Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream

NCT03899064 | Completed Phase 1 Results FDA Drug

• 1 other identifier: MC2-01-C10
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a 6-week, Randomized study evaluating the potential of MC2-01 Cream to induce a photoallergic skin reaction in Healthy subjects, using a controlled photopatch test design.

Conditions

Photoallergy

Outcome Measures

Primary Outcomes (3)

• Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.

  After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated. MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another naive test site was untreated. 24 hours after product application, one of each test site (MC2-01 Cream, MC2-01 vehicle) + the untreated site were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 5 test sites 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study. The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.

  24 hours

• Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.

  After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated. MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another two naive test sites were untreated. 24 hours of product application, one of each test site (MC2-01 Cream, MC2-01 vehicle and untreated) were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 6 test sites, 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study. The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.

  48 hours

• Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.

  After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated. MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another two naive test sites were untreated. 24 hours of product application, one of each test site (MC2-01 Cream, MC2-01 vehicle and untreated) were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 6 test sites, 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study. The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.

  72 hours

Study Arms (9)

Induction:MC2-01 Cream, irradiation

EXPERIMENTAL

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

Drug: Induction: Application of MC2-01 Cream, irradiation

Induction: MC2-01 Cream, no irradiation

EXPERIMENTAL

Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation

Drug: Induction: Application of MC2-01 Cream, no irradiation

Induction: MC2-01 vehicle, irradiation

EXPERIMENTAL

Applications with MC2-01 vehicle, followed by irradiation

Drug: Induction: Applications of MC2-01 vehicle, irradiation

Induction: MC2-01 vehicle, no irradiation

EXPERIMENTAL

Applications with MC2-01 vehicle, no irradiation

Drug: Induction: Applications of MC2-01 vehicle, no irradiation

Challenge: MC2-01 Cream, irradiation

EXPERIMENTAL

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

Drug: Challenge: Application of MC2-01 Cream, irradiation

Challenge: MC2-01 Cream, No irradiation

EXPERIMENTAL

Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation

Drug: Challenge: Application of MC2-01 Cream, no irradiation

Challenge: MC2-01 vehicle, irradiation

EXPERIMENTAL

Application with MC2-01 vehicle, followed by irradiation

Drug: Challenge: Applications of MC2-01 vehicle, irradiation

Challenge: MC2-01 vehicle, no irradiation

EXPERIMENTAL

Application with MC2-01 vehicle, no irradiation

Drug: Challenge: Applications of MC2-01 vehicle, no irradiation

Challenge: Control, irradiation

EXPERIMENTAL

No application, but irradiation

Drug: Challenge: Control, irradiation

Interventions

Induction: Application of MC2-01 Cream, irradiation DRUG

Repeated applications of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), 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

Induction:MC2-01 Cream, irradiation

Induction: Application of MC2-01 Cream, no irradiation DRUG

Repeated applications 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

Induction: MC2-01 Cream, no irradiation

Induction: Applications of MC2-01 vehicle, irradiation DRUG

Repeated applications 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

Induction: MC2-01 vehicle, irradiation

Induction: Applications of MC2-01 vehicle, no irradiation DRUG

Repeated applications 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

Induction: MC2-01 vehicle, no irradiation

Challenge: Application of MC2-01 Cream, irradiation DRUG

Single application of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema

Challenge: MC2-01 Cream, irradiation

Challenge: Application of MC2-01 Cream, no irradiation DRUG

Single 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 and edema

Challenge: MC2-01 Cream, No irradiation

Challenge: Applications of MC2-01 vehicle, irradiation DRUG

Single application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema

Challenge: MC2-01 vehicle, irradiation

Challenge: Applications of MC2-01 vehicle, no irradiation DRUG

Single application of MC2-01 vehicle, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema

Challenge: MC2-01 vehicle, no irradiation

Challenge: Control, irradiation DRUG

No application, but irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema

Challenge: Control, irradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MC2 Therapeutics: lead

Study Sites (1)

TKL Research Inc.

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Dermatitis, Photoallergic

Interventions

Radiation

Condition Hierarchy (Ancestors)

Dermatitis, Allergic Contact; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Photosensitivity Disorders; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

• Title: Birgitte Vestbjerg
• Organization: MC2 Therapeutics

bve@mc2therapeutics.com

+44 2077 2575

Study Officials

• Jonathan S Dosik, MD

  TKL Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The tests sites (M2-01 Cream, MC2-01 vehicle, control) will not be blinded to the site staff involved in the preparation/application and removal of treatments. The subjects and the trained assessor will be blinded to the IPs and treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consist of an Induction phase, where treatments (MC2-01 Cream, MC2-01 vehicle) were applied to 2 test sites each (n=4), followed by irradiation/non-irradiation and evaluation 24, 48 or 72 hours post-irradiation. This was repeated in total 6 times over an 3 weeks period. The induction phase was followed by a challenge phase, where treatments (MC2-01 Cream, MC2-01 vehicle) were applied to each two naive test sites and another naive test site was untreated. 24 hours of product application, one of each test sites (MC2-01 Cream, MC2-01 vehicle) + the untreated test site were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 5 test sites, 24, 48 and 72 hours post-irradiation.

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: April 2, 2019
• Study Start: February 13, 2019
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: March 11, 2020
• Results First Posted: March 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)