PhototoxicityPhase 1NCT03892564
Evaluation of Potential Phototoxicity Skin Reaction After Use of MC2-01 Cream
A Phase 1 study testing MC2-01 Cream, irradiation and MC2-01 Cream, no irradiation in people with Phototoxicity, run by MC2 Therapeutics at 1 site in United States.
Trial summary
This trial is a 4-day, randomized study to determine the phototoxic potential of MC2-01 Cream when topical application to healthy skin is followed by light exposure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Phototoxicity
- What is being tested?
- MC2-01 Cream, irradiation and MC2-01 Cream, no irradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2019to 9 Mar 2019
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a healthy male or female
- Is 18 years of age or older
- Agree not to participate in any clinical or patch test studies at Day 1 through study completion
- Females of childbearing potential must use a highly effective method of contraception for one month prior to Screening and until the end of study visit has been performed
- in the case of a female of childbearing potential, has a negative urine pregnancy test on Day 1 prior to randomization and are willing to submit to a urine pregnancy test at the end of study
- In the case of a female of non-childbearing potential, has had a hysterectomy or is postmenopausal
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- Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.
- Has uniformly-colored skin on the intrascapular region of the back which will allow discernment of erythema, and has Fitzpatrick skin types I, II or III
- Complete a medical screening procedure
- Read, understand and sign an informed consent
Who cannot join
- Has a history of photosensitivity or photoallergy
- Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction
- Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency or severe hepatic disorders
- Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study or systemic/topical antihistamines 72 hours prior to and during the study
- Is not willing to refrain from using systemic/topical anti-inflammatory analgesics (81 mg aspirin and occasional use of acetaminophen will be permitted)
- Are taking medication known to cause phototoxic reaction
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- Is using medication which, in the opinion of the Investigator, will interfere with the study results
- Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study
- Has psoriasis and/or atopic dermatitis/eczema
- Has a known sensitivity or allergy to constituents of the materials being evaluated
- Is a female who is pregnant, plans to become pregnant during the study, or is breast feeding a child
- Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars excessive hair, numerous freckles or other disfigurations of the test site
- Has received treatment for any type of internal cancer within 5 years prior to study entry
- Has a history of, or are currently being treated for skin cancer and/or hepatitis
- Has a history or, or is currently being treated for diabetes
- Has any condition that might compromise study results
- Is expected to sunbathe or use tanning salons during the study
- Has a history of adverse response to UV-sun lamps/sunlight exposure
- Is currently participating in any clinical testing
- Has any known sensitivity to adhesives
- Has received any investigational drug(s) within 28 days from Day 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 4-Day, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce a Phototoxicity Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design
This trial is a 4-day, randomized study to determine the phototoxic potential of MC2-01 Cream when topical application to healthy skin is followed by light exposure.
Read the detailed description
This study evaluates the potential of MC2-01 (CAL/BDP 0.005/0.042w/w%) Cream to cause a phototoxic reaction using a controlled photopatch test design. Because MC2-01 Cream is formulated for topical use and have shown to absorb light, it is necessary to determine the potential of this product to cause a phototoxic reaction after topical application and irradiation of the skin.
- Conditions
- Phototoxicity
- Being tested
- MC2-01 Cream, irradiation, MC2-01 Cream, no irradiation, MC2-01 vehicle, irradiation, MC2-01 vehicle, no irradiation, Control, irradiation
- Medical subject headings
- Dermatitis, Phototoxic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC2-01 Cream, irradiationDrug
One application of MC2-01 Cream, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
MC2-01 Cream, no irradiationDrug
One application of MC2-01 Cream. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
MC2-01 vehicle, irradiationDrug
One application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
MC2-01 vehicle, no irradiationDrug
One application of MC2-01 vehicle. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
Control, irradiationDrug
Untreated, irradiated site. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
| Study group | Role | What they receive |
|---|---|---|
| MC2-01 Cream, irradiation | Experimental | One applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation Receives: Drug: MC2-01 Cream, irradiation |
| MC2-01 Cream, no irradiation | Experimental | One application of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation Receives: Drug: MC2-01 Cream, no irradiation |
| MC2-01 vehicle, irradiation | Experimental | One application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation Receives: Drug: MC2-01 vehicle, irradiation |
| MC2-01 vehicle, no irradiation | Experimental | One application of MC2-01 vehicle, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation Receives: Drug: MC2-01 vehicle, no irradiation |
| Control, irradiation | Experimental | Untreated, irradiated site. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation Receives: Drug: Control, irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation
MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study
Measured: Baseline, before irradiation
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation
MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study
Measured: 24h post-irradiation
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation
MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study
Measured: 48h post-irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start27 Feb 2019
- Primary completion9 Mar 2019
- Study completion9 Mar 2019
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.
- Other trials for PhototoxicityStudies 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
- Parallel groups
- Model description
- One treatment with MC2-01 Cream, MC2-01 vehicle and control on defined applications site (N=5), followed by irradiation/non-irradiation and evaluation 24 or 48 hours post irradiation, within subject comparison model
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- MC2 Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan S Dorsik, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892564
- Sponsor's protocol ID
- MC2-01-C9
- Status last verified
- Feb 2020
- First submitted
- 20 Mar 2019
- Last updated
- 12 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Single site study
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Day, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce a Phototoxicity Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design
- ClinicalTrials.gov ID
- NCT03892564
- Acronym / sponsor ID
- MC2-01-C9
- Conditions
- Phototoxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- MC2 TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 9 Mar 2019 (actual)
- Study completion
- 9 Mar 2019 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a 4-day, randomized study to determine the phototoxic potential of MC2-01 Cream when topical application to healthy skin is followed by light exposure.
Detailed description
This study evaluates the potential of MC2-01 (CAL/BDP 0.005/0.042w/w%) Cream to cause a phototoxic reaction using a controlled photopatch test design. Because MC2-01 Cream is formulated for topical use and have shown to absorb light, it is necessary to determine the potential of this product to cause a phototoxic reaction after topical application and irradiation of the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- One treatment with MC2-01 Cream, MC2-01 vehicle and control on defined applications site (N=5), followed by irradiation/non-irradiation and evaluation 24 or 48 hours post irradiation, within subject comparison model
| Arm | Type | Receives |
|---|---|---|
| MC2-01 Cream, irradiation | Experimental | Drug: MC2-01 Cream, irradiationOne applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation |
| MC2-01 Cream, no irradiation | Experimental | Drug: MC2-01 Cream, no irradiationOne application of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation |
| MC2-01 vehicle, irradiation | Experimental | Drug: MC2-01 vehicle, irradiationOne application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation |
| MC2-01 vehicle, no irradiation | Experimental | Drug: MC2-01 vehicle, no irradiationOne application of MC2-01 vehicle, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation |
| Control, irradiation | Experimental | Drug: Control, irradiationUntreated, irradiated site. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is a healthy male or female
- Is 18 years of age or older
- Agree not to participate in any clinical or patch test studies at Day 1 through study completion
- Females of childbearing potential must use a highly effective method of contraception for one month prior to Screening and until the end of study visit has been performed
- in the case of a female of childbearing potential, has a negative urine pregnancy test on Day 1 prior to randomization and are willing to submit to a urine pregnancy test at the end of study
Key exclusion criteria (21 listed)
- Has a history of photosensitivity or photoallergy
- Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction
- Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency or severe hepatic disorders
- Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study or systemic/topical antihistamines 72 hours prior to and during the study
- Is not willing to refrain from using systemic/topical anti-inflammatory analgesics (81 mg aspirin and occasional use of acetaminophen will be permitted)
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 |
|---|---|---|
| MC2-01 Cream, irradiationOne application of MC2-01 Cream, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation | Drug | MC2-01 Cream, irradiation |
| MC2-01 Cream, no irradiationOne application of MC2-01 Cream. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation | Drug | MC2-01 Cream, no irradiation |
| MC2-01 vehicle, irradiationOne application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation | Drug | MC2-01 vehicle, irradiation |
| MC2-01 vehicle, no irradiationOne application of MC2-01 vehicle. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation | Drug | MC2-01 vehicle, no irradiation |
| Control, irradiationUntreated, irradiated site. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation | Drug | Control, irradiation |
Primary outcome
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation
Time frame: Baseline, before irradiation
MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation
Time frame: 24h post-irradiation
MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation
Time frame: 48h post-irradiation
MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Single site study
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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.
Jonathan S Dorsik principal investigator
TKL Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MC2-01 Cream, irradiation and MC2-01 Cream, no irradiation in people with Phototoxicity, run by MC2 Therapeutics 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 10 inclusion and 21 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 12 Feb 2020. 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. 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?
Yes. Results are posted in the registry (first posted 12 Feb 2020). 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?
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation (time frame: Baseline, before irradiation). The study lists 3 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 12 Feb 2020.