A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Evaluate the Safety and Efficacy of UHE-101 Cream 1% When Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

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



Sponsors

Lead Sponsor



Source

Therapeutics, Inc.

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


Brief Summary

UHE-101 cream, 1% ("UHE-101") is being developed for the topical treatment of acne vulgaris.
The purpose of this study is to compare the safety and efficacy of twice daily topical
application of UHE-101 cream for 12 weeks to its vehicle cream in subjects with facial acne
vulgaris.

Detailed Description

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.

Overall Status

Recruiting

Start Date

2017-10-05

Completion Date

2018-10-01

Primary Completion Date

2018-10-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Investigator's Global Assessment (IGA) "Success"
Week 12
Acne Lesion Counts (Absolute Change)
Week 12

Secondary Outcome

Measure

Time Frame

IGA "Success"
Week 4
IGA "Success"
Week 8
Acne Lesion Counts (Absolute Change)
Week 4
Acne Lesion Counts (Absolute Change)
Week 8
Acne Lesion Counts (Percent Change)
Week 4
Acne Lesion Counts (Percent Change)
Week 8
Acne Lesion Counts (Percent Change)
Week 12

Enrollment

48

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Topical cream containing investigational drug at a concentration of 1%

Arm Group Label

UHE-101 cream, 1%


Intervention Type

Other

Intervention Name


Description

Topical cream containing no drug (i.e., placebo)

Arm Group Label

Vehicle cream



Eligibility

Criteria

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.

Gender

All

Minimum Age

12 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Contact

Last Name

Jim Berg

Phone

858-571-1800

Email



Location

Facility

Status

Contact

Site 02
San Diego California 92123 United States
Recruiting
Phone: 858-571-6800

Location Countries

Country

United States


Verification Date

2017-10-01

Lastchanged Date

2017-10-10

Firstreceived Date

2017-10-05

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

UHE-101 cream, 1%

Arm Group Type

Experimental

Description

Cream is applied twice a day


Arm Group Label

Vehicle cream

Arm Group Type

Placebo Comparator

Description

Cream is applied twice a day



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

This is a double-blind study, which means that neither the patient nor the investigator will know which cream the patient is using.


Study First Submitted

October 5, 2017

Study First Submitted Qc

October 5, 2017

Study First Posted

October 11, 2017

Last Update Submitted

October 10, 2017

Last Update Submitted Qc

October 10, 2017

Last Update Posted

October 12, 2017


ClinicalTrials.gov processed this data on October 12, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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