RECRUITING

Self-Administered Intralesional Injections for Acne

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to test the safety of intralesional injections of triamcinolone self-administered into acne lesions via an injection assistance device. The main question\[s\] it aims to answer are: * is use of the injection assistance device safe? * is delivery of triamcinolone to acne lesions via the injection assistance device efficacious? Participants will self-inject low dose triamcinolone into acne lesions and track lesion response via photos and survey for 14 days following injection.

Official Title

Patient Self-Administered Intralesional Injections of Triamcinolone for Acne Vulgaris

Quick Facts

Study Start:2023-02-01

Study Completion:2024-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06186596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline. 2. Diagnosed with facial acne vulgaris. 3. At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is clinically indicated for standard-of-care intralesional injection(s) of triamcinolone. 4. Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play. 5. Able to follow study instructions and likely to comply with virtual follow-up requirements. 6. In good general health as determined by medical history at the time of screening (Investigator discretion). 7. Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related procedures being performed.	1. Female subjects who are pregnant or breast-feeding. 2. Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection. 3. Active cutaneous viral infection in any treatment area at Baseline. 4. Have concomitant skin disease or infection (other than acne) or presence of skin comorbidities in the areas of skin where study device will be used. 5. History of poor cooperation or unreliability (Investigator discretion). 6. Subjects who are investigational site staff members or family members of such employees. 7. Exposure to any other investigational device within 30 days prior to Visit 1.

Inclusion Criteria

Exclusion Criteria

1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline.
2. Diagnosed with facial acne vulgaris.
3. At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is clinically indicated for standard-of-care intralesional injection(s) of triamcinolone.
4. Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play.
5. Able to follow study instructions and likely to comply with virtual follow-up requirements.
6. In good general health as determined by medical history at the time of screening (Investigator discretion).
7. Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related procedures being performed.

1. Female subjects who are pregnant or breast-feeding.
2. Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.
3. Active cutaneous viral infection in any treatment area at Baseline.
4. Have concomitant skin disease or infection (other than acne) or presence of skin comorbidities in the areas of skin where study device will be used.
5. History of poor cooperation or unreliability (Investigator discretion).
6. Subjects who are investigational site staff members or family members of such employees.
7. Exposure to any other investigational device within 30 days prior to Visit 1.

Contacts and Locations

Study Contact

Lyra Olson, PhD

CONTACT

5142096452

lolson@atomic.vc

Study Locations (Sites)

Center For Dermatology Clinical Research, Inc

Fremont, California, 94538

United States

Skin Care Research

Boca Raton, Florida, 33486

United States

Skin Care Research

Hollywood, Florida, 33021

United States

Collaborators and Investigators

Sponsor: ACOM Labs

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01

Study Completion Date2024-01-31

Study Record Updates

Study Start Date2023-02-01

Study Completion Date2024-01-31

Terms related to this study

Additional Relevant MeSH Terms

Acne Vulgaris