ErythemaNCT05300542
Efficacy Study of a Novel Skin Health Product to Reduce an UVB Induced Erythema
A study testing Topical Cream with 0.5% Active and Topical Cream with 1% Active in people with Erythema and Sun Damaged Skin, run by Amazentis SA at 1 site in Germany.
Trial summary
The aim of this study is to determine the erythema-reducing efficacy of a test product in two concentrations on a light sunburn induced by a sun simulator compared to an untreated control and a placebo product. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Erythema, Sun Damaged Skin, Skin Inflammation
- What is being tested?
- Topical Cream with 0.5% Active and Topical Cream with 1% Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 17 Mar 2022to 13 Apr 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written Informed Consent to participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits
- Female and/or male
- From 18 to 65 years of age
- Uniform skin color and no erythema or dark pigmentation in the test area
- ITA° > 28 in the test area
Who cannot join
- Female subjects: Pregnancy or lactation
- Drug addicts, alcoholics
- AIDS, HIV-positive or infectious hepatitis
- Conditions which exclude a participation or might influence the test reaction/evaluation
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
- One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
Show all 20Show fewer
- Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
- Insulin-dependent diabetes mellitus
- Electronic implant (e.g. pace maker, insulin pump, hearing aid, and the like) that cannot be removed during irradiation
- Documented allergies to cosmetic products and/or ingredients
- Active skin disease at the test area
- Irregularly tanned skin in the test area
- Medical history of dysplastic nevi, melanoma or other skin carcinoma
- Medical history of abnormal response to sunlight
- Regular use of tanning beds (more than 10 times within the last 6 months)
- Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- Usage of medication with known photo-toxic and/or photo-sensitizing potential (e.g. some antibiotics, blood pressure regulating agents and antidepressants agents; hypericum perforatum) within the last 14 days prior to the start of the study and/or throughout the entire course of the study
- Any topical medication at the test area within the last 7 days prior to the start of the study and/or throughout the entire course of the study
- Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study and/or throughout the entire course of the study
- Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study and/or throughout the entire course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Study of a Novel Cosmetic Product to Reduce an UVB Induced Erythema
The aim of this study is to determine the erythema-reducing efficacy of a test product in two concentrations on a light sunburn induced by a sun simulator compared to an untreated control and a placebo product.
- Conditions
- Erythema, Sun Damaged Skin, Skin Inflammation
- Being tested
- Topical Placebo Cream, Topical Cream with 0.5% Active, Topical Cream with 1% Active
- Medical subject headings
- Erythema, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Placebo CreamOther
Application of test products before and after irradiation
Topical Cream with 0.5% ActiveOther
Application of test products before and after irradiation
Topical Cream with 1% ActiveOther
Application of test products before and after irradiation
| Study group | Role | What they receive |
|---|---|---|
| Skin UVB irradiated 1.25MED | Experimental | Not described Receives: Other: Topical Placebo Cream; Other: Topical Cream with 0.5% Active; Other: Topical Cream with 1% Active |
| Skin UVB irradiated 1.6MED | Experimental | Not described Receives: Other: Topical Placebo Cream; Other: Topical Cream with 0.5% Active; Other: Topical Cream with 1% Active |
| Untreated Skin | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema (skin redness) assessed by Chromameter
Measured: 3 days
Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start17 Mar 2022
- Primary completion31 Mar 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD, Study chair, proDERM GmbHDr. rer. nat. Sabrina Laing, MD, Principal investigator, proDERM GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300542
- Sponsor's protocol ID
- 22.02.AMZ
- Other IDs
- 22.0103-65
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of a Novel Cosmetic Product to Reduce an UVB Induced Erythema
- ClinicalTrials.gov ID
- NCT05300542
- Acronym / sponsor ID
- 22.02.AMZ
- Conditions
- Erythema, Sun Damaged Skin, Skin Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the erythema-reducing efficacy of a test product in two concentrations on a light sunburn induced by a sun simulator compared to an untreated control and a placebo product.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Skin UVB irradiated 1.25MED | Experimental | Other: Topical Placebo Cream, Other: Topical Cream with 0.5% Active, Other: Topical Cream with 1% Active |
| Skin UVB irradiated 1.6MED | Experimental | Other: Topical Placebo Cream, Other: Topical Cream with 0.5% Active, Other: Topical Cream with 1% Active |
| Untreated Skin | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written Informed Consent to participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits
- Female and/or male
- From 18 to 65 years of age
- Uniform skin color and no erythema or dark pigmentation in the test area
Key exclusion criteria (20 listed)
- Female subjects: Pregnancy or lactation
- Drug addicts, alcoholics
- AIDS, HIV-positive or infectious hepatitis
- Conditions which exclude a participation or might influence the test reaction/evaluation
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
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 Placebo CreamApplication of test products before and after irradiation | Other | Skin UVB irradiated 1.25MED, Skin UVB irradiated 1.6MED |
| Topical Cream with 0.5% ActiveApplication of test products before and after irradiation | Other | Skin UVB irradiated 1.25MED, Skin UVB irradiated 1.6MED |
| Topical Cream with 1% ActiveApplication of test products before and after irradiation | Other | Skin UVB irradiated 1.25MED, Skin UVB irradiated 1.6MED |
Primary outcome
Erythema (skin redness) assessed by Chromameter
Time frame: 3 days
Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness)
Time frame: 3 days
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 6 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD study chair
proDERM GmbH
Dr. rer. nat. Sabrina Laing, MD principal investigator
proDERM GmbH
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 Cream with 0.5% Active and Topical Cream with 1% Active in people with Erythema and Sun Damaged Skin, run by Amazentis SA 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 6 inclusion and 20 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
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?
Erythema (skin redness) assessed by Chromameter (time frame: 3 days). 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 6 Apr 2023.