None listed
Conditions
Brief summary
The purpose of this study is to test a drug called GDD3898 Topical Gel on participants with Sebaceous Hyperplasia. Sebaceous hyperplasia is a disorder in which sebaceous glands become enlarged, producing flesh-coloured or yellowish, papules on the face. Lesions of sebaceous hyperplasia do not resolve spontaneously and are resistant to a variety of treatments. They are subject to irritation with shaving and patients frequently complain about their appearance. Sebaceous hyperplasia occurs in 1-2% of the population. Current treatment options include, but are not limited to, the use of topical retinoids, electrocauterisation, photodynamic, laser, or cryotherapy, etc.; however there is currently no approved pharmacological treatments for Sebaceous Hyperplasia. Animal studies have shown that GDD3898 can decrease sebaceous gland size and inhibit cell growth, which may translate into therapeutic benefits in people with Sebaceous Hyperplasia. The main aims of this trial are: • To assess the effect of the study drug on Sebaceous Hyperplasia • To assess the safety and tolerability of the study drug
Interventions
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 t
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.
Sponsors
InClin Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed