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A Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne

NCT02404285 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-11-08

Study results available
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Summary

This is a 12 week, multi-site, double-blind, vehicle-controlled study in subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical NAG or vehicle gel daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Next Science Acne Gel

Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

DRUG

Vehicle

Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Sponsors & Collaborators

  • Jacksonville Center For Clinical Research

    collaborator OTHER

  • St. Johns Center for Clinical Research

    collaborator UNKNOWN

  • Fleming Island Center for Clinical Research

    collaborator UNKNOWN

  • Next Science TM

    lead INDUSTRY

Principal Investigators

  • Susan Greco, MD · Jacksonville Center For Clinical Research

  • Annabelle Matias, MD · Fleming Island Center for Clinical Research

  • Lara Church, MD · St John's Center for Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02404285 on ClinicalTrials.gov