Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 1 N=35 Randomized Double-blind Treatment

Evaluation of Potential Phototoxicity Skin Reaction After Use of MC2-01 Cream

Phototoxicity

Bottom Line

View on ClinicalTrials.gov: NCT03892564 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: 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 — 33; 0; 33; 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
MC2-01 Cream, irradiation (Drug); MC2-01 Cream, no irradiation (Drug); MC2-01 vehicle, irradiation (Drug); MC2-01 vehicle, no irradiation (Drug); Control, irradiation (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
MC2 Therapeutics
Primary completion
Mar 2019

Outcome Measures

OutcomeResultp-value
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		 25; 8; 33; 0; 25; 8 —
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		 25; 8; 33; 0; 25; 8 —
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		 25; 8; 33; 0; 25; 8 —

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.

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03892564). 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.

Back to search