A Phase 1 interventional study of Induction: Application of MC2-01 Cream, irradiation and Induction: Application of MC2-01 Cream, no irradiation in Photoallergy, sponsored by MC2 Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-11.
Sponsored by MC2 Therapeutics · Phase 1, Interventional, and Treatment
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.
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.
MC2 Therapeutics is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
Drug: Induction: Application of MC2-01 Cream, irradiation
Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
Drug: Induction: Application of MC2-01 Cream, no irradiation
Applications with MC2-01 vehicle, followed by irradiation
Drug: Induction: Applications of MC2-01 vehicle, irradiation
Applications with MC2-01 vehicle, no irradiation
Drug: Induction: Applications of MC2-01 vehicle, no irradiation
Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
Drug: Challenge: Application of MC2-01 Cream, irradiation
Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation
Drug: Challenge: Application of MC2-01 Cream, no irradiation
Application with MC2-01 vehicle, followed by irradiation
Drug: Challenge: Applications of MC2-01 vehicle, irradiation
Application with MC2-01 vehicle, no irradiation
Drug: Challenge: Applications of MC2-01 vehicle, no irradiation
No application, but irradiation
Drug: Challenge: Control, irradiation
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
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
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
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
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
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
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
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
No application, but irradiation. Visual evaluation of application site using a visual scale that rated the degree of 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 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
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.
Time frame: 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.
Time frame: 72 hours
First Subject First Visit: 18-Feb-2019; Last Subject Last Visit: 05-Apr-2019
| Milestone | Test Sites |
|---|---|
| Started | 58 |
| Mc2-01 cream, irradiation | 58 |
| Mc2-01 cream, no irradiation | 58 |
| Mc2-01 vehicle, irradiation | 58 |
| Mc2-01 vehicle, no irradiation | 58 |
| Control, irradiation | 58 |
| Completed | 51 |
| Not completed | 7 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Other | 2 |
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.
| Participants | Test Sites |
|---|---|
| MC2-01 Cream, irradiation — No erythema/edema | 48 |
| MC2-01 Cream, irradiation — Mild, definite erythema/edema | 3 |
| MC2-01 Cream, irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 Cream, irradiation — Marked/severe erythema | 0 |
| MC2-01 Cream, No irradiation — No erythema/edema | 49 |
| MC2-01 Cream, No irradiation — Mild, definite erythema/edema | 2 |
| MC2-01 Cream, No irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 Cream, No irradiation — Marked/severe erythema | 0 |
| MC2-01 vehicle, irradiation — No erythema/edema | 49 |
| MC2-01 vehicle, irradiation — Mild, definite erythema/edema | 2 |
| MC2-01 vehicle, irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 vehicle, irradiation — Marked/severe erythema | 0 |
| MC2-01 vehicle, no irradiation — No erythema/edema | 50 |
| MC2-01 vehicle, no irradiation — Mild, definite erythema/edema | 1 |
| MC2-01 vehicle, no irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 vehicle, no irradiation — Marked/severe erythema | 0 |
| Control, Irradiation — No erythema/edema | 47 |
| Control, Irradiation — Mild, definite erythema/edema | 4 |
| Control, Irradiation — Moderate erythema/defined edema | 0 |
| Control, Irradiation — Marked/severe erythema | 0 |
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.
| Participants | Test Sites |
|---|---|
| MC2-01 Cream, irradiation — No erythema/edema | 48 |
| MC2-01 Cream, irradiation — Mild, definite erythema/edema | 3 |
| MC2-01 Cream, irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 Cream, irradiation — Marked/severe erythema | 0 |
| MC2-01 Cream, No irradiation — No erythema/edema | 51 |
| MC2-01 Cream, No irradiation — Mild, definite erythema/edema | 0 |
| MC2-01 Cream, No irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 Cream, No irradiation — Marked/severe erythema | 0 |
| MC2-01 vehicle, irradiation — No erythema/edema | 48 |
| MC2-01 vehicle, irradiation — Mild, definite erythema/edema | 3 |
| MC2-01 vehicle, irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 vehicle, irradiation — Marked/severe erythema | 0 |
| MC2-01 vehicle, no irradiation — No erythema/edema | 50 |
| MC2-01 vehicle, no irradiation — Mild, definite erythema/edema | 1 |
| MC2-01 vehicle, no irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 vehicle, no irradiation — Marked/severe erythema | 0 |
| Control, Irradiation — No erythema/edema | 48 |
| Control, Irradiation — Mild, definite erythema/edema | 3 |
| Control, Irradiation — Moderate erythema/defined edema | 0 |
| Control, Irradiation — Marked/severe erythema | 0 |
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.
| Participants | Test Sites |
|---|---|
| MC2-01 Cream, irradiation — No erythema/edema | 51 |
| MC2-01 Cream, irradiation — Mild, definite erythema/edema | 0 |
| MC2-01 Cream, irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 Cream, irradiation — Marked/severe erythema | 0 |
| MC2-01 Cream, No irradiation — No erythema/edema | 51 |
| MC2-01 Cream, No irradiation — Mild, definite erythema/edema | 0 |
| MC2-01 Cream, No irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 Cream, No irradiation — Marked/severe erythema | 0 |
| MC2-01 vehicle, irradiation — No erythema/edema | 50 |
| MC2-01 vehicle, irradiation — Mild, definite erythema/edema | 1 |
| MC2-01 vehicle, irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 vehicle, irradiation — Marked/severe erythema | 0 |
| MC2-01 vehicle, no irradiation — No erythema/edema | 51 |
| MC2-01 vehicle, no irradiation — Mild, definite erythema/edema | 0 |
| MC2-01 vehicle, no irradiation — Moderate erythema/defined edema | 0 |
| MC2-01 vehicle, no irradiation — Marked/severe erythema | 0 |
| Control, Irradiation — No erythema/edema | 51 |
| Control, Irradiation — Mild, definite erythema/edema | 0 |
| Control, Irradiation — Moderate erythema/defined edema | 0 |
| Control, Irradiation — Marked/severe erythema | 0 |
Collected over AEs were collected/assessed from the time of the informed consent was signed by the subject at the screening visit and during both the induction phase, which consisted of 3 weeks, and the challenge phase, which consisted of 4 days. The 4th day in the challenge phase was considered the last visit for the subjects. AEs assessed as reasonably possibly related to the treatment had to be followed until they were resolved or until the medical condition of the subject was stable.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Sites | 0/58 (0%) | 0/58 (0%) | 0/58 (0%) |
| Age, Continuous(years) | Test Sites |
|---|---|
| Mean | 57.8 ± 11.20 |
| Sex: Female, Male(Participants) | Test Sites |
|---|---|
| Female | 46 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Test Sites |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 47 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Test Sites |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 56 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Test Sites |
|---|---|
| United States | 58 |
| Fitzpatrick Skin Type(Participants) | Test Sites |
|---|---|
| I | 2 |
| II | 18 |
| III | 38 |
| IV | 0 |
| V | 0 |
| VI | 0 |
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Plan to share: No — Single site study
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Dermatitis, Photoallergic
MC2 Therapeutics