| Eligibility |
Inclusion Criteria:
1. Ability to understand, agree to and sign the study Informed Consent Form (ICF). If the
subject is unable to provide consent him/herself, the subject's legally acceptable
representative may provide written consent.
2. Male or Female Subjects of any race 18 - 65 years of age.
3. Subjects with a clinical diagnosis of Tinea versicolor (TV is a common benign
superficial cutaneous fungal infection usually characterized by hypopigmented or
hyperpigmented macules and patches on the chest and back).
4. A positive potassium hydroxide (KOH) examination consistent with Malassezia prior to
the treatment period done at the clinical site.
5. Agree to not use soap and water on the chest and back for at least 12 hours before the
study visits for Baseline/Day 1, Day 5, and Day 14, and follow all study instructions
for use of soap and water on the chest and back during participation in the study.
Exclusion Criteria:
1. Females who are pregnant, planning a pregnancy, or breastfeeding.
2. Any dermatological conditions that could interfere with clinical evaluations or any
disease state or physical condition which might expose the patient to an unacceptable
risk by study participation.
3. Any underlying disease(s) or other dermatological conditions that require the use of
exclusionary topical or systemic therapy (see below).
4. Known sensitivity to any of the components of the study medication.
5. Use of a prescription or non-prescription topical treatment on the targeted TV
anatomical locations within the previous 4 weeks, for example: anti-fungal,
antibacterial or anti-microbial products, selenium and anti-inflammatories (e.g.,
corticosteroids).
6. Use of a systemic anti-fungal or antibiotic treatment for TV within the previous 4
weeks, Use of medicated shampoos and/or soaps within the previous 4 weeks.
7. Treatment of any type of cancer within the last 6 months.
8. History of any significant internal disease which contraindicates use of live
microbiome (e.g. leukemia, liver failure, cardiovascular disease).
9. Subjects who are known to be allergic to any of the test product(s) or any components
in the investigational product(s) or history of hypersensitivity or allergic reactions
to any of the study preparations as described in the Investigator's Brochure (IB).
10. AIDS or AIDS related complex by medical history.
11. Known or suspected use of immunosuppressive medications and/or has a known or
suspected autoimmune disease.
12. Any subject not able to meet the study attendance requirements.
13. Subjects who have participated in any other trial of an investigational drug or device
within 30 days prior to enrollment or participation in a research study concurrent
with this study.
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