Trial Outcomes & Findings for Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream (NCT NCT03899064)
NCT ID: NCT03899064
Last Updated: 2020-03-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
58 participants
Primary outcome timeframe
24 hours
Results posted on
2020-03-11
Participant Flow
First Subject First Visit: 18-Feb-2019; Last Subject Last Visit: 05-Apr-2019
This study was a randomized, double-blind, controlled, within-subject comparison study to evaluate the potential of MC2-01 cream to induce a photoallergic skin reaction. The study consist of a 3-week Induction phase, followed by a Challenge phase.
Participant milestones
| Measure |
Test Sites
5 test sites on the subject's back defined as:
1. Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
2. Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
3. Applications with MC2-01 vehicle, followed by irradiation
4. Applications with MC2-01 vehicle, no irradiation
5. No application, but irradiation
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
MC2-01 Cream, Irradiation
|
58
|
|
Overall Study
MC2-01 Cream, No Irradiation
|
58
|
|
Overall Study
MC2-01 Vehicle, Irradiation
|
58
|
|
Overall Study
MC2-01 Vehicle, no Irradiation
|
58
|
|
Overall Study
Control, Irradiation
|
58
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Test Sites
5 test sites on the subject's back defined as:
1. Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
2. Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
3. Applications with MC2-01 vehicle, followed by irradiation
4. Applications with MC2-01 vehicle, no irradiation
5. No application, but irradiation
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream
Baseline characteristics by cohort
| Measure |
Test Sites
n=58 Participants
5 test sites on the subject's back defined as:
1. Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
2. Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
3. Applications with MC2-01 vehicle, followed by irradiation
4. Applications with MC2-01 vehicle, no irradiation
5. No application, but irradiation
|
|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
I
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
II
|
18 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
III
|
38 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
IV
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
V
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
VI
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream, two sites with MC2-01 vehicle and one site untreated, followed by either irradiation or non-irradiation, all subjects received all 5 different treatments.
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.
Outcome measures
| Measure |
Test Sites
n=51 Participants
5 test sites on the subject's back defined as:
1. Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
2. Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
3. Applications with MC2-01 vehicle, followed by irradiation
4. Applications with MC2-01 vehicle, no irradiation
5. No application, but irradiation
|
|---|---|
|
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.
MC2-01 Cream, irradiation · No erythema/edema
|
48 Participants
|
|
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.
MC2-01 Cream, irradiation · Mild, definite erythema/edema
|
3 Participants
|
|
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.
MC2-01 Cream, irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 Cream, irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
MC2-01 Cream, No irradiation · No erythema/edema
|
49 Participants
|
|
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.
MC2-01 Cream, No irradiation · Mild, definite erythema/edema
|
2 Participants
|
|
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.
MC2-01 Cream, No irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 Cream, No irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
MC2-01 vehicle, irradiation · No erythema/edema
|
49 Participants
|
|
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.
MC2-01 vehicle, irradiation · Mild, definite erythema/edema
|
2 Participants
|
|
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.
MC2-01 vehicle, irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 vehicle, irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
MC2-01 vehicle, no irradiation · No erythema/edema
|
50 Participants
|
|
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.
MC2-01 vehicle, no irradiation · Mild, definite erythema/edema
|
1 Participants
|
|
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.
MC2-01 vehicle, no irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 vehicle, no irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
Control, Irradiation · No erythema/edema
|
47 Participants
|
|
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.
Control, Irradiation · Mild, definite erythema/edema
|
4 Participants
|
|
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.
Control, Irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
Control, Irradiation · Marked/severe erythema
|
0 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream, two sites with MC2-01 vehicle and one site untreated, followed by either irradiation or non-irradiation, all subjects received all 5 different treatments.
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.
Outcome measures
| Measure |
Test Sites
n=51 Participants
5 test sites on the subject's back defined as:
1. Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
2. Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
3. Applications with MC2-01 vehicle, followed by irradiation
4. Applications with MC2-01 vehicle, no irradiation
5. No application, but irradiation
|
|---|---|
|
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.
MC2-01 Cream, irradiation · No erythema/edema
|
48 Participants
|
|
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.
MC2-01 Cream, irradiation · Mild, definite erythema/edema
|
3 Participants
|
|
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.
MC2-01 Cream, irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 Cream, irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
MC2-01 Cream, No irradiation · No erythema/edema
|
51 Participants
|
|
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.
MC2-01 Cream, No irradiation · Mild, definite erythema/edema
|
0 Participants
|
|
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.
MC2-01 Cream, No irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 Cream, No irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
MC2-01 vehicle, irradiation · No erythema/edema
|
48 Participants
|
|
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.
MC2-01 vehicle, irradiation · Mild, definite erythema/edema
|
3 Participants
|
|
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.
MC2-01 vehicle, irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 vehicle, irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
MC2-01 vehicle, no irradiation · No erythema/edema
|
50 Participants
|
|
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.
MC2-01 vehicle, no irradiation · Mild, definite erythema/edema
|
1 Participants
|
|
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.
MC2-01 vehicle, no irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 vehicle, no irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
Control, Irradiation · No erythema/edema
|
48 Participants
|
|
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.
Control, Irradiation · Mild, definite erythema/edema
|
3 Participants
|
|
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.
Control, Irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
Control, Irradiation · Marked/severe erythema
|
0 Participants
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream, two sites with MC2-01 vehicle and one site untreated, followed by either irradiation or non-irradiation, all subjects received all 5 different treatments.
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.
Outcome measures
| Measure |
Test Sites
n=51 Participants
5 test sites on the subject's back defined as:
1. Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
2. Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
3. Applications with MC2-01 vehicle, followed by irradiation
4. Applications with MC2-01 vehicle, no irradiation
5. No application, but irradiation
|
|---|---|
|
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.
MC2-01 Cream, irradiation · No erythema/edema
|
51 Participants
|
|
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.
MC2-01 Cream, irradiation · Mild, definite erythema/edema
|
0 Participants
|
|
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.
MC2-01 Cream, irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 Cream, irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
MC2-01 Cream, No irradiation · No erythema/edema
|
51 Participants
|
|
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.
MC2-01 Cream, No irradiation · Mild, definite erythema/edema
|
0 Participants
|
|
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.
MC2-01 Cream, No irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 Cream, No irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
MC2-01 vehicle, irradiation · No erythema/edema
|
50 Participants
|
|
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.
MC2-01 vehicle, irradiation · Mild, definite erythema/edema
|
1 Participants
|
|
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.
MC2-01 vehicle, irradiation · Moderate erythema/defined edema
|
0 Participants
|
|
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.
MC2-01 vehicle, irradiation · Marked/severe erythema
|
0 Participants
|
|
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.
MC2-01 vehicle, no irradiation · No erythema/edema
|
51 Participants
|
|
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.
MC2-01 vehicle, no irradiation · Mild, definite erythema/edema
|
0 Participants
|
|
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.
MC2-01 vehicle, no irradiation · Moderate erythema/defined edema
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0 Participants
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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.
MC2-01 vehicle, no irradiation · Marked/severe erythema
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0 Participants
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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.
Control, Irradiation · No erythema/edema
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51 Participants
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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.
Control, Irradiation · Mild, definite erythema/edema
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0 Participants
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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.
Control, Irradiation · Moderate erythema/defined edema
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0 Participants
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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.
Control, Irradiation · Marked/severe erythema
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0 Participants
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Adverse Events
Test Sites
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place