None listed
Conditions
Brief summary
This study aims to demonstrate the safety and effectiveness of a wafer containing glutathione (an anti-oxidant) as a therapeutic skin health supplement. The treatment involves taking glutathione wafer under the tongue 2 times daily for 12 weeks.
Interventions
Participants will be randomly assigned to 1 of 3 treatment groups:
Cohort 1 will receive 100mg RadianiX™ dissolved under the tongue twice daily for 12 weeks. Cohort 2 will receive 200 mg RadianiX™ dissolved under the tongue twice daily for 12 weeks.
Cohort 3 will receive Placebo wafers dissolved under the tongue twice daily for 12 weeks.
Participants will complete a diary each time the medication is taken and will bring their diary and their study medication supply (including empty packaging)
Participants will be randomly assigned to 1 of 3 treatment groups: Cohort 1 will receive 100mg RadianiX™ dissolved under the tongue twice daily for 12 weeks. Cohort 2 will receive 200 mg RadianiX™ dissolved under the tongue twice daily for 12 weeks. Cohort 3 will receive Placebo wafers dissolved under the tongue twice daily for 12 weeks. Participants will complete a diary each time the medication is taken and will bring their diary and their study medication supply (including empty packaging) to clinic visits for review.
Sponsors
iX Biopharma Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Fitzpatrick skin type IV or V Good general health
Exclusion criteria
Use of glutathione products within the last 1 month. Personal history of skin cancer. Inappropriate for measurement in the skin area.
Outcome results
None listed