HealthyPhase 4NCT03406117
A Study to Determine the Safety and Sensitizing Potential of HAT1 Topical Products Using Skin Sensitivity Patch Tests
A Phase 4 study testing HAT1 and Saline Solution in people with Healthy and Atopic Dermatitis, run by Haus Bioceuticals.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Atopic Dermatitis, Psoriasis
- What is being tested?
- HAT1 and Saline Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 21 Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Show all 17Show fewer
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Healthy, Atopic Dermatitis, Psoriasis
- Being tested
- HAT1, Saline Solution
- Medical subject headings
- Dermatitis, Atopic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAT1Drug
Also called HAT01
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.
Saline SolutionOther
Also called Sodium Chloride
Only for CIT portion of the study. Participant will have product applied topically on site by the trained study staff.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upto Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Apr 2016
- Primary completion26 Jun 2016
- Study completion21 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haus Bioceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- P Alex, M.D., Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406117
- Sponsor's protocol ID
- HCTP16MD0204
- Status last verified
- Nov 2018
- First submitted
- 15 Jan 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03406117
- Acronym / sponsor ID
- HCTP16MD0204
- Conditions
- Healthy, Atopic Dermatitis, Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Haus BioceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 26 Jun 2016 (actual)
- Study completion
- 21 Jul 2016 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HAT1-EPBF2 | Experimental | Drug: HAT1CIT 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. |
| HAT1-HMF3 | Experimental | Drug: HAT1CIT 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 Solution: Sodium Chloride | Active comparator | Other: Saline SolutionSaline, Sodium Chlorine (NaCl; 0.9%), was used as the negative irritant control in the CIT portion of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAT1Also: HAT01All 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. | Drug | HAT1-EPBF2, HAT1-HMF3 |
| Saline SolutionAlso: Sodium ChlorideOnly for CIT portion of the study. Participant will have product applied topically on site by the trained study staff. | Other | Saline Solution: Sodium Chloride |
Primary outcome
Visual assessment (Patch assessment)
Time frame: Upto Week 8
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P Alex, M.D. study director
Study Director
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HAT1 and Saline Solution in people with Healthy and Atopic Dermatitis, run by Haus Bioceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual assessment (Patch assessment) (time frame: Upto Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.