Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000008729
Ethics application status
Approved
Date submitted
19/10/2021
Date registered
11/01/2022
Date last updated
28/01/2024
Date data sharing statement initially provided
11/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An Exploratory, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of GDD3898 Topical Gel in Subjects with Sebaceous Hyperplasia
Scientific title
An Exploratory, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of GDD3898 Topical Gel in Subjects with Sebaceous Hyperplasia
Secondary ID [1] 305209 0
GDD3898-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sebaceous Hyperplasia 323481 0
Condition category
Condition code
Skin 321042 321042 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study nurse will apply the first dose as an even layer of 1.75% GDD3898 Topical Gel in the clinic by rubbing in thoroughly with a Q-Tip or a gloved finger specifically to the designated lesions/treatment area(s) plus 1-2 mm of the surrounding normal skin twice a day for 12 weeks. The study nurse will provide training to the participant on gel application at this the initial visit and then the participant will apply the gel onto themselves at home using the same technique.

Study medication tubes will be weighed at each clinic visit. Additionally, participants will complete a daily diary recording the date and time of each dose applied, any missed doses, and a comment section should the subjects have a comment, e.g., recorded potential AEs.
Intervention code [1] 321609 0
Treatment: Drugs
Comparator / control treatment
A separate qualifying lesion, at least 5 cm from the first and if possible on the opposite side of the face will be identified as an untreated Reference Lesion (RL). The RL should be solitary lesions circumscribed by normal, non-lesional skin to facilitate accurate measurements and image analysis.
Control group
Active

Outcomes
Primary outcome [1] 328823 0
Primary Outcome - to assess the safety of GDD3898 Topical Gel, 1.75%, in subjects with Sebaceous Hyperplasia. Safety will be assessed by the following:
1. Vital signs including body temperature (measured using a forehead thermometer) , pulse rate (measured using a digital monitor), respiratory rate (measured using a digital monitor), blood pressure (measured using a digital monitor), height (measured using a wall mounted height measure) and weight (measured using digital scales). BMI will be calculated in the database using the participants height and weight. These results will be assessed during the physical examination and documented in the participants medical records.
2. Complete physical examination including complete dermatological examination.
3. Analysis of blood and urine samples including haematology, chemistry, drug screen and pregnancy test (for women of childbearing potential)
Timepoint [1] 328823 0
1. Vital signs will be collected at 12 and 6 weeks prior to first dose, Day 1, week 6 & 12 and optional follow up assessments at 16 and 20 weeks post-first dose (participant discretion).
2. Complete physical examination will be performed at 6 weeks prior to first dose, Day 1 and weeks 6 & 12.
3. Blood and urine samples will be collected at 6 weeks prior to first dose, Day 1 and week 12. A serum pregnancy test will also be collected for women of childbearing potential at 12 weeks prior to first dose.
Primary outcome [2] 329461 0
Primary Outcome - to assess the tolerability of GDD3898 Topical Gel, 1.75%, in subjects with Sebaceous Hyperplasia. Tolerability will be assessed by the following:
1. Irritation reactions at the application site will be graded using an assessment scale.
Timepoint [2] 329461 0
Application site reaction assessments will be performed at the day 1 visit and the week 3, 6 & 12 visit. They may also occur at the optional follow up assessments at 16 and 20 weeks post-first dose (participant discretion).
Secondary outcome [1] 400522 0
The primary assessment of efficacy for GDD3898 Topical Gel 1.75% in subjects with sebaceous hyperplasia will be assessed as a composite score by Canfield, who have designed specialist image capture hardware and image analysis software for skin conditions. The efficacy will be based on the following:
1. Investigator lesion assessment - measured diameter as well as visual and tactile assessment of each lesion within the treatment area.
2. Dermal Imaging - clinical photographs of the affected area will be compared prior to and after completion of 12 weeks of treatment. Lesions will be evaluated for size, colour, and telangiectasia.
3. Subject Response assessment - Subjects will assess their overall response to treatment at each study visits using the following scale:
Compared to before treatment, my treated sebaceous hyperplasia’s are:
• Worse
• The same
• Slightly better
• Much better
• Very much better or cleared
Timepoint [1] 400522 0
Primary efficacy assessment will be performed at the following timepoints:
1. Investigator lesion assessment will be performed at 12 and 6 weeks prior to first dose, Day 1, week 3, 6 & 12 and optional follow up assessments at 16 and 20 weeks post-first dose (participant discretion).
2.. Dermal imaging will be performed at 12 and 6 weeks prior to first dose, Day 1, week 3, 6 & 12 and optional follow up assessments at 16 and 20 weeks post-first dose (participant discretion).
2. Subject Response assessment will be performed at week 3, 6 & 12 and optional follow up assessments at 16 and 20 weeks post-first dose (participant discretion).

Eligibility
Key inclusion criteria

1. Subjects must have 2 or more stable, qualifying target lesions. One of the qualifying lesions must be suitable for treatment and assessments. The lesion should not be in close proximity to the eye and there should not be any other nearby lesion that might interfere with the photography or measurements and evaluations. A separate qualifying lesion, at least 5 cm from the first and if possible on the opposite side of the face, should be identified as an untreated Reference Lesion.
2. Subject agrees to photographic or other image capture methods of both the treated and untreated lesions.
3. Subject agrees to refrain from using all other sebaceous hyperplasia lesion removal products or treatments (i.e., topical medication including over-the-counter medications), or acne treatment products during the study period.
4. Subjects have had no facial procedures, including lasers, peels, and dermabrasion, on or around any Target or Reference Lesion within two (2) months prior to study start and agrees to refrain throughout the study.
5. Subject has no evidence of active infection in the designated lesion areas prior to treatment and reports no infection within prior 90 days.
6. Women of childbearing potential are required to use a protocol-approved highly effective contraceptive method for at least 4 weeks prior to Day 1 until at least 4 weeks after the last application.
7. Males with female partners of childbearing potential must use reliable forms of contraception from screening to 30 days after the end of treatment.
8. Subject is willing to refrain from washing the application site(s) for a minimum of 15 minutes before and 3 hours after each application of study drug.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject is a woman who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
2. Subject has a history of skin disease or presence of skin condition (e.g., atopic dermatitis, psoriasis, etc.) that, in the opinion of the Investigator, would interfere with the study assessments.
3. Subject is receiving systemic or topical medicated treatments for any facial condition, including but not limited to acne, rosacea, dermatitis, etc. Subject may not be receiving nor have taken isotretinoin or any other oral retinoid for 6 months prior to enrollment.
4. Subjects whose Target Lesion(s) reduce in size more than 10% during the Screening Period (from Day -84 to Day -42 or from Day -42 to Day 1) shall complete the Screening Period but may not be enrolled in active treatment on Day 1.
5. History or presence of concomitant liver diseases including hepatitis due to hepatitis B or C virus (HCV, HBV) infection, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), alcoholic liver disease, or autoimmune liver disease.
6. Subject with known history of or positive results for human immunodeficiency virus (HIV).
7. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening, or other substance abuse within the prior 2 years of Screening. A positive urine drug test during Screening or at Day 1 precludes the subject from receiving the experimental therapy. (Subjects with a positive urine drug test during screening may continue until Day 1 if approved to do so by the Investigator.)
8. Presence of scars, birthmarks, tattoos, or excessive hair at the application site(s) that would impede the assessment of local tolerability assessments.
9. Presence of facial piercing(s) near the Target and the Reference lesions.
10. Subject has a history of cancer or lymphoproliferative disease newly diagnosed, under active treatment, or with new recurrence within 3 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localised carcinoma in situ of the cervix are not to be excluded.
11. Subject has any clinically significant medical condition or physical/laboratory/vital signs abnormality that would, in the opinion of the Investigator, put the subject at undue risk by study participation or interfere with interpretation of study results.
12. Any screening laboratory evaluation outside the laboratory reference range, other than permitted by inclusion criteria, that is judged by the Investigator to be clinically significant.
13. Subject has a known or suspected allergy to GDD3898 or any component of the study drug.
14. Subjects who have major and/or clinically significant psychiatric disorders which would impede conduct of the research, including but not limited to, uncontrolled depression, suicidal ideation or uncontrolled bipolar disease at Screening.
15. Subject has any other known unstable medical condition that, in the opinion of the Investigator, puts the subject at undue risk or may limit the ability of the subject to comply with the protocol at Screening.
16. Subject has pyrexia, cough, malaise or any other symptoms or signs consistent with SARS-COV-2 viral infection at any time within 14 days prior to Screening or Baseline visits.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This open-label, exploratory study is intended to provide information on safety, local tolerability and preliminary proof of principle. It is not designed, powered or intended to establish statistically significant effects of treatment.
The primary assessments of efficacy will be the percentage of subjects with 1) complete or 2) partial clearing of Target Lesion using the Investigator lesion assessment grades of diameter and elevation at Weeks 12 (16) compared to Baseline. The secondary assessments of efficacy will be the changes in the area and volume of 1) the Target Lesion, and 2) all treated lesions collectively, determined by image analysis of photographs at Week 12 (16) compared to Baseline and 3) the changes in area and volume of the Target Lesion compared to the RL at Week 12 (16).
All adverse events will be coded using MedDRA (Medical Dictionary for Regulatory Activities) and assigned to the system organ class (SOC) and preferred term (PT). The number and percentage of subjects reporting adverse events (all, serious, related) will be tabulated. AEs will be summarised by SOC and PT. AEs will also be summarised by relationship to the study drug, leading to discontinuation or treatment modification, seriousness and severity.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/01/2022
Actual
31/01/2022
Date of last participant enrolment
Anticipated
21/03/2022
Actual
30/06/2022
Date of last data collection
Anticipated
8/08/2022
Actual
21/10/2022
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20506 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 35283 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 309591 0
Commercial sector/Industry
Name [1] 309591 0
Lipidio Pharmaceuticals Australia Pty Ltd.
Country [1] 309591 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
InClin Pty Ltd
Address
25-29 Berry Street, Level 2, Suite 210, North Sydney, New South Wales, 2060, Australia
Country
Australia
Secondary sponsor category [1] 310671 0
Commercial sector/Industry
Name [1] 310671 0
Lipidio Pharmaceuticals Australia Pty Ltd.
Address [1] 310671 0
58 Gipps Street
Collingwood, VIC 3066
Australia
Country [1] 310671 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309362 0
Bellberry HREC
Ethics committee address [1] 309362 0
Ethics committee country [1] 309362 0
Australia
Date submitted for ethics approval [1] 309362 0
01/09/2021
Approval date [1] 309362 0
15/10/2021
Ethics approval number [1] 309362 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113902 0
Dr Lynda Spelman
Address 113902 0
Veracity Clinical Research, Suite 18, Level 1, 250 Ipswich Road Woolloongabba, 4102 QLD
Country 113902 0
Australia
Phone 113902 0
+61738305514
Fax 113902 0
Email 113902 0
[email protected]
Contact person for public queries
Name 113903 0
Taylor Kilfoil
Address 113903 0
InClin Pty Ltd, 25-29 Berry Street, Level 2, Suite 210, North Sydney, New South Wales, 2060, Australia
Country 113903 0
Australia
Phone 113903 0
+61 408 880 403
Fax 113903 0
Email 113903 0
[email protected]
Contact person for scientific queries
Name 113904 0
Taylor Kilfoil
Address 113904 0
InClin Pty Ltd, 25-29 Berry Street, Level 2, Suite 210, North Sydney, New South Wales, 2060, Australia
Country 113904 0
Australia
Phone 113904 0
+61 408 880 403
Fax 113904 0
Email 113904 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be confidential


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.