Assessment of the Safety & Tolerability of Long-term Use of Patented Transdermal Patches in Healthy Adults.

• ClinicalTrials.gov Identifier: NCT04851990
• Recruitment Status: Completed
• First Posted: April 21, 2021
• Last Update Posted: August 5, 2021
• Sponsor: Horopito Limited
• Collaborator: Atlantia Food Clinical Trials
• Information provided by (Responsible Party): Horopito Limited

Tracking Information

• First Submitted Date: April 13, 2021
• First Posted Date: April 21, 2021
• Last Update Posted Date: August 5, 2021
• Actual Study Start Date: April 19, 2021
• Actual Primary Completion Date: July 16, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 19, 2021)

• Number of participants experiencing at least one treatment-emergent adverse event (TEAE) including causality, severity, and seriousness assessments. [ Time Frame: Baseline to week 8 ]
  Record number of individual participants experiencing TEAE
• Number of treatment-emergent adverse event (TEAE) including causality, severity, and seriousness assessments. [ Time Frame: Baseline to 8 weeks ]
  Record number of TEAE per treatment arm
• Number of participants with discontinuations due to AEs or TEAEs [ Time Frame: Baseline to 8 weeks ]
  Record any participants discontinued due to TEAE
• Change in Full Blood Count [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Change in blood lipids - total cholesterol, HDL and LDL, triglycerides mmol/l [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Change in Liver Function Tests - IU/l - alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gama-glutamyl transferase [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Change in blood glucose mmol/l [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Change in blood bilirubin mg/dl [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Change in blood calcium mg/dl [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Change in blood protein g/l - total protein, albumin & globulin [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Change in blood creatine mg/dl [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Change in blood urea mg/dl [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Change in blood uric acid mg/dl [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Change in blood electrolytes mmol/l - sodium, potassium, chloride, bicarbonate, magnesium & phosphate [ Time Frame: Baseline to week 8 ]
  Monitor blood safety parameters
• Baseline Serum Vitamin D (25-OH) nmol/l [ Time Frame: Baseline ]
  Monitor blood safety parameters
• Change in blood pressure - systolic blood pressure (mmHg) & diastolic blood pressure (mmHg) [ Time Frame: Baseline to 8 weeks ]
  Monitor safety measurements
• Change in heart rate (BPM) [ Time Frame: Baseline to 8 weeks ]
  Monitor safety measurements
• Change in body temperature (˚C) [ Time Frame: Baseline to 8 weeks ]
  Monitor safety measurements

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 19, 2021)

Change in serum vitamin D levels, measured using at-home self-administered finger prick -nmol/l [ Time Frame: Baseline - 8 weeks ]

Measure change to plasma vitamin D in response to daily patch application

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of the Safety & Tolerability of Long-term Use of Patented Transdermal Patches in Healthy Adults.
• Official Title: A Parallel Pilot Study to Assess the Safety and Tolerability of Long-term Use of Patented Transdermal Patches in Healthy Adults.
• Brief Summary: This is a pilot study to assess the safety and tolerability of long-term use of patented transdermal vitamin D patches in healthy adults.
• Detailed Description: A randomised, parallel, pilot study to assess the safety and tolerability of long-term use of patented transdermal patches in healthy adults. The study consists of 4 on-site visits: the Screening Visit (Visit 1, Week -2), the Baseline Visit (Visit 2, Week 0), Visit 3 (Week 4), and the End of Intervention Visit (Week 8).
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

2 Arms with 15 Subjects per group

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Vitamin D

Intervention

• Other: To Better Days Large Patch
  Large patch containing vitamin D & Dextrose for transdermal absorption
• Other: To Better Days Small Patch
  Small patch containing vitamin D & Dextrose for transdermal absorption

Study Arms

• Experimental: Large Patch

  To Better Days Large Patch

  1 patch applied daily by 9am - in situ for 24 hours Dosage: vitamin D 30,000 IU + dextrose 13mg

  Intervention: Other: To Better Days Large Patch
• Experimental: Small patch

  To Better Days Small Patch

  1 patch applied daily by 9am - in situ for 24 hours Dosage: vitamin D 30,000 IU + dextrose 13mg

  Intervention: Other: To Better Days Small Patch

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 19, 2021): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 20, 2021
• Actual Primary Completion Date: July 16, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 1. Individuals who are willing to participate in the study and comply with its procedures.

  2. Individuals who are able to give written informed consent. 3. Individuals between 18-70 years old. 4. Has a BMI between 18-32 kg/m2 (inclusive). 5. Individuals who are willing to not undertake overseas travel for the duration of the study or engage in excessive sun-exposure or use of sun lamps or tanning beds for the duration of the study.

  6. Individuals who are willing to maintain their current diet and not change supplement usage for the duration of the study.

  7. Individuals who are willing to self-administer finger prick sampling. 8. Individuals who are willing to avoid strenuous exercise or exposing the patch to external sources of direct heat e.g., heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight, while wearing the patch.

  9. Individuals willing to refrain from swimming or other sports involving immersion in water for the duration of the study.

  10. Individuals who have Serum 25-Hydroxyvitamin D concentration of ≥15 nmol/L and ≤100 nmol/L at screening.

Exclusion Criteria:

• 1. Are less than 18 or greater than 70 years old. 2. Participants who are pregnant, breastfeeding, or wish to become pregnant during the study.

  3. Individuals currently of childbearing potential, but not using an effective method of contraception, as outlined below:

  1. Complete abstinence from intercourse two weeks prior to administration of Investigational Product, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the Investigational Product in cases where participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
  2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
  3. Sexual partner(s) is/are exclusively female.
  4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm) or contraceptive pill. The participant must be using this method for at least 2 weeks prior to use of the Investigational Product and at least 1 week following the end of the study.

  5. Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1 % per year. The participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the study, and 2 weeks following the end of the study.

     4. Individuals who are hypersensitive to any of the components of the investigational product.

     5. Individuals who have a condition affecting the integrity of the skin (e.g., psoriasis or eczema).

     6. Individuals who are taking, or have taken, any prescribed or over the counter (OTC) drug and antacids, supplements, or herbal remedies in the 14 days before patch administration including any drugs known to interfere with vitamin D metabolism (e.g., steroids, orlistat, cholestyramine, phenytoin, statins, thiazide diuretics etc.). Occasional use of paracetamol up to a maximum of 2 g per day, hormone replacement therapy [HRT] or hormonal contraception are permissible.

     7. Individuals who have taken calcium supplements within the previous 8 weeks. 8. Individuals who are taking vitamin D supplements greater than 10 micrograms per day.

     9. Individuals with any history of or concurrent clinically significant diseases or conditions (e.g., kidney or liver dysfunction).

     10. Individuals with a known history of allergy to plasters or patches. 11. Individuals who have planned major changes in lifestyle (i.e., diet, dieting, exercise level, travelling) during the duration of the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ireland

Administrative Information

• NCT Number: NCT04851990
• Other Study ID Numbers: AFCRO-135
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Horopito Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Horopito Limited
• Original Study Sponsor: Same as current
• Collaborators: Atlantia Food Clinical Trials

Investigators

• Principal Investigator: Timothy Dinan; Atlantia Food Clinical Trials

• PRS Account: Horopito Limited
• Verification Date: August 2021