search
Back to results

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

Primary Purpose

Phototoxicity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MC2-01 Cream, irradiation
MC2-01 Cream, no irradiation
MC2-01 vehicle, irradiation
MC2-01 vehicle, no irradiation
Control, irradiation
Sponsored by
MC2 Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phototoxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • TKL Research Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

MC2-01 Cream, irradiation

MC2-01 Cream, no irradiation

MC2-01 vehicle, irradiation

MC2-01 vehicle, no irradiation

Control, irradiation

Arm Description

One applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation

One 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, edema and other signs of cutaneous irritation

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

One application 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

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
March 20, 2019
Last Updated
February 11, 2020
Sponsor
MC2 Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT03892564
Brief Title
Evaluation of Potential Phototoxicity Skin Reaction After Use of MC2-01 Cream
Official Title
A 4-Day, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce a Phototoxicity Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
March 9, 2019 (Actual)
Study Completion Date
March 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MC2 Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phototoxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MC2-01 Cream, irradiation
Arm Type
Experimental
Arm Description
One applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation
Arm Title
MC2-01 Cream, no irradiation
Arm Type
Experimental
Arm Description
One 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, edema and other signs of cutaneous irritation
Arm Title
MC2-01 vehicle, irradiation
Arm Type
Experimental
Arm Description
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
Arm Title
MC2-01 vehicle, no irradiation
Arm Type
Experimental
Arm Description
One application 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
Arm Title
Control, irradiation
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
MC2-01 Cream, irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
MC2-01 Cream, no irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
MC2-01 vehicle, irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
MC2-01 vehicle, no irradiation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Control, irradiation
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S Dorsik
Organizational Affiliation
TKL Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
TKL Research Inc
City
Fair Lawn
State/Province
New Jersey
ZIP/Postal Code
07410
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Single site study

Learn more about this trial

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

We'll reach out to this number within 24 hrs