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A Study to Determine the Safety and Sensitizing Potential of HAT1 Topical Products Using Skin Sensitivity Patch Tests

Primary Purpose

Healthy, Atopic Dermatitis, Psoriasis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
HAT1
Saline Solution
Sponsored by
Haus Bioceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

The study population in this report comprises of healthy normal subjects, patients with active plaque psoriasis, and patients with atopic dermatitis.

Inclusion Criteria:

  • Males or females 18 years of age or older - no more than 20% of the panel should be comprised of subjects over the age of 65.
  • In general good health as determined by the Medical and Dermatological History Questionnaire, or as having diagnosed with atopic dermatitis confirmed by the investigating dermatologist, or as having diagnosed with active plaque psoriasis confirmed by the investigating dermatologist.
  • Able to read, understand and sign an informed consent agreement after being advised of the nature of the study.
  • Willing to refrain from using lotions, creams, powders or other skin preparations on the skin in the test area for the duration of the study.
  • Willing to refrain from exposing skin sites to the sun or going to tanning beds for the duration of the study.

Exclusion Criteria:

  • Have a clinical diagnosis of a dermatological condition other that atopic dermatitis or psoriasis (such as contact dermatitis, cutaneous lymphoma, tinea corpori's, etc.), or have non plaque forms of psoriasis (for example, erythrodermic, guttate, or pustular), or have bacterial infections of the skin, including impetigo or abscesses.
  • Have a history of skin cancer or have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months.
  • Have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk.
  • Have pigmentation, extensive scarring, or pigmented lesions in the patch areas, which could interfere with the scoring.
  • Have had a mastectomy or axillary lymph nodes removed.
  • Have an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.).
  • Are currently taking any immunosuppressant medication 8. Have insulin-dependent diabetes.
  • Have asthma or any other chronic respiratory condition requiring daily therapy
  • Are currently using on a routine or frequent basis antihistamines or any systemic or topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.). Maximum acceptable dosage should be determined by written laboratory guidelines.
  • Have used a topical anti-inflammatory in the patch area within the last 2 weeks
  • Are currently receiving allergy injections, expects to start injections before the conclusion of the study or has had the final injection within a week of the study start
  • Are currently participating in another dermal study of any kind
  • Are currently participating in any clinical study, which in the judgment of the Investigator or Designate, could potentially affect responses in either study.
  • Have a confirmed skin allergy as a result of participation in a patch study.
  • Have a known sensitivity or allergy relating to the substance(s) being evaluated.
  • Have a known sensitivity or allergy to adhesives, surgical tapes, bandages, etc.
  • Have scars, moles, sunburn, tattoos, etc. in the patch area.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    HAT1-EPBF2

    HAT1-HMF3

    Saline Solution: Sodium Chloride

    Arm Description

    CIT was conducted over a period of approximately 15 days for each subject to determine the irritation and/or sensitization potential of a test material(s) under occlusion by 14 repeated closed occlusive patch application every 24 hrs. A final grade was taken 24 hours following the last patch application. PT was conducted over a period of approximately 6 days for each subject to determine the phototoxicity of the test product. HRIPT was conducted over a period of approximately 6-8 weeks for each subject to confirm that the test substances will not produce evidence of delayed contact sensitization following external contact with the skin by means of a repeated patch application procedure.

    CIT was conducted over a period of approximately 15 days for each subject to determine the irritation and/or sensitization potential of a test material(s) under occlusion by 14 repeated closed occlusive patch application every 24 hrs. A final grade was taken 24 hours following the last patch application. PT was conducted over a period of approximately 6 days for each subject to determine the phototoxicity of the test product. HRIPT was conducted over a period of approximately 6-8 weeks for each subject to confirm that the test substances will not produce evidence of delayed contact sensitization following external contact with the skin by means of a repeated patch application procedure.

    Saline, Sodium Chlorine (NaCl; 0.9%), was used as the negative irritant control in the CIT portion of the study

    Outcomes

    Primary Outcome Measures

    Visual assessment (Patch assessment)
    An overall average skin grade is calculated (i.e. the sum of the daily average skin grades divided by the number of study days) for each test substance. An overall skin grade is a representation of average skin reaction during the study.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 15, 2018
    Last Updated
    November 5, 2018
    Sponsor
    Haus Bioceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03406117
    Brief Title
    A Study to Determine the Safety and Sensitizing Potential of HAT1 Topical Products Using Skin Sensitivity Patch Tests
    Official Title
    A Study to Determine the Dermatological Safety and Sensitizing Potential of HAT1 Topical Products Using Cumulative Irritation, Phototoxicity, and Repeated Insult Patch Tests
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    June 26, 2016 (Actual)
    Study Completion Date
    July 21, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Haus Bioceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of this clinical study is to assess the irritation and sensitisation potential of HAT1 topical products after repeated patch applications to healthy human participants by following conventional Repeated Insult (HRIPT), Cumulative Irritation (CIT), and Phototoxicity (PT) methodologies under the supervision of dermatologists.
    Detailed Description
    For HRIPT, a total of 9 induction patches were applied at the rate of three patches per week for three weeks. The patch was retained in place for 48 hours during week days and 72 hrs over the weekend. Each induction patch was applied to the same site unless the degree of reaction to the test substance or the adhesive necessitates relocation. Two sites, adjacent to the original site, were available if patch relocation was deemed necessary. A rest period of 12-20 days between the final induction patch application and challenge patch application was provided. Challenge patches were applied 12-20 days after the last induction patch application. Patches were worn for 48 hours (± 1 hour), then removed at the site and discarded. For PT, the test products along with a blank chamber as negative control were applied on the back of the subjects in contralateral paired symmetry under occlusion for 24 hours. After completion of 24 hours of occlusion, both patch systems were taken off. Subjects were acclimatized for 30 minutes post removal of the patch and dermatological assessment of the sites (including controls) was performed. Post assessment, one of the two sites and an untreated blank control site (randomized and investigator blinded) was irradiated with 0.5 MED (specific for each subject). Follow up assessments were performed at 10 minutes post irradiation and subsequently at 24 and 48 hours post irradiation. For CIT, the patches were prepared in a vertical row and applications were made every day for 14 days. All applications for individual test substances were made to the same site (the site used for the initial patch application) unless reactions become so strong (grade of 2.0 or greater) as to make continued application inadvisable. Patches were worn for approximately 23 hours (± 1 hour). Subjects were instructed to keep their patches dry. Subjects were instructed to return to the test facility for patch removal and disposal by test facility personnel. Skin sites were gently wiped with water and patted dry to remove excess test substance immediately following patch removal. Skin sites were graded approximately 20-40 minutes following patch removal. Subjects were not allowed to replace any patches that fall off. Subjects were provided with instructions and a schedule of the study dates on the first day of the study. Telephone numbers were provided to report adverse events or answer questions on a 24-hour basis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy, Atopic Dermatitis, Psoriasis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    182 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HAT1-EPBF2
    Arm Type
    Experimental
    Arm Description
    CIT was conducted over a period of approximately 15 days for each subject to determine the irritation and/or sensitization potential of a test material(s) under occlusion by 14 repeated closed occlusive patch application every 24 hrs. A final grade was taken 24 hours following the last patch application. PT was conducted over a period of approximately 6 days for each subject to determine the phototoxicity of the test product. HRIPT was conducted over a period of approximately 6-8 weeks for each subject to confirm that the test substances will not produce evidence of delayed contact sensitization following external contact with the skin by means of a repeated patch application procedure.
    Arm Title
    HAT1-HMF3
    Arm Type
    Experimental
    Arm Description
    CIT was conducted over a period of approximately 15 days for each subject to determine the irritation and/or sensitization potential of a test material(s) under occlusion by 14 repeated closed occlusive patch application every 24 hrs. A final grade was taken 24 hours following the last patch application. PT was conducted over a period of approximately 6 days for each subject to determine the phototoxicity of the test product. HRIPT was conducted over a period of approximately 6-8 weeks for each subject to confirm that the test substances will not produce evidence of delayed contact sensitization following external contact with the skin by means of a repeated patch application procedure.
    Arm Title
    Saline Solution: Sodium Chloride
    Arm Type
    Active Comparator
    Arm Description
    Saline, Sodium Chlorine (NaCl; 0.9%), was used as the negative irritant control in the CIT portion of the study
    Intervention Type
    Drug
    Intervention Name(s)
    HAT1
    Other Intervention Name(s)
    HAT01
    Intervention Description
    All the participants will have the test product applied to the appropriate test sites by trained study staff. The study was conducted on a mixed population comprising of normal subjects, and patients with atopic dermatitis and active plaque psoriasis.
    Intervention Type
    Other
    Intervention Name(s)
    Saline Solution
    Other Intervention Name(s)
    Sodium Chloride
    Intervention Description
    Only for CIT portion of the study. Participant will have product applied topically on site by the trained study staff.
    Primary Outcome Measure Information:
    Title
    Visual assessment (Patch assessment)
    Description
    An overall average skin grade is calculated (i.e. the sum of the daily average skin grades divided by the number of study days) for each test substance. An overall skin grade is a representation of average skin reaction during the study.
    Time Frame
    Upto Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    The study population in this report comprises of healthy normal subjects, patients with active plaque psoriasis, and patients with atopic dermatitis. Inclusion Criteria: Males or females 18 years of age or older - no more than 20% of the panel should be comprised of subjects over the age of 65. In general good health as determined by the Medical and Dermatological History Questionnaire, or as having diagnosed with atopic dermatitis confirmed by the investigating dermatologist, or as having diagnosed with active plaque psoriasis confirmed by the investigating dermatologist. Able to read, understand and sign an informed consent agreement after being advised of the nature of the study. Willing to refrain from using lotions, creams, powders or other skin preparations on the skin in the test area for the duration of the study. Willing to refrain from exposing skin sites to the sun or going to tanning beds for the duration of the study. Exclusion Criteria: Have a clinical diagnosis of a dermatological condition other that atopic dermatitis or psoriasis (such as contact dermatitis, cutaneous lymphoma, tinea corpori's, etc.), or have non plaque forms of psoriasis (for example, erythrodermic, guttate, or pustular), or have bacterial infections of the skin, including impetigo or abscesses. Have a history of skin cancer or have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months. Have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk. Have pigmentation, extensive scarring, or pigmented lesions in the patch areas, which could interfere with the scoring. Have had a mastectomy or axillary lymph nodes removed. Have an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.). Are currently taking any immunosuppressant medication 8. Have insulin-dependent diabetes. Have asthma or any other chronic respiratory condition requiring daily therapy Are currently using on a routine or frequent basis antihistamines or any systemic or topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.). Maximum acceptable dosage should be determined by written laboratory guidelines. Have used a topical anti-inflammatory in the patch area within the last 2 weeks Are currently receiving allergy injections, expects to start injections before the conclusion of the study or has had the final injection within a week of the study start Are currently participating in another dermal study of any kind Are currently participating in any clinical study, which in the judgment of the Investigator or Designate, could potentially affect responses in either study. Have a confirmed skin allergy as a result of participation in a patch study. Have a known sensitivity or allergy relating to the substance(s) being evaluated. Have a known sensitivity or allergy to adhesives, surgical tapes, bandages, etc. Have scars, moles, sunburn, tattoos, etc. in the patch area.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    P Alex, M.D.
    Organizational Affiliation
    Study Director
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Determine the Safety and Sensitizing Potential of HAT1 Topical Products Using Skin Sensitivity Patch Tests

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