A Phase 2 Safety and Efficacy Study of UHE-101 Cream in Subjects With Acne Vulgaris

The purpose of this study is to test a topical cream (UHE-101) containing 1.0% of active
drug, for 12 weeks, in boys and girls, men and women, in the treatment of facial acne.

Patients who qualify for this study will apply the study cream twice daily (once in the
morning and once in the evening) for 12 weeks.

Half of the patients in this study will receive UHE-101 cream and half will receive a vehicle
cream that does not include an active drug (i.e., placebo). This is a double-blind study,
which means that neither the patient nor the investigator will know which cream the patient
is using. The study will last about 12 weeks and will involve 5 clinic visits.

Inclusion Criteria:

1. Patient must provide written informed consent/assent. A patient under 18 years of age
must provide written informed assent and be accompanied by the parent or legal
guardian at the time of assent/consent signing. The parent or legal guardian must
provide informed consent for the patient. If a patient becomes 18 years of age during
the study, the patient must provide written informed consent at that time to continue
study participation.

2. Females must be post-menopausal, surgically sterile, or use an effective method of
birth control.

3. Patient has moderate to severe facial acne vulgaris.

4. Patient must be in good general health as determined by the investigator and supported
by medical history, physical and Vital Signs exam.

Exclusion Criteria:

1. Females who are pregnant, lactating, or are planning to become pregnant during the
study.

2. Patient has active nodulocystic acne or acne conglobate, acne fulminans, or other
forms of acne (e.g., acne mechanica).

3. Patient has any skin pathology or condition that, in the investigator's opinion, could
interfere with the evaluation of the test article or requires use of interfering
topical, systemic, or surgical therapy.

4. Patient has used any of the following topical anti-acne preparations or procedures on
the face:

- Topical anti-acne treatments including, but not limited to, over the-counter
(OTC) acne cleansers or treatments, benzoyl peroxide, antibiotics, azelaic acid,
dapsone, sulfa based products, corticosteroids, and salicylic acid within two
weeks of Baseline;

- Topical retinoids (e.g., tazarotene, adapalene, and tretinoin) within four weeks
of Baseline;

- Light treatments, microdermabrasion, or chemical peels within eight weeks of
Baseline;

- Other topical therapy, which may materially affect the patient's acne, in the
investigator's opinion.

5. Patient has used any of the following systemic anti-acne medications:

- Corticosteroids (including intramuscular and intralesional injections) within
four weeks of Baseline. Inhaled, intranasal, or ocular corticosteroids are
allowed if use is stable;

- Antibiotics or other systemic anti-acne medications within four weeks of
Baseline, with the exception of five days or less of antibiotic therapy during
this period, but not within one week of Baseline;

- Androgen receptor blockers (i.e., spironolactone or flutamide) within eight weeks
of Baseline; with the exception of five days or less of spironolactone therapy
during this period, but not within one week of Baseline;

- Retinoid therapy (e.g., isotretinoin) within six months of Baseline;

- Vitamin A supplements (greater than 10,000 units per day) within six months of
Baseline;

- Other systemic therapy, which may materially affect the patient's acne, in the
investigator's opinion.

6. Patient has the need or plans to be exposed to artificial tanning devices or excessive
sunlight during the study.

7. Patient has used an investigational drug or investigational device treatment within 30
days prior to first application of the test article or is currently enrolled in an
investigational drug, device, or biologic study.

8. Patient has a history of sensitivity to any of the ingredients in the test articles.