CompletedNCT03892564Updated Feb 12, 2020Results posted

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

A Phase 1 interventional study of MC2-01 Cream, irradiation and MC2-01 Cream, no irradiation in Phototoxicity, sponsored by MC2 Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-12.

Sponsored by MC2 Therapeutics · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 35
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Phototoxicity

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Dermatitis, Phototoxic 22

In context

Dermatitis, Phototoxic

22 studies on the registry are indexed under Dermatitis, Phototoxic; 1 is open to participants now.

This study's enrollment of 35 is close to the median of 35 across 19 interventional studies indexed under Dermatitis, Phototoxic.

Browse Dermatitis, Phototoxic studies →

Lead sponsor

MC2 Therapeutics is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 35 participants (actual)

Study arms

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
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
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
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
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

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

What researchers measure

Primary outcomes

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
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
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

Results

Posted Feb 12, 2020

Participant flow

First Subject First Visit: 27-Feb-2019. Last Subject Last Visit: 09-Mar-2019

Participant flow — Overall Study
Milestone	Test Sites
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
Withdrew: Withdrawal by subject	2

Outcome measures

PrimaryWithin-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
Reported as:: Count of participants · Participants

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
Participants	Test Sites
MC2-01 Cream, irradiation — No erythema/edema	33
MC2-01 Cream, irradiation — Mild, definite erythema/edema	0
MC2-01 Cream, non-irradiation — No erythema/edema	33
MC2-01 Cream, non-irradiation — Mild, definite erythema/edema	0
MC2-01 vehicle, irradiation — No erythema/edema	32
MC2-01 vehicle, irradiation — Mild, definite erythema/edema	1
MC2-01 vehicle, non-irradiation — No erythema/edema	32
MC2-01 vehicle, non-irradiation — Mild, definite erythema/edema	1
Control site — No erythema/edema	33
Control site — Mild, definite erythema/edema	0

Time frame:: 24h post-irradiation
Reported as:: Count of participants · Participants

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
Participants	Test Sites
MC2-01 Cream, irradiation — No erythema/edema	21
MC2-01 Cream, irradiation — Mild, definite erythema/edema	12
MC2-01 Cream, non-irradiation — No erythema/edema	33
MC2-01 Cream, non-irradiation — Mild, definite erythema/edema	0
MC2-01 vehicle, irradiation — No erythema/edema	21
MC2-01 vehicle, irradiation — Mild, definite erythema/edema	12
MC2-01 vehicle, non-irradiation — No erythema/edema	33
MC2-01 vehicle, non-irradiation — Mild, definite erythema/edema	0
Control site — No erythema/edema	21
Control site — Mild, definite erythema/edema	12

Time frame:: 48h post-irradiation
Reported as:: Count of participants · Participants

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
Participants	Test Sites
MC2-01 Cream, irradiation — No erythema/edema	25
MC2-01 Cream, irradiation — Mild, definite erythema/edema	8
MC2-01 Cream, non-irradiation — No erythema/edema	33
MC2-01 Cream, non-irradiation — Mild, definite erythema/edema	0
MC2-01 vehicle, irradiation — No erythema/edema	25
MC2-01 vehicle, irradiation — Mild, definite erythema/edema	8
MC2-01 vehicle, non-irradiation — No erythema/edema	33
MC2-01 vehicle, non-irradiation — Mild, definite erythema/edema	0
Control site — No erythema/edema	25
Control site — Mild, definite erythema/edema	8

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MC2-01 Cream, Irradiation	0/35 (0%)	0/35 (0%)	0/35 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Test Sites
Mean	55.0 ± 9.65

Sex: Female, Male
Sex: Female, Male(Participants)	Test Sites
Female	31
Male	4

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Test Sites
Hispanic or Latino	6
Not Hispanic or Latino	29
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Test Sites
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	34
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Test Sites
United States	35

Fitzpatrick Skin Type
Fitzpatrick Skin Type(Participants)	Test Sites
II	9
III	26

Study locations

1 site

TKL Research Inc
Fair Lawn, New Jersey 07410, United States

References and documents

Study documents

Study protocol · Jan 10, 2019
Statistical analysis plan · Mar 11, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Single site study

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03892564
Lead sponsor: MC2 Therapeutics
Responsible party: Sponsor
First posted: Mar 27, 2019
Start date: Feb 27, 2019
Primary completion: Mar 9, 2019
Completion: Mar 9, 2019
Results posted: Feb 12, 2020
Last update: Feb 12, 2020

Study contacts

Jonathan S Dorsik

principal investigator · TKL Research, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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