Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia (NCT06840470) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia
United States40 participantsStarted 2025-03-11
Plain-language summary
This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient has sebaceous hyperplasia lesions on both sides of the face. At least one sebaceous hyperplasia lesion on each side of the face is 1 mm or more in size.
* If of child-bearing potential, subject agrees to the use of highly effective contraception during study participation. For women of childbearing potential, acceptable pregnancy prevention measures will include abstinence, barrier methods, chemical methods, or surgical.
* Ability to understand and willingness to sign a written informed consent
Exclusion Criteria:
* Current use or prior use of a retinoid (e.g. tretinoin) within the last 4 weeks.
* Prior use of imiquimod on the treated area.
* Concurrent use of 5-fluorouracil, aminolevulinic acid (photodynamic therapy), or psoralen therapy, or use of any of these within the last 4 weeks.
* Concurrent facial peels or cosmetic laser therapy on the treated areas.
* Nursing, pregnant or planning to become pregnant.
* Immunocompromised status (e.g. organ transplantation recipients or patients on cyclosporine).
* Current participation in other investigational trials.
* Known or suspected history of a clinically significant systemic disease (e.g., immunological deficiencies), unstable medical disorders (e.g., unstable diabetes), life-threatening disease or current malignancies.
* Known hypersensitivity to any of the following (in any dosage form): imiquimod or any component of the study medications.
* Received radiation therapy and/or anti-neoplastic …
What they're measuring
1
Complete and 75% clearance rates (clearance refers to reduction in total lesional area) at 16 weeks of treated lesions