ErythemaPhase 1NCT01301677
Ultra Violet B Radiation (UVR) Study of Strontium Chloride Hexahydrate Hydrocortisone
A Phase 1 study testing Hydrocortisone, 2PX+ and 2PX- in people with Erythema and Pain, run by X-pert Med GmbH at 2 sites in Germany.
Trial summary
Double blinded (subject and observer), randomised, active (hydrocortisone (HC)) controlled study of the effect of strontium chloride hexahydrate on ultraviolet B radiation (UVR) induced signs of inflammation (erythema and pain) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Hydrocortisone, 2PX+ and 2PX-
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2011to Jun 2011
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent prior to any study-mandated procedure
- Subjects in good health as determined by the Investigator
- Willing and able to comply with study requirements
- Age ≥ 18
- Fitzpatrick skin types I, II, or III
- Willing to avoid sun exposure, tanning lamps and use of any topical products on the test areas during the study
Show all 9Show fewer
- Willing not to wash test areas during treatment period
- Willing to abstain from sauna, exposure to extreme cold or major physical activities during the treatment period of the study
- For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation
Who cannot join
- General
- Planned treatment or treatment with another investigational drug within 30 days prior to randomization.
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions
- Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- Pregnancy or lactation
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
Show all 18Show fewer
- Medical History
- Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma
- Known hypersensitivity or allergy (including photoallergy) to hydrocortisone, strontium chloride hexahydrate, glycofurol, dimethylsulphoxide (DMSO), ethanol, propylene glycol, glycerol, hypomellose, sodium edentate, sodium hydroxide, citric acid monohydrate and metagin
- History of photosensitivity disease
- Sunburn, excessive tan, uneven skin tones or blemishes of the test areas
- Pain conditions which might interfere with pain rating during the study, e.g. neuropathic pain
- Open wounds, infection, inflammation or other dermal diseases of the intended application areas
- ALT or AST ≥ 5 times the ULN
- Glomerulary filtration rate < 30 ml/min
- Medication History
- Systemic or topical drugs that might affect responses to UVR or interfere with responses to IMP including corticosteroids, thiazides, tetracyclines and NSAIDs must be washed out with 5 times half-life time prior to randomization to treatment
- Drugs with potential dermatologic adverse events defined by the respective summary of product characteristics (e.g. tetracyclines, gyrase inhibitors) must be washed out with 5 times half-life time prior to randomization to treatment
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
X-pert Med GmbH
Gräfelfing, Bavaria, 82166
X-pert Med Gmbh
Jena, Thuringia, 07745
About this study
Official title: Double-blind, Randomised, Active (Hydrocortisone) Controlled Study of the Effect of 10% w/v Strontium Chloride Hexahydrate on Ultraviolet B Radiation (UVR) Induced Signs of Inflammation (Erythema and Pain) in Healthy Volunteers
Double blinded (subject and observer), randomised, active (hydrocortisone (HC)) controlled study of the effect of strontium chloride hexahydrate on ultraviolet B radiation (UVR) induced signs of inflammation (erythema and pain) in healthy volunteers.
Read the detailed description
Subjects that signed the informed consent and are eligible to the study will be irradiated on the back to evaluate their individual minimal erythema dose (MED).
A training session (without study medication) will be performed in order to introduce subjects to the testing and rating procedures.
Subjects will come in within 28 days of screening to start the treatment period of the study.
For eligible subjects, three test areas oriented along the long axis of the back and different from the areas of MED determination will be defined for the evaluation of effects on pain and inflammation induced by UVR. The three areas will be irradiated with 2 MED. In addition, non-irradiated, not treated areas will serve as reference and training areas for the individual visits.
Topical treatments will be randomly assigned to the three test areas.
- Being tested
- Hydrocortisone, 2PX+, 2PX-
- Medical subject headings
- Erythema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Hydrocortisone liquid formulation
2PX+Drug
strontium chloride hexahydrate in a penetration enhancing vehicle
2PX-Drug
strontium chloride hexahydrate without a penetration enhancing vehicle
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Active comparator | Not described Receives: Drug: Hydrocortisone |
| 2PX+ | Experimental | strontium chloride hexahydrate in a penetration enhancing vehicle Receives: Drug: 2PX+ |
| 2PX- | Experimental | strontium chloride hexahydrate without a penetration enhancing vehicle Receives: Drug: 2PX- |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of erythema
Measured: at 6 h, 12 h, 24 h, 36 h, 48 h post UVR
Secondary outcomes (1)
Pain threshold (primary hyperalgesia to heat)
Measured: Sum of assessments at 6 h, 12 h, 24 h, 36 h, 48 h post UVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionJun 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- X-pert Med GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ilka Rother, MD, Principal investigator, X-pert Med GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301677
- Sponsor's protocol ID
- XPM-033
- Status last verified
- Jun 2011
- First submitted
- 17 Feb 2011
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Active (Hydrocortisone) Controlled Study of the Effect of 10% w/v Strontium Chloride Hexahydrate on Ultraviolet B Radiation (UVR) Induced Signs of Inflammation (Erythema and Pain) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01301677
- Acronym / sponsor ID
- XPM-033
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- X-pert Med GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Feb 2011 (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.
Double blinded (subject and observer), randomised, active (hydrocortisone (HC)) controlled study of the effect of strontium chloride hexahydrate on ultraviolet B radiation (UVR) induced signs of inflammation (erythema and pain) in healthy volunteers.
Detailed description
Subjects that signed the informed consent and are eligible to the study will be irradiated on the back to evaluate their individual minimal erythema dose (MED).
A training session (without study medication) will be performed in order to introduce subjects to the testing and rating procedures.
Subjects will come in within 28 days of screening to start the treatment period of the study.
For eligible subjects, three test areas oriented along the long axis of the back and different from the areas of MED determination will be defined for the evaluation of effects on pain and inflammation induced by UVR. The three areas will be irradiated with 2 MED. In addition, non-irradiated, not treated areas will serve as reference and training areas for the individual visits.
Topical treatments will be randomly assigned to the three test areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Active comparator | Drug: Hydrocortisone |
| 2PX+ | Experimental | Drug: 2PX+strontium chloride hexahydrate in a penetration enhancing vehicle |
| 2PX- | Experimental | Drug: 2PX-strontium chloride hexahydrate without a penetration enhancing vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent prior to any study-mandated procedure
- Subjects in good health as determined by the Investigator
- Willing and able to comply with study requirements
- Age ≥ 18
- Fitzpatrick skin types I, II, or III
Key exclusion criteria (18 listed)
- General
- Planned treatment or treatment with another investigational drug within 30 days prior to randomization.
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions
- Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- Pregnancy or lactation
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 |
|---|---|---|
| HydrocortisoneHydrocortisone liquid formulation | Drug | Hydrocortisone |
| 2PX+strontium chloride hexahydrate in a penetration enhancing vehicle | Drug | 2PX+ |
| 2PX-strontium chloride hexahydrate without a penetration enhancing vehicle | Drug | 2PX- |
Primary outcome
Degree of erythema
Time frame: at 6 h, 12 h, 24 h, 36 h, 48 h post UVR
1 secondary outcome
Pain threshold (primary hyperalgesia to heat)
Time frame: Sum of assessments at 6 h, 12 h, 24 h, 36 h, 48 h post UVR
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 29 Jun 2011.
Related trials for Erythema
RecruitingPhase 2
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
Erythema Nodosum Leprosum
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Not yet recruiting
The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Facial Erythema and Other Skin Parameters
Erythema, Telangiectasis
RecruitingObservational study
Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures
Post Procedural Erythema
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
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.
Ilka Rother, MD principal investigator
X-pert Med GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydrocortisone, 2PX+ and 2PX- in people with Erythema and Pain, run by X-pert Med GmbH at 2 sites 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 9 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 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Degree of erythema (time frame: at 6 h, 12 h, 24 h, 36 h, 48 h post UVR). 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 29 Jun 2011.