Trial Outcomes & Findings for Evaluation of Potential Phototoxicity Skin Reaction After Use of MC2-01 Cream (NCT NCT03892564)

Last Updated: 2020-02-12

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

Baseline, before irradiation

Results posted on

2020-02-12

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	Test Sites 5 test sites on the subject's back defined as: 1. \- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation 2. \- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation 3. \- One application of MC2-01 vehicle, followed by irradiation. 4. \- One application of MC2-01 vehicle, non-irradiation. 5. \- Control site (no application, only irradiated) to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation
Overall Study STARTED	35
Overall Study MC2-01 Cream + Irridiation	35
Overall Study MC2-01 Cream + Non-irridiation	35
Overall Study MC2-01 Vehicle + Irridiation	35
Overall Study MC2-01 Vehicle + Non-irridiation	35
Overall Study Control Site	35
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Sites 5 test sites on the subject's back defined as: 1. \- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation 2. \- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation 3. \- One application of MC2-01 vehicle, followed by irradiation. 4. \- One application of MC2-01 vehicle, non-irradiation. 5. \- Control site (no application, only irradiated) to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Sites n=35 Participants 5 test sites on the subject's back defined as: 1. \- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation 2. \- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation 3. \- One application of MC2-01 vehicle, followed by irradiation. 4. \- One application of MC2-01 vehicle, non-irradiation. 5. \- Control site (no application, only irradiated) to perform visual evaluation of application site of erythema, edema and other signs of cutaneous irritation
Age, Continuous	55.0 years STANDARD_DEVIATION 9.65 • n=99 Participants
Sex: Female, Male Female	31 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	34 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	35 participants n=99 Participants
Fitzpatrick Skin Type II	9 Participants n=99 Participants
Fitzpatrick Skin Type III	26 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, before irradiation

Population: 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.

Outcome measures

Outcome measures
Measure	Test Sites n=33 Participants 1. \- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation 2. \- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation 3. \- One application of MC2-01 vehicle, followed by irradiation. 4. \- One application of MC2-01 vehicle, non-irradiation. 5. \- control, irradiated
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 vehicle, irradiation · Mild, definite erythema/edema	1 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 MC2-01 vehicle, non-irradiation · No erythema/edema	32 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 MC2-01 vehicle, non-irradiation · Mild, definite erythema/edema	1 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 Control site · No erythema/edema	33 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 Control site · Mild, definite erythema/edema	0 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 MC2-01 Cream, irradiation · Mild, definite erythema/edema	0 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 MC2-01 Cream, non-irradiation · No erythema/edema	33 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 MC2-01 vehicle, irradiation · No erythema/edema	32 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 MC2-01 Cream, non-irradiation · Mild, definite erythema/edema	0 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 MC2-01 Cream, irradiation · No erythema/edema	33 Participants

PRIMARY outcome

Timeframe: 24h post-irradiation

Outcome measures

Outcome measures
Measure	Test Sites n=33 Participants 1. \- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation 2. \- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation 3. \- One application of MC2-01 vehicle, followed by irradiation. 4. \- One application of MC2-01 vehicle, non-irradiation. 5. \- control, irradiated
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, irradiation · No erythema/edema	21 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 MC2-01 Cream, irradiation · Mild, definite erythema/edema	12 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 MC2-01 Cream, non-irradiation · No erythema/edema	33 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 MC2-01 Cream, non-irradiation · Mild, definite erythema/edema	0 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 MC2-01 vehicle, irradiation · No erythema/edema	21 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 MC2-01 vehicle, irradiation · Mild, definite erythema/edema	12 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 MC2-01 vehicle, non-irradiation · No erythema/edema	33 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 MC2-01 vehicle, non-irradiation · Mild, definite erythema/edema	0 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 Control site · No erythema/edema	21 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 Control site · Mild, definite erythema/edema	12 Participants

PRIMARY outcome

Timeframe: 48h post-irradiation

Outcome measures

Outcome measures
Measure	Test Sites n=33 Participants 1. \- One application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation 2. \- One application with MC2-01 Cream Calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, non-irradiation 3. \- One application of MC2-01 vehicle, followed by irradiation. 4. \- One application of MC2-01 vehicle, non-irradiation. 5. \- control, irradiated
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, irradiation · No erythema/edema	25 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 MC2-01 Cream, irradiation · Mild, definite erythema/edema	8 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 MC2-01 Cream, non-irradiation · No erythema/edema	33 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 MC2-01 Cream, non-irradiation · Mild, definite erythema/edema	0 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 MC2-01 vehicle, irradiation · No erythema/edema	25 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 MC2-01 vehicle, irradiation · Mild, definite erythema/edema	8 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 MC2-01 vehicle, non-irradiation · No erythema/edema	33 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 MC2-01 vehicle, non-irradiation · Mild, definite erythema/edema	0 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 Control site · No erythema/edema	25 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 Control site · Mild, definite erythema/edema	8 Participants

Adverse Events

MC2-01 Cream, Irradiation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Birgitte Vestbjerg

MC2 Therapeutics

Phone: +45 2077 2575

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place