TendinopathyPhase 1NCT03502434
A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers
A Phase 1 study testing SM04755, White Petrolatum and Sodium lauryl sulfate in people with Tendinopathy, run by Biosplice Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a single center, randomized, controlled, within subject comparison, single dose study to determine the sensitization potential of SM04755 solution on normal skin under semi-occlusive patch conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy
- What is being tested?
- SM04755, White Petrolatum and Sodium lauryl sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 17 Nov 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult males and females at least 18 years of age
- Subjects of any Fitzpatrick skin type or race provided their degree of skin pigmentation does not, in the Investigator or designee's opinion, interfere with study assessments
- Subject has no signs of irritation (i.e., a Reaction Grade of "0") at patch application sites on the back prior to the initial patch application on Day 1
- Subject must have read, understood, and signed the informed consent form prior to any study-related procedure being performed
- Subject is willing and able to comply with all scheduled study visits, urine pregnancy tests (if applicable), contraception requirements (male and female), and other study requirements
- Subject is willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon for the duration of the study
Who cannot join
- Women who are pregnant or lactating
- Women of childbearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period that includes double barrier, IUD, or hormonal contraceptive combined with single barrier, or abstinence
- Women of childbearing potential who have had unprotected sexual intercourse within 30 days prior to Day 1
- Males who are sexually active and not willing to use a condom, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use double barrier or whose partner is not using a highly effective method of birth control (e.g., IUD, or hormonal contraception combined with single barrier)
- Subject has any skin condition that, in the Investigator's opinion, could interfere with the study assessments or put the subject at undue risk by study participation
- Subject has severe atopic dermatitis/eczema, psoriasis or chronic asthma
Show all 17Show fewer
- Subject has tattoos, excessive hair, moles, scarring, etc. which would interfere with patching
- Subject has a history of sensitivity to any component of any of the Test Materials
- Use of any of the following medications:
- Systemic or topical glucocorticoids within 4 weeks prior to Day 1
- Systemic or topical analgesics (e.g., NSAIDs, high dose aspirin, etc.) within 1 week prior to Day 1. Note: Daily use of ≤325 mg of aspirin for cardiovascular disease or prophylaxis is allowed. Maximum daily use of Tylenol ≤3000 mg is allowed.
- Antihistamines within 1 week prior to Day 1. Note: H2 blockers such as Pepcid, Zantac, and Tagamet are permitted.
- Anti-inflammatories within 1 week prior to Day 1
- Immunosuppressant medications (e.g., TNF-alpha inhibitors, topical tacrolimus, etc.) within 4 weeks prior to Day 1 (or within 6 half-lives prior to Day 1 for biologics)
- Subject has had previous treatment with SM04755
- Subject has an active infection of hepatitis B or C or human immunodeficiency virus (HIV) infection as determined by an interview
- Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 8 weeks prior to Screening, or planned participation in any such trial; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 8 weeks prior to Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution
This is a single center, randomized, controlled, within subject comparison, single dose study to determine the sensitization potential of SM04755 solution on normal skin under semi-occlusive patch conditions.
Read the detailed description
This Phase 1, Repeat Insult Patch Test (RIPT) study is a single-center study of topical SM04755 solution repetitively applied to skin of healthy volunteers. This study will assess the potential of the Test Materials to induce contact sensitization as measured by treatment emergent adverse events (TEAEs), Reaction Grade and Investigator assessment of irritation and sensitization.
- Conditions
- Tendinopathy
- Being tested
- SM04755, Vehicle, White Petrolatum, Sodium lauryl sulfate
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM04755Drug
Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
VehicleOther
Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
White PetrolatumOther
Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
Sodium lauryl sulfateOther
Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
| Study group | Role | What they receive |
|---|---|---|
| 90 mg/mL SM04755 in water | Experimental | 90 mg/mL SM04755 in water applied via patches Receives: Drug: SM04755 |
| 90 mg/mL SM04755 in aqueous Vehicle | Experimental | 90 mg/mL SM04755 in aqueous Vehicle applied via patches Receives: Drug: SM04755 |
| 90 mg/mL SM04755 in aqueous Vehicle (without Benzyl Alcohol) | Experimental | 90 mg/mL SM04755 in aqueous Vehicle (without Benzyl Alcohol) applied via patches Receives: Drug: SM04755 |
| Vehicle | Other | Aqueous Vehicle applied via patches Receives: Other: Vehicle |
| White petrolatum | Other | White petrolatum (Negative control) applied via patches Receives: Other: White Petrolatum |
| Sodium lauryl sulfate | Other | Sodium lauryl sulfate (SLS 0.5%) (Positive control) applied via patches Receives: Other: Sodium lauryl sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact sensitization potential of Test Material as measured by Treatment emergent
Measured: Baseline to Day 40 (or through the observation period for TEAEs)
Contact sensitization potential of Test Material as measured by Reaction Grade
Reaction Grade is measured on a 5-point scale from zero to four (zero = no sign of irritation and 4 = Erythema with edema and blistering)
Measured: Baseline to Day 38-40
Contact sensitization potential of Test Material as measured by Investigator assessment of irritation and sensitization
Measured: Baseline to Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start11 Sep 2017
- Primary completion17 Nov 2017
- Study completion17 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusuf Yazici, M.D., Study director, Biosplice Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502434
- Sponsor's protocol ID
- SM04755-TOP-02
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2018
- Last updated
- 1 Oct 2026
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution
- ClinicalTrials.gov ID
- NCT03502434
- Acronym / sponsor ID
- SM04755-TOP-02
- Conditions
- Tendinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 18 Apr 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.
This is a single center, randomized, controlled, within subject comparison, single dose study to determine the sensitization potential of SM04755 solution on normal skin under semi-occlusive patch conditions.
Detailed description
This Phase 1, Repeat Insult Patch Test (RIPT) study is a single-center study of topical SM04755 solution repetitively applied to skin of healthy volunteers. This study will assess the potential of the Test Materials to induce contact sensitization as measured by treatment emergent adverse events (TEAEs), Reaction Grade and Investigator assessment of irritation and sensitization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 90 mg/mL SM04755 in water | Experimental | Drug: SM0475590 mg/mL SM04755 in water applied via patches |
| 90 mg/mL SM04755 in aqueous Vehicle | Experimental | Drug: SM0475590 mg/mL SM04755 in aqueous Vehicle applied via patches |
| 90 mg/mL SM04755 in aqueous Vehicle (without Benzyl Alcohol) | Experimental | Drug: SM0475590 mg/mL SM04755 in aqueous Vehicle (without Benzyl Alcohol) applied via patches |
| Vehicle | Other | Other: VehicleAqueous Vehicle applied via patches |
| White petrolatum | Other | Other: White PetrolatumWhite petrolatum (Negative control) applied via patches |
| Sodium lauryl sulfate | Other | Other: Sodium lauryl sulfateSodium lauryl sulfate (SLS 0.5%) (Positive control) applied via patches |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult males and females at least 18 years of age
- Subjects of any Fitzpatrick skin type or race provided their degree of skin pigmentation does not, in the Investigator or designee's opinion, interfere with study assessments
- Subject has no signs of irritation (i.e., a Reaction Grade of "0") at patch application sites on the back prior to the initial patch application on Day 1
- Subject must have read, understood, and signed the informed consent form prior to any study-related procedure being performed
- Subject is willing and able to comply with all scheduled study visits, urine pregnancy tests (if applicable), contraception requirements (male and female), and other study requirements
Key exclusion criteria (17 listed)
- Women who are pregnant or lactating
- Women of childbearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period that includes double barrier, IUD, or hormonal contraceptive combined with single barrier, or abstinence
- Women of childbearing potential who have had unprotected sexual intercourse within 30 days prior to Day 1
- Males who are sexually active and not willing to use a condom, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use double barrier or whose partner is not using a highly effective method of birth control (e.g., IUD, or hormonal contraception combined with single barrier)
- Subject has any skin condition that, in the Investigator's opinion, could interfere with the study assessments or put the subject at undue risk by study participation
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 |
|---|---|---|
| SM04755Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading. | Drug | 90 mg/mL SM04755 in aqueous Vehicle, 90 mg/mL SM04755 in aqueous Vehicle (without Benzyl Alcohol), 90 mg/mL SM04755 in water |
| VehicleHealthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading. | Other | Vehicle |
| White PetrolatumHealthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading. | Other | White petrolatum |
| Sodium lauryl sulfateHealthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading. | Other | Sodium lauryl sulfate |
Primary outcome
Contact sensitization potential of Test Material as measured by Treatment emergent
Time frame: Baseline to Day 40 (or through the observation period for TEAEs)
Contact sensitization potential of Test Material as measured by Reaction Grade
Time frame: Baseline to Day 38-40
Reaction Grade is measured on a 5-point scale from zero to four (zero = no sign of irritation and 4 = Erythema with edema and blistering)
Contact sensitization potential of Test Material as measured by Investigator assessment of irritation and sensitization
Time frame: Baseline to Day 40
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 1 Oct 2026.
- 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.
Yusuf Yazici, M.D. study director
Biosplice Therapeutics, Inc.
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 SM04755, White Petrolatum and Sodium lauryl sulfate in people with Tendinopathy, run by Biosplice Therapeutics, Inc. 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 6 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 1 Oct 2026. 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?
Contact sensitization potential of Test Material as measured by Treatment emergent (time frame: Baseline to Day 40 (or through the observation period for TEAEs)). The study lists 3 primary outcomes in all. 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 1 Oct 2026.