Phototoxicity
Conditions
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.
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.
Interventions
DRUGMC2-01 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
DRUGMC2-01 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
DRUGMC2-01 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
DRUGMC2-01 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
DRUGControl, 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
Sponsors
MC2 Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
One treatment with MC2-01 Cream, MC2-01 vehicle and control on defined applications site (N=5), followed by irradiation/non-irradiation and evaluation 24 or 48 hours post irradiation, within subject comparison model
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
First Subject First Visit: 27-Feb-2019. Last Subject Last Visit: 09-Mar-2019
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Test Sites 5 test sites on the subject's back defined as:
1. \- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation
2. \- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation
3. \- One application of MC2-01 vehicle, followed by irradiation.
4. \- One application of MC2-01 vehicle, non-irradiation.
5. \- Control site (no application, only irradiated)
to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Test Sites |
|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 9.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type II | 9 Participants |
| Fitzpatrick Skin Type III | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
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
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Test Sites | 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 | MC2-01 Cream, irradiation | No erythema/edema | 33 Participants |
| Test Sites | 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 | MC2-01 Cream, irradiation | Mild, definite erythema/edema | 0 Participants |
| Test Sites | 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 | MC2-01 Cream, non-irradiation | No erythema/edema | 33 Participants |
| Test Sites | 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 | MC2-01 Cream, non-irradiation | Mild, definite erythema/edema | 0 Participants |
| Test Sites | 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 | MC2-01 vehicle, irradiation | No erythema/edema | 32 Participants |
| Test Sites | 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 | MC2-01 vehicle, irradiation | Mild, definite erythema/edema | 1 Participants |
| Test Sites | 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 | MC2-01 vehicle, non-irradiation | No erythema/edema | 32 Participants |
| Test Sites | 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 | MC2-01 vehicle, non-irradiation | Mild, definite erythema/edema | 1 Participants |
| Test Sites | 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 | Control site | No erythema/edema | 33 Participants |
| Test Sites | 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 | Control site | Mild, definite erythema/edema | 0 Participants |
Primary
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
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Test Sites | 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 | MC2-01 Cream, irradiation | No erythema/edema | 21 Participants |
| Test Sites | 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 | MC2-01 Cream, irradiation | Mild, definite erythema/edema | 12 Participants |
| Test Sites | 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 | MC2-01 Cream, non-irradiation | No erythema/edema | 33 Participants |
| Test Sites | 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 | MC2-01 Cream, non-irradiation | Mild, definite erythema/edema | 0 Participants |
| Test Sites | 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 | MC2-01 vehicle, irradiation | No erythema/edema | 21 Participants |
| Test Sites | 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 | MC2-01 vehicle, irradiation | Mild, definite erythema/edema | 12 Participants |
| Test Sites | 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 | MC2-01 vehicle, non-irradiation | No erythema/edema | 33 Participants |
| Test Sites | 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 | MC2-01 vehicle, non-irradiation | Mild, definite erythema/edema | 0 Participants |
| Test Sites | 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 | Control site | No erythema/edema | 21 Participants |
| Test Sites | 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 | Control site | Mild, definite erythema/edema | 12 Participants |
Primary
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
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
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Test Sites | 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 | MC2-01 Cream, irradiation | No erythema/edema | 25 Participants |
| Test Sites | 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 | MC2-01 Cream, irradiation | Mild, definite erythema/edema | 8 Participants |
| Test Sites | 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 | MC2-01 Cream, non-irradiation | No erythema/edema | 33 Participants |
| Test Sites | 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 | MC2-01 Cream, non-irradiation | Mild, definite erythema/edema | 0 Participants |
| Test Sites | 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 | MC2-01 vehicle, irradiation | No erythema/edema | 25 Participants |
| Test Sites | 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 | MC2-01 vehicle, irradiation | Mild, definite erythema/edema | 8 Participants |
| Test Sites | 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 | MC2-01 vehicle, non-irradiation | No erythema/edema | 33 Participants |
| Test Sites | 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 | MC2-01 vehicle, non-irradiation | Mild, definite erythema/edema | 0 Participants |
| Test Sites | 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 | Control site | No erythema/edema | 25 Participants |
| Test Sites | 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 | Control site | Mild, definite erythema/edema | 8 Participants |