Photoallergy Clinical Trial
Official title:
A 6-Week, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce Photoallergic Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design
| Verified date | February 2020 |
| Source | MC2 Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | April 5, 2019 |
| Est. primary completion date | April 5, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 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 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | TKL Research Inc. | Fair Lawn | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| MC2 Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03812887 -
Photopatch Test Study (POST Study)
|
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| Completed |
NCT02872220 -
To Test for Photo Allergy Reaction of Sunscreens
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N/A |