Condition category
Skin and Connective Tissue Diseases
Date applied
10/07/2020
Date assigned
11/09/2020
Last edited
11/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Publication citations

Additional files

Editorial Notes

28/07/2020: Trial's existence confirmed by Unigen Inc.