A study to evaluate a facial cream containing 0.5% bakuchiol on subjects with acne
| ISRCTN | ISRCTN13992386 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13992386 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | UN2008-256-01 |
| Sponsor | Unigen Inc. |
| Funder | Unigen Inc. |
- Submission date
- 10/07/2020
- Registration date
- 11/09/2020
- Last edited
- 09/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Scientific
2121 South State Street Suite 400
Tacoma
98405
United States of America
 ORCID ID |
0000-0002-5328-0152 |
|---|---|
| Phone | +1 (0)253 274 7166 |
| lbrownell@unigen.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center open-label interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A pilot, open-label study to evaluate the antimicrobial and anti-inflammatory properties of UP256 cream |
| Study objectives | 0.5% bakuchiol cream reduces total acne lesions when applied twice a day for a period of 12 weeks. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Acne inflammatory lesions and non-inflammatory lesions measured using lesion count at baseline and weeks 4, 8, and 12 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 15 |
| Total final enrolment | 17 |
| Key inclusion criteria | 1. Male or female 2. Moderate to mild acne 3. Age 12-30 4. Fitzpatrick Skin Type III and higher |
| Key exclusion criteria | 1. Not healthy 2. Severe acne 3. Recent use of acne treatment |
| Date of first enrolment | 17/04/2009 |
| Date of final enrolment | 15/11/2009 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Brooklyn, New York
11203-2098
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2021 | 09/03/2021 | Yes | No |
| Basic results | 11/09/2020 | 08/10/2020 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN13992386_BasicResults_11Sep20.pdf
- Uploaded 08/10/2020
Editorial Notes
09/03/2021: Publication reference added.
08/10/2020: The basic results of this trial have been uploaded as an additional file.
28/07/2020: Trial's existence confirmed by Unigen Inc.
