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

NCT07286318 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: STUDY25050043
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

Niacinamide; Cutaneous squamous cell carcinoma; Basal cell carcinoma; Organ transplant recipient; Actinic keratosis

Outcome Measures

Primary Outcomes (1)

• Change in baseline AK count

  Change in actinic keratosis count at 6 and 12 months from baseline, measured by standardized assessment and clinical quantification

  Baseline, 6 months and 12 months

Secondary Outcomes (1)

• New NMSC

  6 months and 12 months

Study Arms (2)

Sunscreen Only

ACTIVE COMPARATOR

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.

Drug: Sunscreen

Sunscreen + Niacinamide

EXPERIMENTAL

In addition to using broad spectrum SPF 30 daily sunscreens, participants will apply topical 5% niacinamide daily to any sun exposed areas.

Drug: Topical niacinamide 5% cream; Drug: Sunscreen

Interventions

Topical niacinamide 5% cream DRUG

Participants will be instructed to apply topical 5% niacinamide daily to any sun exposed areas.

Sunscreen + Niacinamide

Sunscreen DRUG

Sunscreen application daily, broad spectrum SPF 30, to any sun exposed areas

Sunscreen + Niacinamide; Sunscreen Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 History of solid organ transplantation At least 5 AKs in the past year or prior history of skin cancer Participants are willing to continue using SPF30 sunscreen from their own supply

You may not qualify if:

• Known allergy to niacinamide or sunscreen components Eczema or other skin conditions for which niacinamide is contraindicated

Sponsors & Collaborators

• Marissa Lobl: lead

Study Sites (2)

UPMC Falk Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC St Margarets Dermatology

Pittsburgh, Pennsylvania, 15238, United States

Location

Related Publications (16)

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MeSH Terms

Conditions

Skin Neoplasms; Keratosis, Actinic; Carcinoma, Basal Cell

Interventions

Niacinamide; Sunscreening Agents

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Precancerous Conditions; Keratosis; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Central Study Contacts

Marissa Lobl, Resident Physician, Principal Investigator, MD, PhD

CONTACT

2244566009; loblm@Upmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: UPMC Dermatology Resident

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: It will be available when the study is complete and for 2 year or longer.
• Access Criteria: Those requesting IPD who have a data sharing agreement will be able to access the data. They must request an agreement to the study team.

Locations

US (2)