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

NCT03406117 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: HCTP16MD0204
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy; Atopic Dermatitis; Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  Upto Week 8

Study Arms (3)

HAT1-EPBF2

EXPERIMENTAL

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.

Drug: HAT1

HAT1-HMF3

EXPERIMENTAL

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.

Drug: HAT1

Saline Solution: Sodium Chloride

ACTIVE COMPARATOR

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

Other: Saline Solution

Interventions

HAT1 DRUG

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.

Also known as: HAT01

HAT1-EPBF2; HAT1-HMF3

Saline Solution OTHER

Only for CIT portion of the study. Participant will have product applied topically on site by the trained study staff.

Also known as: Sodium Chloride

Saline Solution: Sodium Chloride

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haus Bioceuticals: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• P Alex, M.D.

  Study Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 23, 2018
• Study Start: April 1, 2016
• Primary Completion: June 26, 2016
• Study Completion: July 21, 2016
• Last Updated: November 6, 2018

Record last verified: 2018-11