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

NCT ID: NCT02404285

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-09-30

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.

Detailed Description

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:

1. Lesion counts with photography

2. Investigator Global Assessment

3. Acne Quality of Life Questionnaire

4. 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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vehicle

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

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

Next Science Acne Gel

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female ages 12 and above

2. Has 10 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment.

3. 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

4. Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation

5. Agrees to refrain from professional facial treatments during their trial participation.

6. Agrees to avoid tanning booth use and minimize sun exposure during their trial participation.

7. Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site

8. 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

1. Has more than 2 nodules/cystic acne lesions on the face

2. Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients

3. Has any history of skin malignancy

4. Has significant facial hair that would interfere with evaluation of acne lesions or global assessment.

5. Has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization.

6. 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).

7. Has had any professional facial treatments in the 14 days prior to randomization.

8. Has received any investigational treatment in the 30 days prior to randomization.

9. Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jacksonville Center For Clinical Research

OTHER

Sponsor Role: collaborator

St. Johns Center for Clinical Research

UNKNOWN

Sponsor Role: collaborator

Fleming Island Center for Clinical Research

UNKNOWN

Sponsor Role: collaborator

Next Science TM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Greco, MD

Role: STUDY_DIRECTOR

Jacksonville Center For Clinical Research

Annabelle Matias, MD

Role: PRINCIPAL_INVESTIGATOR

Fleming Island Center for Clinical Research

Lara Church, MD

Role: PRINCIPAL_INVESTIGATOR

St John's Center for Clinical Research

Locations

Fleming Island Center for Clinical Research

Jacksonville, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

St. Johns Center for Clinical Research

Ponte Vedra, Florida, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27272073 (View on PubMed)

Other Identifiers

CSP-003

Identifier Type: -

Identifier Source: org_study_id