Restylane Silk Acne Scar Efficacy Evaluation Study

Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55
years old of all skin types will be asked to sign an informed consent form prior to any study
procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on
the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in
each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will
be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline
(Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit
visit). The blinded investigators will evaluate the target scar using the Acne Scar Rating
Scale (ASRS), rate the target acne scar regarding treatment effect on a -5 ("Markedly
worse"), to 0 ("Neutral Improvement"), to 5 (Markedly Improved (Clear or nearly clear)) point
scale, and evaluate the skin quality (regarding brightness, fullness, smoothness, and
clarity). Subjects will give the acne scar a score on the subject VAS acne scar satisfaction
scale marking between 0 ("Not satisfied with Acne Scar at Day 0") and 10 ("Extremely
Satisfied with Acne Scar at Day 0"). The treatment area will be evaluated at each visit by
the unblinded investigator regarding erythema, bruising, inflammation, itching,
stinging/burning, brightness, fullness, smoothness, and clarity. The subject will have their
vital signs taken, complete a symptom diary (only if the subject experiences side effects or
adverse events), complete a DLQI, and have photos (VECTRA and 2D digital photographs) taken
of the treatment area. Efficacy measures will only be completed by the blinded investigator.
Safety and adverse events will be captured at each visit only by the unblinded investigator.

Inclusion Criteria:

1. Male or non-pregnant female subjects on an acceptable form of birth control aged 22-55
years of age.

2. Willing to refrain from undergoing any procedures to repair or augment any acne scar
in the treatment area during the study.

3. Female subjects with a negative pregnancy test confirmed at screening and on an
acceptable form of birth control. Acceptable forms of birth control on this study
include oral or injectable contraceptive, contraceptive patches, Depo-Provera,
NuvaRing, Implanon, double barrier methods, IUD, same sex partner, or abstinence.
Males will be required to use an acceptable method of birth control: vasectomy,
double-barrier method, condom with spermicidal lube, or abstinence.

4. Signed informed consent prior to conducting any study procedures.

5. Willing to refrain from undergoing any cosmetic procedures in the treatment area
during the study.

6. At least one acne scar located on the cheeks or forehead to be ≥ 3 mm and ≤ 10 mm in
diameter, and rated as ≥3 on the ASRS at day 0. Subjects may have up to three
qualifying acne scars determined eligible for treatment at screening.

7. Acne scars that are classified as either ice pick, rolling, or boxcar acne scars.

8. ≤15 pustules/papules on the face at the time of screening and ≤ 2 nodules, and no
cysts at Baseline.

9. Willing to attend all study visits and comply with protocol

Exclusion Criteria:

1. Subjects with active cystic acne at screening (> 2 nodules or any cysts present at
Baseline).

2. Use of antibiotics 2-weeks prior to screening.

3. Use of retinoids 2-weeks prior to screening.

4. Use of salicylic acid or benzoyl peroxide 7 days prior to screening.

5. Excessive facial hair, skin conditions, facial tattoos, or other dermatologic marks
that would obscure the treatment area.

6. Use of Isotretinoin (Accutane) 6 months prior to screening.

7. Semi-permanent or permanent injection in the face 3 months prior to screening.

8. History of bleeding disorders.

9. Use of blood thinners (i.e warfarin (Coumadin), clopidogrel bisulfate (Plavix), etc.)
1 month prior to screening.

10. Acne scars that are considered post-inflammatory erythematous, post-inflammatory
hyperpigmentation, varicella (chicken pox) scars, or perifollicular elastolysis will
not be allowed to be identified as the target acne scars. These types of scars are
still allowed to be present but cannot be selected.

11. Acne scars that are located in the glabella and temple regions. Acne scars located in
these regions will not be allowed to be selected as a target or additional acne scar.
As well, scars located in these areas will not be allowed to be treated during the
study. Subjects are allowed to have acne scars located in these areas but cannot have
them selected for evaluation or treated during the study.

12. Laser or light (red and blue) treatments for acne 3 months prior to screening.

13. Resurfacing procedures (CO2 , Erbium, Fraxel, etc.) performed 6 months prior to
screening.

14. Any chemical peels in the last 30 days prior to screening.

15. Hypersensitivity to amid-type local anesthetics.

16. Any cortisol steroid or ILK injection 30 days prior to screening

17. Subjects with a history of diabetes.

18. Any medical condition or diagnosis which in the investigator's opinion would
disqualify them from the research study.

19. History of abuse with the use of alcohol or drugs.

20. Participation in a clinical trial or use of an investigational product in the past 30
days.

21. Subjects who are considered health risks for participation in the study or the
investigator determines not to be suitable.