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

NCT02404285 | Completed Phase 1 Results

• 1 other identifier: CSP-003
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline until 12 weeks

Secondary Outcomes (9)

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

  12 weeks

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

  Baseline until 12 weeks

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

  Baseline until 12 weeks

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

  Baseline until 12 weeks

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

  Baseline until 12 weeks

Other Outcomes (4)

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

  Baseline until 12 weeks

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

  Baseline until 12 weeks

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

  Baseline until 12 weeks

Study Arms (2)

Vehicle

PLACEBO COMPARATOR

Subjects will be treated with once daily vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed: 1. Lesions will be counted and right, left and forward facing photographs will be taken 2. Investigator Global Assessment 3. Acne Quality of Life Questionnaire 4. Treatment Area Assessment by Investigator

Drug: Vehicle

NAG (Next Science Acne Gel)

ACTIVE COMPARATOR

Subjects will be treated with once daily NAG and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed: 1. Lesions will be counted and right, left and forward facing photographs will be taken 2. Investigator Global Assessment 3. Acne Quality of Life Questionnaire 4. Treatment Area Assessment by Investigator

Drug: Next Science Acne Gel

Interventions

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.

NAG (Next Science Acne 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.

Vehicle

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Next Science TM: lead
• Jacksonville Center For Clinical Research: collaborator
• St. Johns Center for Clinical Research: collaborator
• Fleming Island Center for Clinical Research: collaborator

Study Sites (3)

Fleming Island Center for Clinical Research

Jacksonville, Florida, 32203, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

St. Johns Center for Clinical Research

Ponte Vedra, Florida, 32081, United States

Location

Related Publications (1)

• Bernhardt MJ, Myntti MF. Topical Treatment With an Agent Disruptive to <em>P. acnes</em> Biofilm Provides Positive Therapeutic Response: Results of a Randomized Clinical Trial. J Drugs Dermatol. 2016 Jun 1;15(6):677-83.

  PMID: 27272073 RESULT

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Matt Myntti PHD, President
• Organization: Next Science

mmyntti@nextscience.org

9046474161

Study Officials

• Susan Greco, MD

  Jacksonville Center For Clinical Research

  STUDY DIRECTOR

• Annabelle Matias, MD

  Fleming Island Center for Clinical Research

  PRINCIPAL INVESTIGATOR

• Lara Church, MD

  St John's Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 8, 2023
• Results First Posted: March 29, 2019

Record last verified: 2023-11

Locations

US (3)