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Completed

NCT Number: NCT02404285

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fleming Island Center for Clinical Research, Jacksonville, Florida, United States

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About this study

Sample Size: N= 60 completed subjects Male and female subjects 12 years or older diagnosed with mild to moderate inflammatory facial acne vulgaris.

Subjects will be treated with once daily topical NAG or matching vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:

  • Lesion counts with photography
  • Investigator Global Assessment
  • Acne Quality of Life Questionnaire
  • Treatment Area Assessment by Investigator

Subjects will discontinue all baseline topical acne treatments with a 2 week washout and/or all systemic acne treatments with a 3 week washout. All subjects will be provided open label Cetaphil facial cleanser and double-blind NAG or vehicle product.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ages 12 and above
  • Has 10 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment.
  • In the area to be treated, has no significant facial dermatological conditions other than acne (as determined by the investigator) that would interfere with any study treatment or procedure
  • Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation
  • Agrees to refrain from professional facial treatments during their trial participation.
  • Agrees to avoid tanning booth use and minimize sun exposure during their trial participation.
  • Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site
  • Is able to read, understand and sign the informed consent document and communicate with study staff and investigator. If the subject is a minor, the parent or documented legal guardian must meet these consent requirements and the subject must be able to understand, agree to, and sign the assent form.

Exclusion criteria

  • Has more than 2 nodules/cystic acne lesions on the face
  • Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients
  • Has any history of skin malignancy
  • Has significant facial hair that would interfere with evaluation of acne lesions or global assessment.
  • Has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization.
  • Has used estrogens primarily as treatment for acne in the 21 days prior to randomization (estrogens prescribed for other reasons will be allowed if stable for at least 30 days prior to randomization).
  • Has had any professional facial treatments in the 14 days prior to randomization.
  • Has received any investigational treatment in the 30 days prior to randomization.
  • Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.

Treatment and study plan

Next Science Acne Gel

Drug

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.

Vehicle

Drug

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.

Primary outcomes

  1. Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use.

    Time frame: Baseline until 12 weeks

    Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use.

Secondary outcomes

  1. Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment.

    Time frame: 12 weeks

    Percent Change in Number of Non-inflammatory lesions (open and closed comedones) were counted after 12 weeks of either Vehicle of NAG treatment

  2. Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in Investigator Global Assessment (IGA) score (0-5) with daily use of NAG compared with vehicle after 12-weeks. IGA score is worse at 5, with improvement at lower scores (best at 0).

  3. Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in Erythema (measure of redness) scores with daily use of NAG compared with vehicle after 12-weeks.Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).

  4. Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in Dryness score with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).

  5. Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in Burning/Stinging scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).

  6. Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in Erosion scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).

  7. Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in Edema scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).

  8. Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in Pain scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).

  9. Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in Itching scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).

Other outcomes

  1. Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in Self Perception scores with daily use of NAG compared with vehicle after 12-weeks. The Acne Quality of Life (QoL) Questionnaire Form was used to determine the practical improvements in quality of life. The Acne-QoL form is a validated measure that contains 19 questions referring to the past week, organized into four area: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives.

  2. Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in Role-Emotional scores with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives

  3. Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in the subjects perception of their acne symptoms with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives

  4. Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks.

    Time frame: Baseline until 12 weeks

    Change in subjects social response to their acne with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives

Sponsors and collaborators

Lead sponsor

Next Science TM

Industry

Collaborators

  • Fleming Island Center for Clinical Research
  • Jacksonville Center For Clinical Research
  • St. Johns Center for Clinical Research

Registry information

Official study title

A Multi-center, Double-blind, Vehicle-controlled Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2015
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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