Evaluation of Potential Phototoxicity Skin Reaction After Use of MC2-01 Cream
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: MC2-01 Cream, irradiation One applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation |
Drug: MC2-01 Cream, irradiation
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
|
Experimental: MC2-01 Cream, no irradiation 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 |
Drug: MC2-01 Cream, no irradiation
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
|
Experimental: MC2-01 vehicle, irradiation 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 |
Drug: MC2-01 vehicle, irradiation
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
|
Experimental: MC2-01 vehicle, no irradiation 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 |
Drug: MC2-01 vehicle, no irradiation
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
|
Experimental: Control, irradiation 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 |
Drug: Control, irradiation
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
|
Outcome Measures
Primary Outcome Measures
- 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 [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 [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 [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
Eligibility Criteria
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 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
-
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | TKL Research Inc | Fair Lawn | New Jersey | United States | 07410 |
Sponsors and Collaborators
- MC2 Therapeutics
Investigators
- Principal Investigator: Jonathan S Dorsik, TKL Research, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.- MC2-01-C9
Study Results
Participant Flow
Recruitment Details | First Subject First Visit: 27-Feb-2019. Last Subject Last Visit: 09-Mar-2019 |
---|---|
Pre-assignment Detail | The study consist of a screening day + treatment period of 4 consecutive days. The study is a within-subject comparison study of MC2-01 cream and vehicle. The products were each applied to 2 sites; one was irradiated and other non-radiated. The irradiated and non-irradiated sites were compared to each other and with an untreated irradiated site. |
Arm/Group Title | Test Sites |
---|---|
Arm/Group Description | 5 test sites on the subject's back defined as: - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - Control site (no application, only irradiated) to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation |
Period Title: Overall Study | |
STARTED | 35 |
MC2-01 Cream + Irridiation | 35 |
MC2-01 Cream + Non-irridiation | 35 |
MC2-01 Vehicle + Irridiation | 35 |
MC2-01 Vehicle + Non-irridiation | 35 |
Control Site | 35 |
COMPLETED | 33 |
NOT COMPLETED | 2 |
Baseline Characteristics
Arm/Group Title | Test Sites |
---|---|
Arm/Group Description | 5 test sites on the subject's back defined as: - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - Control site (no application, only irradiated) to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation |
Overall Participants | 35 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
55.0
(9.65)
|
Sex: Female, Male (Count of Participants) | |
Female |
31
88.6%
|
Male |
4
11.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
6
17.1%
|
Not Hispanic or Latino |
29
82.9%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
1
2.9%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
0
0%
|
White |
34
97.1%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (participants) [Number] | |
United States |
35
100%
|
Fitzpatrick Skin Type (Count of Participants) | |
II |
9
25.7%
|
III |
26
74.3%
|
Outcome Measures
Title | 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 |
---|---|
Description | 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 |
Time Frame | Baseline, before irradiation |
Outcome Measure Data
Analysis Population Description |
---|
As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream and two sites with MC2-01 vehicle, followed by either irradiation or non-irradiation + a irradiated control site, all subjects received all 5 different treatments. |
Arm/Group Title | Test Sites |
---|---|
Arm/Group Description | - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - control, irradiated |
Measure Participants | 33 |
No erythema/edema |
33
94.3%
|
Mild, definite erythema/edema |
0
0%
|
No erythema/edema |
33
94.3%
|
Mild, definite erythema/edema |
0
0%
|
No erythema/edema |
32
91.4%
|
Mild, definite erythema/edema |
1
2.9%
|
No erythema/edema |
32
91.4%
|
Mild, definite erythema/edema |
1
2.9%
|
No erythema/edema |
33
94.3%
|
Mild, definite erythema/edema |
0
0%
|
Title | 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 |
---|---|
Description | 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 |
Time Frame | 24h post-irradiation |
Outcome Measure Data
Analysis Population Description |
---|
As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream and two sites with MC2-01 vehicle, followed by either irradiation or non-irradiation + a irradiated control site, all subjects received all 5 different treatments. |
Arm/Group Title | Test Sites |
---|---|
Arm/Group Description | 5 test sites on the subject's back defined as: - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - control, irradiated to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation |
Measure Participants | 33 |
No erythema/edema |
21
60%
|
Mild, definite erythema/edema |
12
34.3%
|
No erythema/edema |
33
94.3%
|
Mild, definite erythema/edema |
0
0%
|
No erythema/edema |
21
60%
|
Mild, definite erythema/edema |
12
34.3%
|
No erythema/edema |
33
94.3%
|
Mild, definite erythema/edema |
0
0%
|
No erythema/edema |
21
60%
|
Mild, definite erythema/edema |
12
34.3%
|
Title | 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 |
---|---|
Description | 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 |
Time Frame | 48h post-irradiation |
Outcome Measure Data
Analysis Population Description |
---|
As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream and two sites with MC2-01 vehicle, followed by either irradiation or non-irradiation + a irradiated control site, all subjects received all 5 different treatments. |
Arm/Group Title | Test Sites |
---|---|
Arm/Group Description | 5 test sites on the subject's back defined as: - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - control, irradiated to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation |
Measure Participants | 33 |
No erythema/edema |
25
71.4%
|
Mild, definite erythema/edema |
8
22.9%
|
No erythema/edema |
33
94.3%
|
Mild, definite erythema/edema |
0
0%
|
No erythema/edema |
25
71.4%
|
Mild, definite erythema/edema |
8
22.9%
|
No erythema/edema |
33
94.3%
|
Mild, definite erythema/edema |
0
0%
|
No erythema/edema |
25
71.4%
|
Mild, definite erythema/edema |
8
22.9%
|
Adverse Events
Time Frame | AEs were collected/assessed from the time of the informed consent form was signed by the subject at the screening visit and during the test phase, which consisted of in total of 4 days. the 4th day was considered the last visit for the subjects. AEs assessed as reasonably possibly related to the trial medication had to be followed until they were resolved or until the medical condition of the subject was stable. | |
---|---|---|
Adverse Event Reporting Description | 35 patients participated in the study and all patients received all 5 types of treatments. Therefore data for the 'All-Cause Mortality', 'Serious Adverse Events' and 'Other Adverse Events' fields are included and assessed for all types of medication. | |
Arm/Group Title | MC2-01 Cream, Irradiation | |
Arm/Group Description | 5 test sites on the subject's back defined as: - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - control, irradiated | |
All Cause Mortality |
||
MC2-01 Cream, Irradiation | ||
Affected / at Risk (%) | # Events | |
Total | 0/35 (0%) | |
Serious Adverse Events |
||
MC2-01 Cream, Irradiation | ||
Affected / at Risk (%) | # Events | |
Total | 0/35 (0%) | |
Other (Not Including Serious) Adverse Events |
||
MC2-01 Cream, Irradiation | ||
Affected / at Risk (%) | # Events | |
Total | 0/35 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Birgitte Vestbjerg |
---|---|
Organization | MC2 Therapeutics |
Phone | +45 2077 2575 |
bve@mc2therapeutics.com |
- MC2-01-C9