Healthy VolunteersPhase 1NCT04882631
A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants
A Phase 1 study testing PBI-100 Topical Cream in people with Healthy Volunteers, run by Pyramid Biosciences at 1 site in United States.
Trial summary
This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PBI-100 Topical Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 3 May 2021
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male and female volunteers between the ages of 18 and 70 years with Fitzpatrick types I, II, or III.
- Must be willing to follow the study requirements and voluntarily give their informed consent.
- Subjects must be able to read and follow study instructions in English.
- Generally in good health as determined by the investigator, based on medical history interview.
- Evidence of a personally signed and dated Informed Consent indicating that the subject has been informed of and understood all pertinent aspects of the trial.
Who cannot join
- Scars, moles, or other blemishes over the forearm, upper arm, or back that interfere with the study.
- Sunburn within the last three weeks or use of tanning beds.
- History of allergy or hypersensitivity to skin care or consumer products including fragrances, cosmetics, toiletries, or any kind of tape.
- History of chronic or recurrent dermatological diseases, e.g., psoriasis, atopic eczema, chronic urticaria.
- Subjects receiving systemic or topical drugs which can interfere with the development of an inflammatory response, e.g., steroids, immunosuppressive agents, or retinoids.
- History of any significant systemic diseases e.g., cardiac, pulmonary, renal, hepatic, etc. that would impact subject's ability to complete the study.
- Pregnancy or mothers who are breastfeeding or planning a pregnancy.
- Other conditions considered by the Investigator as sound reasons for disqualification from enrollment into the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
KGL Skin Study Center
Newtown Square, Pennsylvania, 19073
About this study
Official title: A 21 Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants Using a Cumulative Irritant Patch Test Design
This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.
Read the detailed description
This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days. Three concentrations of PBI-100 Topical Cream and vehicle (placebo cream) will be applied to the skin of each subject. In addition, one site will be treated with a positive control and another site will be treated with a plain cotton cloth patch and will serve as a negative control.
- Conditions
- Healthy Volunteers
- Being tested
- PBI-100 Topical Cream, Positive Control - Sodium laurel sulfate (SLS), PBI-100 Topical Cream, Vehicle, Negative Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBI-100 Topical CreamDrug
A dose of approximately 560 ug (approximately 0.4 mL of each of the three concentrations to 3 different sites) of PBI-100 was applied daily (excluding weekends) to the skin test sites.
Positive Control - Sodium laurel sulfate (SLS)Drug
Also called SLS
Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site.
PBI-100 Topical Cream, VehicleOther
Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site.
Negative ControlOther
A blank patch was applied daily (excluding weekends) as a negative control test site.
| Study group | Role | What they receive |
|---|---|---|
| Cumulative Irritation Test | Experimental | Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications. Receives: Drug: PBI-100 Topical Cream; Drug: Positive Control - Sodium laurel sulfate (SLS); Other: PBI-100 Topical Cream, Vehicle; Other: Negative Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritation Potential
Irritation potential based on the Cumulative Irritation Index (CII)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start12 Apr 2021
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The order of test product patch placement is randomized.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pyramid Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Pyramid Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882631
- Sponsor's protocol ID
- PBI-100-101
- Status last verified
- Jan 2022
- First submitted
- 6 May 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 21 Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants Using a Cumulative Irritant Patch Test Design
- ClinicalTrials.gov ID
- NCT04882631
- Acronym / sponsor ID
- PBI-100-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pyramid BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 12 May 2021 (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.
This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.
Detailed description
This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days. Three concentrations of PBI-100 Topical Cream and vehicle (placebo cream) will be applied to the skin of each subject. In addition, one site will be treated with a positive control and another site will be treated with a plain cotton cloth patch and will serve as a negative control.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The order of test product patch placement is randomized.
| Arm | Type | Receives |
|---|---|---|
| Cumulative Irritation Test | Experimental | Drug: PBI-100 Topical Cream, Drug: Positive Control - Sodium laurel sulfate (SLS), Other: PBI-100 Topical Cream, Vehicle, Other: Negative ControlParticipants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adult male and female volunteers between the ages of 18 and 70 years with Fitzpatrick types I, II, or III.
- Must be willing to follow the study requirements and voluntarily give their informed consent.
- Subjects must be able to read and follow study instructions in English.
- Generally in good health as determined by the investigator, based on medical history interview.
- Evidence of a personally signed and dated Informed Consent indicating that the subject has been informed of and understood all pertinent aspects of the trial.
Key exclusion criteria (8 listed)
- Scars, moles, or other blemishes over the forearm, upper arm, or back that interfere with the study.
- Sunburn within the last three weeks or use of tanning beds.
- History of allergy or hypersensitivity to skin care or consumer products including fragrances, cosmetics, toiletries, or any kind of tape.
- History of chronic or recurrent dermatological diseases, e.g., psoriasis, atopic eczema, chronic urticaria.
- Subjects receiving systemic or topical drugs which can interfere with the development of an inflammatory response, e.g., steroids, immunosuppressive agents, or retinoids.
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 |
|---|---|---|
| PBI-100 Topical CreamA dose of approximately 560 ug (approximately 0.4 mL of each of the three concentrations to 3 different sites) of PBI-100 was applied daily (excluding weekends) to the skin test sites. | Drug | Cumulative Irritation Test |
| Positive Control - Sodium laurel sulfate (SLS)Also: SLSApproximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site. | Drug | Cumulative Irritation Test |
| PBI-100 Topical Cream, VehicleApproximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site. | Other | Cumulative Irritation Test |
| Negative ControlA blank patch was applied daily (excluding weekends) as a negative control test site. | Other | Cumulative Irritation Test |
Primary outcome
Irritation Potential
Time frame: 21 days
Irritation potential based on the Cumulative Irritation Index (CII)
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 27 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Chief Medical Officer study director
Pyramid Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBI-100 Topical Cream in people with Healthy Volunteers, run by Pyramid Biosciences at 1 site in United States.
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 8 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 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Irritation Potential (time frame: 21 days). 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 27 Jan 2022.