Back to resultsEvaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream
Primary Purpose
Photoallergy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
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
Challenge: Application of MC2-01 Cream, no irradiation
Challenge: Applications of MC2-01 vehicle, irradiation
Challenge: Applications of MC2-01 vehicle, no irradiation
Challenge: Control, irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Photoallergy
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- TKL Research Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Induction:MC2-01 Cream, irradiation
Induction: MC2-01 Cream, no irradiation
Induction: MC2-01 vehicle, irradiation
Induction: MC2-01 vehicle, no irradiation
Challenge: MC2-01 Cream, irradiation
Challenge: MC2-01 Cream, No irradiation
Challenge: MC2-01 vehicle, irradiation
Challenge: MC2-01 vehicle, no irradiation
Challenge: Control, irradiation
Arm Description
Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
Applications with MC2-01 vehicle, followed by irradiation
Applications with MC2-01 vehicle, no irradiation
Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
Application with MC2-01 vehicle, followed by irradiation
Application with MC2-01 vehicle, no irradiation
No application, but irradiation
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03899064
Brief Title
Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MC2 Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photoallergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
The tests sites (M2-01 Cream, MC2-01 vehicle, control) will not be blinded to the site staff involved in the preparation/application and removal of treatments. The subjects and the trained assessor will be blinded to the IPs and treatment allocation
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Induction:MC2-01 Cream, irradiation
Arm Type
Experimental
Arm Description
Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
Arm Title
Induction: MC2-01 Cream, no irradiation
Arm Type
Experimental
Arm Description
Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
Arm Title
Induction: MC2-01 vehicle, irradiation
Arm Type
Experimental
Arm Description
Applications with MC2-01 vehicle, followed by irradiation
Arm Title
Induction: MC2-01 vehicle, no irradiation
Arm Type
Experimental
Arm Description
Applications with MC2-01 vehicle, no irradiation
Arm Title
Challenge: MC2-01 Cream, irradiation
Arm Type
Experimental
Arm Description
Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
Arm Title
Challenge: MC2-01 Cream, No irradiation
Arm Type
Experimental
Arm Description
Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
Arm Title
Challenge: MC2-01 vehicle, irradiation
Arm Type
Experimental
Arm Description
Application with MC2-01 vehicle, followed by irradiation
Arm Title
Challenge: MC2-01 vehicle, no irradiation
Arm Type
Experimental
Arm Description
Application with MC2-01 vehicle, no irradiation
Arm Title
Challenge: Control, irradiation
Arm Type
Experimental
Arm Description
No application, but irradiation
Intervention Type
Drug
Intervention Name(s)
Induction: Application of MC2-01 Cream, irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Induction: Application of MC2-01 Cream, no irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Induction: Applications of MC2-01 vehicle, irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Induction: Applications of MC2-01 vehicle, no irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Challenge: Application of MC2-01 Cream, irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Challenge: Application of MC2-01 Cream, no irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Challenge: Applications of MC2-01 vehicle, irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Challenge: Applications of MC2-01 vehicle, no irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Challenge: Control, irradiation
Intervention Description
No application, but irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
24 hours
Title
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.
Description
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.
Time Frame
48 hours
Title
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.
Description
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.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S Dosik, MD
Organizational Affiliation
TKL Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
TKL Research Inc.
City
Fair Lawn
State/Province
New Jersey
ZIP/Postal Code
07410
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Single site study
Learn more about this trial
Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream
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