 15 and 29
Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29
Time frame: At Baseline, Day 15 and 29
Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29
Time frame: At Baseline, Day 15 and 29
Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29
Time frame: At Baseline and Day 29
Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29
Time frame: At Baseline, Day 15 and 29
Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29
Time frame: At Baseline, Day 15 and 29
Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29
Time frame: At Baseline, Day 15 and 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30414275Nisbet S, Mahalingam H, Gfeller CF, Biggs E, Lucas S, Thompson M, Cargill MR, Moore D, Bielfeldt S. Cosmetic benefit of a biomimetic lamellar cream formulation on barrier function or the appearance of fine lines and wrinkles in randomized proof-of-concept clinical studies. Int J Cosmet Sci. 2019 Feb;41(1):1-11. doi: 10.1111/ics.12499. Epub 2019 Feb 22.
- Individual participant dataSharing planned: No
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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.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product (Moisturising cream) and No treatment in people with Skin Aging, run by GlaxoSmithKline at 1 site in Germany.
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 7 inclusion and 25 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 1 Jul 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 Germany. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29 (time frame: At Baseline and Day 29). 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 NCT03180645, 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 1 Jul 2019.