Not Yet RecruitingNot Applicable

CelluJuve® for the Treatment of Moderate to Severe NLFs

United States12 participantsStarted 2026-04-29

Plain-language summary

Single-center, open-label proof of concept study assessing the safety and effectiveness of CelluJuve® for the treatment of moderate to severe NLFs

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female of any race, 22 years of age or older, who are seeking therapy for correction of moderate to severe NLFs. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
✓. Moderate to severe bilateral NLFs with a severity grading of 3 or 4 as per the Wrinkle Severity Rating Scale (WSRS). Each NLF must have the same WSRS grade.
✓. Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations.
✓. Able to follow study instructions and complete all required visits.
✓. Signed ICF, Photographic Release, HIPAA, and if applicable the California Experimental Research Subject's Bill of Rights.

✕. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable contraception.
✕. A condition or situation that puts the subject at significant risk, may confound the study results, or may significantly interfere with subjects' study participation.
✕. Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse).
✕. Abnormal visual tests (i.e., Snellen acuity test worse than 20/40 with corrections, if applicable), abnormal confrontational visual field test, and/or abnormal ocular motility test.
✕. Subjects with known prolonged bleeding times due to disease or anticoagulants (e.g., warfarin). If on a drug or supplement that prolongs bleeding times (e.g., non-steroidal anti-inflammatory, anticoagulant, high-dose vitamin E, fish oil, corticosteroids), wait 7 days or until bleeding times return to normal before injecting. (Note: low dose 81mg/day ASA is permitted).
✕. Acute or chronic skin disease, inflammation, or related conditions, cancerous or precancerous lesions near the treatment area.
✕. Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to study treatment, or require interfering topical, systemic or surgical therapy.
✕. Herpes simplex lesion flare-ups greater than 6 per year.

Wrinkle Severity Rating Scale

Timeframe: 2 months, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months

NCT IDNCT07545980

SponsorSpiderwort Biotechnologies Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-15

Serpil Kucuktepe, PhD

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female of any race, 22 years of age or older, who are seeking therapy for correction of moderate to severe NLFs. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
✓. Moderate to severe bilateral NLFs with a severity grading of 3 or 4 as per the Wrinkle Severity Rating Scale (WSRS). Each NLF must have the same WSRS grade.
✓. Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations.
✓. Able to follow study instructions and complete all required visits.
✓. Signed ICF, Photographic Release, HIPAA, and if applicable the California Experimental Research Subject's Bill of Rights.

✕. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable contraception.
✕. A condition or situation that puts the subject at significant risk, may confound the study results, or may significantly interfere with subjects' study participation.
✕. Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse).
✕. Abnormal visual tests (i.e., Snellen acuity test worse than 20/40 with corrections, if applicable), abnormal confrontational visual field test, and/or abnormal ocular motility test.
✕. Subjects with known prolonged bleeding times due to disease or anticoagulants (e.g., warfarin). If on a drug or supplement that prolongs bleeding times (e.g., non-steroidal anti-inflammatory, anticoagulant, high-dose vitamin E, fish oil, corticosteroids), wait 7 days or until bleeding times return to normal before injecting. (Note: low dose 81mg/day ASA is permitted).
✕. Acute or chronic skin disease, inflammation, or related conditions, cancerous or precancerous lesions near the treatment area.
✕. Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to study treatment, or require interfering topical, systemic or surgical therapy.
✕. Herpes simplex lesion flare-ups greater than 6 per year.