A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant Recipients

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Marissa Lobl
Study ID
NCT07286318
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Actinic Keratosis (AK)
  • Cutaneous Squamous Cell Carcinoma (CSCC)
  • Organ Transplant Recipient
  • Skin Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Topical niacinamide 5% cream — DRUG
    Participants will be instructed to apply topical 5% niacinamide daily to any sun exposed areas.
  • Sunscreen — DRUG
    Sunscreen application daily, broad spectrum SPF 30, to any sun exposed areas

Study Details

A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Organ Transplant Recipients This study is designed to evaluate whether a topical 5% niacinamide cream can help prevent skin cancer in organ transplant recipients. Individuals who have received an organ transplant have a much higher risk of developing precancerous skin growths and skin cancers because of long-term immune-suppressing medications. Although sunscreen is an important part of sun protection, additional preventive approaches are needed. Early research suggests that niacinamide may help protect the skin, and this trial will examine whether a topical formulation provides benefit in this high-risk group. The study will test whether daily use of topical 5% niacinamide reduces the number of actinic keratoses over 6 and 12 months and whether it decreases the development of new keratinocyte cancers when compared with sunscreen alone. The study will also evaluate how well the topical product is tolerated and whether it can be used consistently as part of a daily skin-care routine. A total of 20 adult organ transplant recipients with a history of multiple actinic keratoses and at least one prior non-melanoma skin cancer will enroll in this 12-month, randomized, controlled trial. Participants will be assigned to receive either daily topical 5% niacinamide plus sunscreen or sunscreen alone. Skin examinations will be performed at 6 and 12 months using standardized mapping methods. Information on treatment tolerability, adherence, and any side effects will be collected through structured surveys, and any lesions suspicious for cancer will be evaluated by a board-certified pathologist.

Key Dates

Start date
May 1, 2026
Status verified
Jun 2026
Primary completion
May 28, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Sunscreen Only
    The participants will not be assigned to any intervention. They will use broad spectrum SPF 30 daily sunscreen as instructed regardless of whether or not they are enrolled in the study.
  • Experimental: Sunscreen + Niacinamide
    In addition to using broad spectrum SPF 30 daily sunscreens, participants will apply topical 5% niacinamide daily to any sun exposed areas.

Primary Outcome Measure

Change in baseline AK count [ Time Frame: Baseline, 6 months and 12 months ]

Central Contacts

  • Marissa Lobl, Resident Physician, Principal Investigator, MD, PhD
    2244566009
    [email protected]

Locations (2)

FacilityCityStateZIPSite coordinators
UPMC Falk DermatologyPittsburghPennsylvania15213
Marissa Lobl, MD, PhD
[email protected]
412-647-4200
Melissa Pugliano-Mauro, MD
UPMC St Margarets DermatologyPittsburghPennsylvania15238
Marissa Lobl, MD, PhD
[email protected]
(412) 784-7350
Melissa Pugliano-Mauro, MD (SUB_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
UPMC Falk Dermatology· Pittsburgh, PAUPMC St Margarets Dermatology· Pittsburgh, PA

Related Studies