Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.

Acne Vulgaris Clinical Trial

Official title:

A Single-center, Double-blind, Controlled Study to Evaluate the Effect of Next Science™ Acne Cream on Mild to Moderate Facial Acne in Adult Females Over 6 Months.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03106766
• Other study ID #: CSP-004
• Status: Terminated
• Phase: Early Phase 1
• First received: March 27, 2017
• Last updated: August 28, 2017
• Start date: March 27, 2017
• Est. completion date: August 14, 2017

Study information

• Verified date: August 2017
• Source: Next Science TM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream 1x in a double blind manner.

Description:

This is a 6-month, single-site, double-blind, controlled study in 20 female subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical Next Science™ acne cream 2x or Next Science™ acne cream 1x daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 6, 12, 18 and 24 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 14, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female ages 18 and above

2. Has 20 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.

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

5. 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).

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

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

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Acne cream 2X
Twice daily application of facial acne cream 2X after facial cleansing
• Acne cream 1X
Twice daily application of facial acne cream 1X after facial cleansing

Locations

Country	Name	City	State
United States	Skin Laser & Surgery Specialists of NY & NJ	Hackensack	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Next Science TM	Skin Laser & Surgery Specialists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Lesion Count	Inflammatory acne lesions with both study acne cream products after 6 months of treatment compared to baseline. This will be measured as the mean percent change from baseline to week 24 in the inflammatory lesion count.	Baseline versus 6 months
Secondary	Inflammatory Lesion count over time	to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 inflammatory lesion counts	weeks 6, 12, 18, and 24
Secondary	Non-inflammatory acne lesion over time	to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in non-inflammatory lesion counts	weeks 6, 12, 18, and 24
Secondary	Investigator Global Assessment over time	to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in IGA	weeks 6, 12, 18, and 24
Secondary	Treatment Areas over time	to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in treatment areas (erythema, dryness, stinging or burning, erosion, edema, pain and itching)	weeks 6, 12, 18, and 24
Secondary	Quality of Life over time	The Acne-QoL questionnaire containing 19 questions organized into four domains which address the impact of facial acne on health-related quality of life will be administered. These are Self Perception, Role-social, Role-emotional and Acne Symptoms. Results will assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in QoL.	weeks 6, 12, 18, and 24