Acne Vulgaris Clinical Trial
Official title:
A Multi-Center, Double Blind, Vehicle Controlled, Study of Retin-A Micro 0.04% in the Treatment of Pediatric Acne Vulgaris in Children, Ages 9 to 11 Years of Age
A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.
Approximately 100 female and male subjects, aged from 9 to 11 years of age, will be enrolled
in this randomized, double blind, multi-center study.
Following satisfaction of entry criteria and screening procedures, subjects will receive
either RETIN-A MICRO 0.04% or a color matched gel vehicle for once daily use during the
12-week treatment period. Subjects will be monitored for safety throughout the study and for
signs and symptoms of local irritation at baseline, and at weeks 2, 4, 6, 8, 10 and again at
study completion, week 12.
Efficacy will be assessed by facial lesion counts and by utilizing scales for Investigator's
Global Evaluation of Acne Severity (IGA #1 and IGA #2) and Investigator's Global Assessment
of Improvement (IGA #3). All efficacy parameters with the exception of IGA #3 will be
measured at baseline and weeks 2, 4, 6, 8, 10 and 12. The Investigator's Global Assessment
of Improvement (IGA #3) will be done at Week 12 only. At selected sites, photographs will be
taken at Baseline and weeks 2, 4, 8 and 12.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04321070 -
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
|
Phase 1 | |
| Recruiting |
NCT05755256 -
The Impact of Probiotics on Skin Hydration in Youth With Mild Acne
|
Phase 2 | |
| Completed |
NCT05131373 -
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
|
Phase 1 | |
| Completed |
NCT01445301 -
Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
|
Phase 3 | |
| Completed |
NCT03303170 -
Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris
|
N/A | |
| Completed |
NCT04698239 -
Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.
|
N/A | |
| Completed |
NCT02886715 -
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
|
Phase 3 | |
| Terminated |
NCT02924428 -
Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris
|
N/A | |
| Completed |
NCT02709902 -
Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris
|
Phase 1 | |
| Not yet recruiting |
NCT02491060 -
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
|
Phase 3 | |
| Not yet recruiting |
NCT02535871 -
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
|
Phase 3 | |
| Not yet recruiting |
NCT02525822 -
Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris
|
Phase 2 | |
| Completed |
NCT02913001 -
The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
|
N/A | |
| Completed |
NCT02250430 -
A Phase 1 Study Assessing Local Cutaneous Effects of SB204
|
Phase 1 | |
| Completed |
NCT01769664 -
A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris
|
Phase 1 | |
| Completed |
NCT01694810 -
Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01727440 -
Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment
|
N/A | |
| Completed |
NCT01194375 -
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
|
Phase 2 | |
| Completed |
NCT01706250 -
U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™
|
Phase 4 | |
| Completed |
NCT00991198 -
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
|
Phase 2 |