Phase 2
N=68
A Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02404285 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. — -27; -44 % change of inflammatory lesions count — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Next Science Acne Gel (Drug); Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Next Science TM
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. |
-27; -44 | <0.01 sig |
| SECONDARY Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment. |
-6.5; -34.1 | — |
| SECONDARY Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks. |
2.8; 2.4; 2.3; 2.0 | <0.001 sig |
| SECONDARY Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks. |
.5; .5; 0.4; 0.3 | — |
| SECONDARY Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks. |
.3; .3; 0.3; 0.1 | — |
| SECONDARY Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks. |
.1; 0; 0; 0.1 | — |
| SECONDARY Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks. |
0; 0; 0; 0 | — |
| SECONDARY Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks. |
.2; 0.1; 0.1; 0 | — |
| SECONDARY Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks. |
.1; .1; 0; 0 | — |
| SECONDARY Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks. |
.2; .1; 0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02404285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.