Phase 1
N=58
Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream
Photoallergy
Bottom Line
View on ClinicalTrials.gov: NCT03899064 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: 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. — 48; 3; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Induction: Application of MC2-01 Cream, irradiation (Drug); Induction: Application of MC2-01 Cream, no irradiation (Drug); Induction: Applications of MC2-01 vehicle, irradiation (Drug); Induction: Applications of MC2-01 vehicle, no irradiation (Drug); Challenge: Application of MC2-01 Cream, irradiation (Drug); Challenge: Application of MC2-01 Cream, no irradiation (Drug); Challenge: Applications of MC2-01 vehicle, irradiation (Drug); Challenge: Applications of MC2-01 vehicle, no irradiation (Drug); Challenge: Control, irradiation (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MC2 Therapeutics
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
51; 0; 0; 0; 51; 0 | — |
| PRIMARY 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. |
51; 0; 0; 0; 51; 0 | — |
| PRIMARY 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. |
51; 0; 0; 0; 51; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03899064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.