None listed
Conditions
Brief summary
This study will enrol participants 6 months of age through age 13 with molluscum contagiosum (MC) across up to 6 sites in Australia. Participants will be randomly placed into one of two groups in a 2:1 ratio. This means twice as many children will receive the study treatment (Zabalafin Hydrogel) compared with those who receive the placebo. The purpose of the study is to see how well Zabalafin Hydrogel 9.5% works and how safe it is when used twice a day to treat MC. The main goal is to find out how many participants have more than 75% of their MC cleared by Week 16.
Interventions
Zabalafin Hydrogel 9.5%, A thin layer of the Zabalafin Hydrogel 9.5% gel will be applied to each MC lesion, twice daily, roughly 8 hours apart (around same time of the day) to all treatable MC lesions starting from Study Day 1 until the final dose at Day 112. Participants will be provided with a diary on Study Day 1 to record each daily gel application. The diary will be reviewed by the investigator at every study visit through Week 16.
Sponsors
Alphyn Biologics, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Months to 13 Years
Healthy volunteers
No
Inclusion criteria
1. Male/female participants who are 6 months of age up to and including 13 years of age on the day of providing documented informed consent/assent. 2. Have between 3 and 70 treatable Molluscum Contagiosum lesions at Day 1 visit; 3. All allowed oral and topical medications must be stable within the 14 days prior to Day 1. 4. Willing to refrain from using any topical products, including cosmetics and skin cleansers containing active ingredients on the Molluscum Contagiosum lesions during the study intervention application period 5. Participants who are willing and able to comply with all study procedures, including scheduled visits, proper administration of study intervention application, lifestyle considerations. 6. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a Women of Childbearing Potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance 7. The participant (or legally acceptable representative if applicable) provides documented informed consent/assent for the study.
Exclusion criteria
1. Have strongly suggested sexually transmitted WOCBP. 2. Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive treatment. This includes chemotherapies and oral/injectable treatments such as JAK inhibitors or monoclonal antibodies for atopic dermatitis. 3. Have significant injury on and/or surrounding WOCBP that may impact ability to treat and count lesions. 4. Have received treatment with topical calcineurin inhibitors or steroids on MC or within 2 cm of MC lesions within 14 days prior to Day 1. 5. Have received treatment for Molluscum Contagiosum during the 14 days prior to Day 1 with podophyllotoxin, imiquimod, cantharidin, sinecatechins, topical retinoids, berdazimer, or other homeopathic or over the counter (OTC) products including, but not limited to, benzoyl peroxide, ZymaDerm and tea tree oil, cimetidine and other histamine H2 receptor antagonists, or any agent that in the opinion of the Investigator may be relevant – (e.g. wart therapies). 6. Have received surgical procedures related to Molluscum Contagiosum (e.g. cryotherapy, curettage) within 14 days prior to Day 1. 7. Have Molluscum Contagiosum only in periocular area. 8. Have Molluscum Contagiosum that has been present for longer than 6 months. 9. Female participants who are pregnant, planning a pregnancy or breastfeeding. 10. Have known hypersensitivity to any ingredients of Zabalafin Hydrogel or Vehicle Gel. 11. History or presence of clinically significant medical, psychiatric, or emotional condition that, in opinion of the Investigator, would compromise the safety of the participant or the quality of the data. 12. A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation. 13. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccine and mRNA vaccines are allowed.
Outcome results
None listed