Skin IrritationEarly Phase 1NCT02968446
Effect of Vitamin D After Application With Valchlor
A Early Phase 1 study testing 4 Vitamin D and Valchlor in people with Skin Irritation, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the effects of an oral Vitamin D on the body's immune system. An interest has been growing because studies have shown that Vitamin D may reduce inflammation and harmful effects in the body, however, the best dose for Vitamin D is still unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Irritation
- What is being tested?
- 4 Vitamin D and Valchlor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2016to 1 Oct 2018
- Phase
- Early 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be in general good health
- Fitzpatrick Skin Type I-VI
- Able to list all current medications and medical conditions
- Capable of giving informed consent
Who cannot join
- Women who are pregnant, nursing, or who may become pregnant in the next 3 months
- Participants taking illegal drugs
- Currently taking ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil
- Currently consuming 800IU or more of vitamin D a day
- Subjects whose BMI are > 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor
The purpose of this research study is to evaluate the effects of an oral Vitamin D on the body's immune system.
An interest has been growing because studies have shown that Vitamin D may reduce inflammation and harmful effects in the body, however, the best dose for Vitamin D is still unknown.
Inflammation is the body's physical response to infection, injury, or long term disease. Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the body. This study will look at product use, testing skin irritation in healthy volunteers and seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could one day help doctors prescribe Vitamin D to patients with long term disease to relieve their symptoms.
Read the detailed description
Primary Endpoint To determine the effect of a topical application of Valchlor on human subjects at the clinically approved dose.
Secondary Endpoint To establish the efficacy of cholecalciferol (vitamin D3) in reducing skin irritation 48 hours after topical application of Valchlor.
- Conditions
- Skin Irritation
- Being tested
- 4 placebo, 4 Vitamin D, Valchlor
- Keywords
- Valchlor, Vitamin D, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 placeboDietary supplement
Also called placebo
subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills
4 Vitamin DDietary supplement
Also called cholecalciferol
subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
ValchlorDrug
Also called Mechlorethamine
Twice during the study, subjects will be given 0.016% Valchlor at 3 locations (for a total of 6 locations) in the inner arm using Finn ChambersTM
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 4 placebo - 0 Vitamin D with Valchlor | Placebo comparator | Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor. Receives: Dietary Supplement: 4 placebo; Drug: Valchlor |
| Group 2: 0 placebo - 4 Vitamin D with mechloroethamine | Experimental | Participants will be given 0 placebo capsules and 4 cholecalciferol capsules to total 200,000 IU of cholecalciferol (Vitamin D) after being treated with Valchlor. Receives: Dietary Supplement: 4 Vitamin D; Drug: Valchlor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin erythema
Skin erythema (redness) will be quantified using a CR300 chromameter. The difference in erythema between exposed and non-exposed skin will be calculated after valchlor exposure
Measured: Up to 1 week after mechloroethamine exposure
Secondary outcomes (3)
Change in skin thickness
Skin thickness, an acute measure of edema, was quantified using a Mitutoyo 9mm dial caliper. Thickness measurements will be repeated in triplicate and the mean was used for all calculations. The difference in thickness between exposed and non-exposed skin will be calculated after valchlor exposure.
Measured: Up to 1 week after mechloroethamine exposure
Change in TNF-alpha expression
A 6 mm punch biopsy specimen will be obtained from the valchlor exposure site 48hr after exposure. RNA will be extracted from fresh frozen punch biopsies using the RNeasy Lipid Mini Kit, and tissue mRNA expression of TNF-α will be quantified
Measured: Up to 120 hours after mechloroethamine exposure
Change in iNOS expression
A 6 mm punch biopsy specimen will be obtained from the valchlor exposure site 48hr after exposure. RNA will be extracted from fresh frozen punch biopsies using the RNeasy Lipid Mini Kit, and tissue mRNA expression of iNOS will be quantified
Measured: Up to 120 hours after mechloroethamine exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start17 Nov 2016
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
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 IrritationStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Kurt Lu, University Hospitals Cleveland Medical Center
- Investigators
- Kurt Lu, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968446
- Sponsor's protocol ID
- 09-16-36C
- Other IDs
- U01AR064144-01, CASE3416
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2016
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ernst MK, Evans ST, Techner JM, Rothbaum RM, Christensen LF, Onay UV, Biyashev D, Demczuk MM, Nguyen CV, Honda KS, McCormick TS, Tsoi LC, Gudjonsson JE, Cooper KD, Lu KQ. Vitamin D3 and deconvoluting a rash. JCI Insight. 2023 Jan 24;8(2):e163789. doi: 10.1172/jci.insight.163789.
PubMed 36692020
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor
- ClinicalTrials.gov ID
- NCT02968446
- Acronym / sponsor ID
- 09-16-36C
- Conditions
- Skin Irritation
- Keywords
- Valchlor, Vitamin D, Healthy Volunteer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 18 Nov 2016 (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 purpose of this research study is to evaluate the effects of an oral Vitamin D on the body's immune system.
An interest has been growing because studies have shown that Vitamin D may reduce inflammation and harmful effects in the body, however, the best dose for Vitamin D is still unknown.
Inflammation is the body's physical response to infection, injury, or long term disease. Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the body. This study will look at product use, testing skin irritation in healthy volunteers and seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could one day help doctors prescribe Vitamin D to patients with long term disease to relieve their symptoms.
Detailed description
Primary Endpoint To determine the effect of a topical application of Valchlor on human subjects at the clinically approved dose.
Secondary Endpoint To establish the efficacy of cholecalciferol (vitamin D3) in reducing skin irritation 48 hours after topical application of Valchlor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: 4 placebo - 0 Vitamin D with Valchlor | Placebo comparator | Dietary Supplement: 4 placebo, Drug: ValchlorParticipants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor. |
| Group 2: 0 placebo - 4 Vitamin D with mechloroethamine | Experimental | Dietary Supplement: 4 Vitamin D, Drug: ValchlorParticipants will be given 0 placebo capsules and 4 cholecalciferol capsules to total 200,000 IU of cholecalciferol (Vitamin D) after being treated with Valchlor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be in general good health
- Fitzpatrick Skin Type I-VI
- Able to list all current medications and medical conditions
- Capable of giving informed consent
Key exclusion criteria (5 listed)
- Women who are pregnant, nursing, or who may become pregnant in the next 3 months
- Participants taking illegal drugs
- Currently taking ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil
- Currently consuming 800IU or more of vitamin D a day
- Subjects whose BMI are > 40
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 |
|---|---|---|
| 4 placeboAlso: placebosubjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills | Dietary supplement | Group 1: 4 placebo - 0 Vitamin D with Valchlor |
| 4 Vitamin DAlso: cholecalciferolsubjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol) | Dietary supplement | Group 2: 0 placebo - 4 Vitamin D with mechloroethamine |
| ValchlorAlso: MechlorethamineTwice during the study, subjects will be given 0.016% Valchlor at 3 locations (for a total of 6 locations) in the inner arm using Finn ChambersTM | Drug | Group 1: 4 placebo - 0 Vitamin D with Valchlor, Group 2: 0 placebo - 4 Vitamin D with mechloroethamine |
Primary outcome
Change in skin erythema
Time frame: Up to 1 week after mechloroethamine exposure
Skin erythema (redness) will be quantified using a CR300 chromameter. The difference in erythema between exposed and non-exposed skin will be calculated after valchlor exposure
3 secondary outcomes
Change in skin thickness
Time frame: Up to 1 week after mechloroethamine exposure
Change in TNF-alpha expression
Time frame: Up to 120 hours after mechloroethamine exposure
Change in iNOS expression
Time frame: Up to 120 hours after mechloroethamine exposure
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 23 Dec 2021.
- Derived from this study: PubMed 36692020Ernst MK, Evans ST, Techner JM, Rothbaum RM, Christensen LF, Onay UV, Biyashev D, Demczuk MM, Nguyen CV, Honda KS, McCormick TS, Tsoi LC, Gudjonsson JE, Cooper KD, Lu KQ. Vitamin D3 and deconvoluting a rash. JCI Insight. 2023 Jan 24;8(2):e163789. doi: 10.1172/jci.insight.163789.
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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.
Kurt Lu, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 4 Vitamin D and Valchlor in people with Skin Irritation, run by University Hospitals Cleveland Medical Center 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 4 inclusion and 5 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 23 Dec 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in skin erythema (time frame: Up to 1 week after mechloroethamine exposure). 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 NCT02968446, 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 23 Dec 2021.