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

• Sponsor: MC2 Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03892564
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 5
• Actual Duration (Days): 10
• Patients Per Site Per Month: 106.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Phototoxicity	Drug: MC2-01 Cream, irradiation; Drug: MC2-01 Cream, no irradiation; Drug: MC2-01 vehicle, irradiation; Drug: MC2-01 vehicle, no irradiation; Drug: Control, irradiation	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 modelOne 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: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 27, 2019
• Actual Primary Completion Date: Mar 9, 2019
• Actual Study Completion Date: Mar 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MC2-01 Cream, irradiation One applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation	Drug: MC2-01 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
Experimental: MC2-01 Cream, no 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	Drug: MC2-01 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
Experimental: MC2-01 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	Drug: MC2-01 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
Experimental: MC2-01 vehicle, no irradiation 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	Drug: MC2-01 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
Experimental: Control, 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	Drug: Control, 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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 [24h post-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

3. 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 [48h post-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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TKL Research Inc	Fair Lawn	New Jersey	United States	07410

Sponsors and Collaborators

• MC2 Therapeutics

Investigators

• Principal Investigator: Jonathan S Dorsik, TKL Research, Inc.

Study Documents (Full-Text)

• Study Protocol - Jan 10, 2019
• Statistical Analysis Plan - Mar 11, 2019

More Information

Publications

None provided.

• Responsible Party: MC2 Therapeutics
• ClinicalTrials.gov Identifier: NCT03892564
• Other Study ID Numbers: MC2-01-C9
• First Posted: Mar 27, 2019
• Last Update Posted: Feb 12, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Phototoxic

Study Results

Participant Flow

Recruitment Details	First Subject First Visit: 27-Feb-2019. Last Subject Last Visit: 09-Mar-2019
Pre-assignment Detail	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.

Arm/Group Title	Test Sites
Arm/Group Description	5 test sites on the subject's back defined as: - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - Control site (no application, only irradiated) to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation
Period Title: Overall Study
STARTED	35
MC2-01 Cream + Irridiation	35
MC2-01 Cream + Non-irridiation	35
MC2-01 Vehicle + Irridiation	35
MC2-01 Vehicle + Non-irridiation	35
Control Site	35
COMPLETED	33
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Test Sites
Arm/Group Description	5 test sites on the subject's back defined as: - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - Control site (no application, only irradiated) to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation
Overall Participants	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.0 (9.65)
Sex: Female, Male (Count of Participants)
Female	31 88.6%
Male	4 11.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 17.1%
Not Hispanic or Latino	29 82.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	34 97.1%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	35 100%
Fitzpatrick Skin Type (Count of Participants)
II	9 25.7%
III	26 74.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Test Sites
Arm/Group Description	- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - control, irradiated
Measure Participants	33
No erythema/edema	33 94.3%
Mild, definite erythema/edema	0 0%
No erythema/edema	33 94.3%
Mild, definite erythema/edema	0 0%
No erythema/edema	32 91.4%
Mild, definite erythema/edema	1 2.9%
No erythema/edema	32 91.4%
Mild, definite erythema/edema	1 2.9%
No erythema/edema	33 94.3%
Mild, definite erythema/edema	0 0%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Test Sites
Arm/Group Description	5 test sites on the subject's back defined as: - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - control, irradiated to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation
Measure Participants	33
No erythema/edema	21 60%
Mild, definite erythema/edema	12 34.3%
No erythema/edema	33 94.3%
Mild, definite erythema/edema	0 0%
No erythema/edema	21 60%
Mild, definite erythema/edema	12 34.3%
No erythema/edema	33 94.3%
Mild, definite erythema/edema	0 0%
No erythema/edema	21 60%
Mild, definite erythema/edema	12 34.3%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Test Sites
Arm/Group Description	5 test sites on the subject's back defined as: - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - control, irradiated to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation
Measure Participants	33
No erythema/edema	25 71.4%
Mild, definite erythema/edema	8 22.9%
No erythema/edema	33 94.3%
Mild, definite erythema/edema	0 0%
No erythema/edema	25 71.4%
Mild, definite erythema/edema	8 22.9%
No erythema/edema	33 94.3%
Mild, definite erythema/edema	0 0%
No erythema/edema	25 71.4%
Mild, definite erythema/edema	8 22.9%

Adverse Events

Time Frame	AEs were collected/assessed from the time of the informed consent form was signed by the subject at the screening visit and during the test phase, which consisted of in total of 4 days. the 4th day was considered the last visit for the subjects. AEs assessed as reasonably possibly related to the trial medication had to be followed until they were resolved or until the medical condition of the subject was stable.
Adverse Event Reporting Description	35 patients participated in the study and all patients received all 5 types of treatments. Therefore data for the 'All-Cause Mortality', 'Serious Adverse Events' and 'Other Adverse Events' fields are included and assessed for all types of medication.
Arm/Group Title	MC2-01 Cream, Irradiation
Arm/Group Description	5 test sites on the subject's back defined as: - One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation - One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation - One application of MC2-01 vehicle, followed by irradiation. - One application of MC2-01 vehicle, non-irradiation. - control, irradiated
All Cause Mortality
	MC2-01 Cream, Irradiation
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Serious Adverse Events
	MC2-01 Cream, Irradiation
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Other (Not Including Serious) Adverse Events
	MC2-01 Cream, Irradiation
	Affected / at Risk (%)	# Events
Total	0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.