PhotoallergyPhase 1NCT03899064
Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream
A Phase 1 study testing Induction: Application of MC2-01 Cream, irradiation, Induction: Application of MC2-01 Cream, no irradiation and Challenge: Application of MC2-01 Cream, irradiation in people with Photoallergy, run by MC2 Therapeutics at 1 site in United States.
Trial summary
This trial is a 6-week, Randomized study evaluating the potential of MC2-01 Cream to induce a photoallergic skin reaction in Healthy subjects, using a controlled photopatch test design. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photoallergy
- What is being tested?
- Induction: Application of MC2-01 Cream, irradiation, Induction: Application of MC2-01 Cream, no irradiation and Challenge: Application of MC2-01 Cream, irradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to 5 Apr 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 or 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 childbearing potential, has had a hysterectomy or is postmenopausal
Show all 10Show fewer
- 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
Show all 21Show fewer
- 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 6-Week, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce Photoallergic Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design
This trial is a 6-week, Randomized study evaluating the potential of MC2-01 Cream to induce a photoallergic skin reaction in Healthy subjects, using a controlled photopatch test design.
Read the detailed description
The study evaluates the potential of MC2-01(CAL/BDP 0.005/0.064 w/w%) Cream to induce a photoallergic skin reaction. Because MC2-01 Cream is formulated for topical use and has shown to absorb light within the range of natural sunlight, it is necessary to determine the potential of this product to cause a photoallergic reaction after application to the skin.
- Conditions
- Photoallergy
- Being tested
- Induction: Application of MC2-01 Cream, irradiation, Induction: Application of MC2-01 Cream, no irradiation, Induction: Applications of MC2-01 vehicle, irradiation, Induction: Applications of MC2-01 vehicle, no irradiation, Challenge: Application of MC2-01 Cream, irradiation
- Medical subject headings
- Dermatitis, Photoallergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction: Application of MC2-01 Cream, irradiationDrug
Repeated applications of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), 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
Induction: Application of MC2-01 Cream, no irradiationDrug
Repeated applications 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
Induction: Applications of MC2-01 vehicle, irradiationDrug
Repeated applications 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
Induction: Applications of MC2-01 vehicle, no irradiationDrug
Repeated applications 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
Challenge: Application of MC2-01 Cream, irradiationDrug
Single application of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
Challenge: Application of MC2-01 Cream, no irradiationDrug
Single 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 and edema
Challenge: Applications of MC2-01 vehicle, irradiationDrug
Single application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
Challenge: Applications of MC2-01 vehicle, no irradiationDrug
Single application of MC2-01 vehicle, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
Challenge: Control, irradiationDrug
No application, but irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
| Study group | Role | What they receive |
|---|---|---|
| Induction:MC2-01 Cream, irradiation | Experimental | Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation Receives: Drug: Induction: Application of MC2-01 Cream, irradiation |
| Induction: MC2-01 Cream, no irradiation | Experimental | Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation Receives: Drug: Induction: Application of MC2-01 Cream, no irradiation |
| Induction: MC2-01 vehicle, irradiation | Experimental | Applications with MC2-01 vehicle, followed by irradiation Receives: Drug: Induction: Applications of MC2-01 vehicle, irradiation |
| Induction: MC2-01 vehicle, no irradiation | Experimental | Applications with MC2-01 vehicle, no irradiation Receives: Drug: Induction: Applications of MC2-01 vehicle, no irradiation |
| Challenge: MC2-01 Cream, irradiation | Experimental | Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation Receives: Drug: Challenge: Application of MC2-01 Cream, irradiation |
| Challenge: MC2-01 Cream, No irradiation | Experimental | Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation Receives: Drug: Challenge: Application of MC2-01 Cream, no irradiation |
| Challenge: MC2-01 vehicle, irradiation | Experimental | Application with MC2-01 vehicle, followed by irradiation Receives: Drug: Challenge: Applications of MC2-01 vehicle, irradiation |
| Challenge: MC2-01 vehicle, no irradiation | Experimental | Application with MC2-01 vehicle, no irradiation Receives: Drug: Challenge: Applications of MC2-01 vehicle, no irradiation |
| Challenge: Control, irradiation | Experimental | No application, but irradiation Receives: Drug: Challenge: Control, irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.
After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated.
MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another naive test site was untreated. 24 hours after product application, one of each test site (MC2-01 Cream, MC2-01 vehicle) + the untreated site were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 5 test sites 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study.
The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.
Measured: 24 hours
Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.
After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated.
MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another two naive test sites were untreated. 24 hours of product application, one of each test site (MC2-01 Cream, MC2-01 vehicle and untreated) were irradiated.
Possible changes in dermal reaction (erythema and edema) was evaluated at all 6 test sites, 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study. The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.
Measured: 48 hours
Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.
After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated.
MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another two naive test sites were untreated. 24 hours of product application, one of each test site (MC2-01 Cream, MC2-01 vehicle and untreated) were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 6 test sites, 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study.
The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start13 Feb 2019
- Primary completion5 Apr 2019
- Study completion5 Apr 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 PhotoallergyStudies 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
- The study consist of an Induction phase, where treatments (MC2-01 Cream, MC2-01 vehicle) were applied to 2 test sites each (n=4), followed by irradiation/non-irradiation and evaluation 24, 48 or 72 hours post-irradiation. This was repeated in total 6 times over an 3 weeks period. The induction phase was followed by a challenge phase, where treatments (MC2-01 Cream, MC2-01 vehicle) were applied to each two naive test sites and another naive test site was untreated. 24 hours of product application, one of each test sites (MC2-01 Cream, MC2-01 vehicle) + the untreated test site were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 5 test sites, 24, 48 and 72 hours post-irradiation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- MC2 Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan S Dosik, MD, Principal investigator, TKL Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899064
- Sponsor's protocol ID
- MC2-01-C10
- Status last verified
- Feb 2020
- First submitted
- 20 Mar 2019
- Last updated
- 11 Mar 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 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce Photoallergic Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design
- ClinicalTrials.gov ID
- NCT03899064
- Acronym / sponsor ID
- MC2-01-C10
- Conditions
- Photoallergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- MC2 TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Posted 11 Mar 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 6-week, Randomized study evaluating the potential of MC2-01 Cream to induce a photoallergic skin reaction in Healthy subjects, using a controlled photopatch test design.
Detailed description
The study evaluates the potential of MC2-01(CAL/BDP 0.005/0.064 w/w%) Cream to induce a photoallergic skin reaction. Because MC2-01 Cream is formulated for topical use and has shown to absorb light within the range of natural sunlight, it is necessary to determine the potential of this product to cause a photoallergic reaction after application to the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 9
- Model description
- The study consist of an Induction phase, where treatments (MC2-01 Cream, MC2-01 vehicle) were applied to 2 test sites each (n=4), followed by irradiation/non-irradiation and evaluation 24, 48 or 72 hours post-irradiation. This was repeated in total 6 times over an 3 weeks period. The induction phase was followed by a challenge phase, where treatments (MC2-01 Cream, MC2-01 vehicle) were applied to each two naive test sites and another naive test site was untreated. 24 hours of product application, one of each test sites (MC2-01 Cream, MC2-01 vehicle) + the untreated test site were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 5 test sites, 24, 48 and 72 hours post-irradiation.
| Arm | Type | Receives |
|---|---|---|
| Induction:MC2-01 Cream, irradiation | Experimental | Drug: Induction: Application of MC2-01 Cream, irradiationApplications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation |
| Induction: MC2-01 Cream, no irradiation | Experimental | Drug: Induction: Application of MC2-01 Cream, no irradiationApplications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation |
| Induction: MC2-01 vehicle, irradiation | Experimental | Drug: Induction: Applications of MC2-01 vehicle, irradiationApplications with MC2-01 vehicle, followed by irradiation |
| Induction: MC2-01 vehicle, no irradiation | Experimental | Drug: Induction: Applications of MC2-01 vehicle, no irradiationApplications with MC2-01 vehicle, no irradiation |
| Challenge: MC2-01 Cream, irradiation | Experimental | Drug: Challenge: Application of MC2-01 Cream, irradiationApplication with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation |
| Challenge: MC2-01 Cream, No irradiation | Experimental | Drug: Challenge: Application of MC2-01 Cream, no irradiationApplication with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation |
| Challenge: MC2-01 vehicle, irradiation | Experimental | Drug: Challenge: Applications of MC2-01 vehicle, irradiationApplication with MC2-01 vehicle, followed by irradiation |
| Challenge: MC2-01 vehicle, no irradiation | Experimental | Drug: Challenge: Applications of MC2-01 vehicle, no irradiationApplication with MC2-01 vehicle, no irradiation |
| Challenge: Control, irradiation | Experimental | Drug: Challenge: Control, irradiationNo application, but irradiation |
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 or 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 |
|---|---|---|
| Induction: Application of MC2-01 Cream, irradiationRepeated applications of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), 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 | Induction:MC2-01 Cream, irradiation |
| Induction: Application of MC2-01 Cream, no irradiationRepeated applications 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 | Drug | Induction: MC2-01 Cream, no irradiation |
| Induction: Applications of MC2-01 vehicle, irradiationRepeated applications 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 | Induction: MC2-01 vehicle, irradiation |
| Induction: Applications of MC2-01 vehicle, no irradiationRepeated applications 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 | Drug | Induction: MC2-01 vehicle, no irradiation |
| Challenge: Application of MC2-01 Cream, irradiationSingle application of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema | Drug | Challenge: MC2-01 Cream, irradiation |
| Challenge: Application of MC2-01 Cream, no irradiationSingle 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 and edema | Drug | Challenge: MC2-01 Cream, No irradiation |
| Challenge: Applications of MC2-01 vehicle, irradiationSingle application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema | Drug | Challenge: MC2-01 vehicle, irradiation |
| Challenge: Applications of MC2-01 vehicle, no irradiationSingle application of MC2-01 vehicle, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema | Drug | Challenge: MC2-01 vehicle, no irradiation |
| Challenge: Control, irradiationNo application, but irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema | Drug | Challenge: Control, irradiation |
Primary outcome
Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.
Time frame: 24 hours
After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated. MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another naive test site was untreated. 24 hours after product application, one of each test site (MC2-01 Cream, MC2-01 vehicle) + the untreated site were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 5 test sites 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study. The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.
Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.
Time frame: 48 hours
After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated. MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another two naive test sites were untreated. 24 hours of product application, one of each test site (MC2-01 Cream, MC2-01 vehicle and untreated) were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 6 test sites, 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study. The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.
Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.
Time frame: 72 hours
After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated. MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another two naive test sites were untreated. 24 hours of product application, one of each test site (MC2-01 Cream, MC2-01 vehicle and untreated) were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 6 test sites, 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study. The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Single site study
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 Dosik, MD principal investigator
TKL Research
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 Induction: Application of MC2-01 Cream, irradiation, Induction: Application of MC2-01 Cream, no irradiation and Challenge: Application of MC2-01 Cream, irradiation in people with Photoallergy, 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 11 Mar 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 11 Mar 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 of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation. (time frame: 24 hours). 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 11 Mar 2020.