Plain English Summary
Background and study aims
Acne is an extremely common skin disease that is found most typically in adolescence and young adulthood. It causes spots, oily skin and sometimes skin that's hot or painful to touch. The aim of this study is to evaluate the effectiveness and acceptance of UP256 cream, 0.5% in the treatment of acne.
Who can participate?
People aged 12-30 with mild to moderate acne
What does the study involve?
Participants are required to follow instructions from the investigator and apply a cream to their face twice a day. The length of the study is 16 weeks and consists of a screening visit, baseline visit (week 0), and treatment visits at weeks 1, 2, 4, 6, 8, 10 and 12. The screening and baseline visit assessment will include an acne lesion count and the first application of the cream by the participant. Treatment visits will also include an evaluation of the response to treatment, a patient questionnaire, acne lesion count, safety assessment, collection of study medication and reporting of adverse events.
What are the possible benefits and risks of participating?
The study does not promise any benefit but a possible benefit could be a clearer complexion. The most common foreseeable adverse events include erythema (redness), irritation and peeling of the skin due to a known mild irritation quality of the topical antibiotics. A risk of participating in the study is that participants are not able to use other acne medication and their condition may worsen.
Where is the study run from?
SUNY Downstate Medical Center (USA)
When is the study starting and how long is it expected to run for?
March 2009 to June 2010
Who is funding the study?
Unigen Inc. (USA)
Who is the main contact?
Lidia Alfaro Brownell
lbrownell@unigen.net
Trial website
Contact information
Type
Scientific
Primary contact
Ms Lidia Alfaro Brownell
ORCID ID
http://orcid.org/0000-0002-5328-0152
Contact details
2121 South State Street Suite 400
Tacoma
98405
United States of America
+1 (0)253 274 7166
lbrownell@unigen.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
UN2008-256-01
Study information
Scientific title
A pilot, open-label study to evaluate the antimicrobial and anti-inflammatory properties of UP256 cream
Acronym
Study hypothesis
0.5% bakuchiol cream reduces total acne lesions when applied twice a day for a period of 12 weeks.
Ethics approval
Approved 06/04/2009, SUNY Downstate Medical Center Institutional Review Board (450 Clarkson Avenue Brooklyn, NY 11203, USA; +1 (0)718 270 2680; irb@downstate.edu), ref: 09-008
Study design
Single-center open-label interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not applicable
Condition
Acne and hyperpigmentation
Intervention
A cream containing 0.5% bakuchiol was applied to the face twice a day for a period of 12 weeks. The study was open-label and no control group or placebo was used. Participants that met the inclusion criteria were enrolled and assigned to the study product. The length of the study is 16 weeks and consists of a screening visit, baseline visit (week 0), and treatment visits at weeks 1, 2, 4, 6, 8, 10 and 12.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Acne inflammatory lesions and non-inflammatory lesions measured using lesion count at baseline and weeks 4, 8, and 12
2. Post-inflammatory hyperpigmentation caused by acne measured using physician assessment method at baseline and weeks 4, 8, and 12
Secondary outcome measures
Safety and tolerability of the cream measured by investigator assessment of erythema (redness), dryness, peeling and oiliness at baseline and weeks 1, 2, 4, 6, 8, 10 and 12
Overall trial start date
12/03/2009
Overall trial end date
30/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female
2. Moderate to mild acne
3. Age 12-30
4. Fitzpatrick Skin Type III and higher
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
15
Total final enrolment
17
Participant exclusion criteria
1. Not healthy
2. Severe acne
3. Recent use of acne treatment
Recruitment start date
17/04/2009
Recruitment end date
15/11/2009
Locations
Countries of recruitment
United States of America
Trial participating centre
SUNY Downstate Medical Center
450 Clarkson Avenue
Brooklyn, New York
11203-2098
United States of America
Sponsor information
Organisation
Unigen Inc.
Sponsor details
2121 South State Street
Suite 400
Tacoma
98405
United States of America
+1 (0)253 274 7166
lbrownell@unigen.net
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Unigen Inc.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To publish the study data in a dermatology journal.
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date. Currently data to be used for publication is saved as the analyzed file in an Excel format on a CD, the file is de-identified as per HIPAA Guidelines and stored in a limited access area at Unigen Inc.
Intention to publish date
01/09/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list