Zinc Oxide vs. Petrolatum for Scarring

Recruiting at 1 trial location

Overseen By Lauren Crow, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Lina Husienzad

Disqualifiers: Under 18, Asymmetric scar, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two ointments, zinc oxide and petrolatum, to determine which aids better scar healing after surgery. Individuals who have undergone surgery on non-scalp skin, with a scar at least 4.5 cm long, are eligible to join. Participants will apply each ointment to different halves of their scar and monitor their progress over a month. They will visit the clinic several times for scar assessments by dermatologists. Participants who complete the study will receive a skincare gift bag. As an Early Phase 1 trial, this research seeks to understand how these ointments work in people, offering participants a unique opportunity to contribute to early-stage medical research.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that zinc oxide is often used in wound care, such as in Unna Boot bandages for leg ulcers. These bandages help keep wounds moist, which can speed up healing. People generally tolerate zinc oxide well, and it is safe to use on the skin for up to seven days at a time.

Petrolatum, also known as petroleum jelly, is a popular skin moisturizer. It is very safe and often protects dry or cracked skin. Petrolatum should only be used externally.

Both zinc oxide and petrolatum have been safely used in skin care for a long time. Participants in this study are likely to tolerate both treatments well, given their common use and safety in wound and skin care. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatment options like silicone gels or sheets for scarring, zinc oxide offers a unique approach by leveraging its natural anti-inflammatory and antibacterial properties to promote healing. Petrolatum, a well-known barrier agent, is also being tested, but zinc oxide stands out for its potential to not only protect the wound but also actively reduce inflammation and bacterial growth. Researchers are excited about zinc oxide because it could provide a dual benefit of protection and enhanced healing, which is not as pronounced in other scarring treatments.

What evidence suggests that zinc oxide and petrolatum could be effective for scarring?

This trial will compare the effects of zinc oxide and petrolatum on scarring. Research has shown that zinc oxide can speed up wound healing and effectively reduce swelling in individuals with circulation issues, aiding quicker recovery. Studies on petrolatum, commonly known as petroleum jelly, indicate it is an excellent moisturizer and can enhance the appearance of scars. Specifically, after one week, 70% of participants using a scar product with petrolatum noticed significant improvements. Both zinc oxide and petrolatum offer promising benefits for treating scars but work in slightly different ways. Zinc oxide focuses on healing, while petrolatum maintains skin moisture and improves scar appearance. In this trial, surgical closures will be split, with zinc oxide ointment applied to one half and petrolatum ointment to the other, allowing for direct comparison of their effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Lauren Crow, MD

Principal Investigator

Resident Physician, PGY-3

Are You a Good Fit for This Trial?

This trial is for adults who've had routine skin surgery with a straight-line scar at least 4.5cm long on non-scalp areas. The surgical site must be symmetrical and not visibly infected. People under 18 or those allergic to topical zinc oxide, as well as those with grossly infected scars or visibly asymmetric scars, cannot participate.

Inclusion Criteria

My surgical site looks the same on both ends.

Linear closure, non-scalp site

My surgery scar is at least 4.5 cm long.

Exclusion Criteria

My surgical wound is severely infected.

You have a scar that looks noticeably uneven or lopsided.

You have had an allergic reaction to zinc oxide applied on the skin in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants apply zinc oxide and petrolatum ointments to each half of the scar daily for one month

4 weeks

1 visit (in-person) at 1 week post-op

Follow-up

Participants are monitored for scar assessment and safety at multiple intervals post-treatment

6 months

3 visits (in-person) at 4 weeks, 8 weeks, and 6 months post-op

Long-term Follow-up

Participants may submit electronic photographs if unable to attend the final visit

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Zinc Oxide vs. Petrolatum

Trial Overview

The study compares the effects of zinc oxide ointment versus petrolatum (a moisturizing agent) on post-surgical scarring. Participants will apply these treatments to different halves of their scar daily for a month and attend follow-up visits for photographic assessments and scoring using the Patient and Observer Scar Assessment Scale.

How Is the Trial Designed?

Group I: Single arm - split scar study Experimental Treatment 1 Intervention

Surgical closures, at least 4.5cm in length, will be split and zinc oxide ointment applied to half and petrolatum ointment to the other half

Zinc Oxide vs. Petrolatum is already approved in United States, European Union for the following indications:

Approved in United States as Zinc oxide for:

• Skin protection
• Wound healing
• Dermatitis prevention

Approved in European Union as Zinc oxide for:

• Skin protection
• Wound healing
• Dermatitis prevention

Who Is Running the Clinical Trial?

Lina Husienzad

Lead Sponsor

Trials

1

Recruited

30+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Melissa Pugliano-Mauro

Lead Sponsor

Trials

3

Recruited

90+

Lauren Crow

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study comparing two petrolatum-based ointments for postoperative wound care, Aquaphor Healing Ointment (AHO) caused a higher incidence of wound redness (52%) compared to plain white petroleum jelly (12%).

While both ointments are used to keep wounds moist and promote healing, AHO may lead to more noticeable wound reactivity, suggesting that the choice of ointment can impact postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative wound care after dermatologic procedures: a comparison of 2 commonly used petrolatum-based ointments. Morales-Burgos, A., Loosemore, MP., Goldberg, LH.[2013]

In a study involving 148 naval cadets, those wearing zinc oxide nanoparticle (ZnO-NP)-coated socks showed significantly less development of pitted keratolysis (PK) compared to those wearing uncoated socks, indicating the effectiveness of ZnO-NPs in preventing this skin condition.

While both groups reported reduced foot odor, the uncoated sock group experienced a greater negative impact on their daily lives due to foot odor, highlighting the potential benefits of ZnO-NP-coated socks for improving quality of life in military personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of zinc oxide nanoparticle-coated socks compared to uncoated socks for the prevention of pitted keratolysis: a double-blinded, randomized, controlled trial study. Ongsri, P., Leeyaphan, C., Limphoka, P., et al.[2021]

Zinc oxide (ZnO) nanoparticles used in sunscreens do not penetrate into the viable epidermis of the skin, regardless of the formulation used, ensuring a level of safety regarding deep skin absorption.

Topical application of ZnO leads to an increase in labile zinc ions in the outer skin layers, particularly at a pH of 6, which may enter systemic circulation but does not indicate harmful penetration into deeper skin layers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative Penetration of Zinc Oxide and Zinc Ions into Human Skin after Application of Different Zinc Oxide Formulations. Holmes, AM., Song, Z., Moghimi, HR., et al.[2016]

In a study involving six healthy subjects, applying 40% zinc oxide ointment resulted in a slight increase in serum zinc levels, but this change was not statistically significant, indicating minimal systemic absorption.

In a second phase with three patients on total parenteral nutrition, daily application of the ointment showed stable serum zinc levels over 10 days, further supporting that topical zinc oxide does not lead to significant absorption into the bloodstream.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study of the percutaneous absorption from topically applied zinc oxide ointment. Derry, JE., McLean, WM., Freeman, JB.[2017]

Topical application of 40% zinc oxide ointment significantly reduced clinical scar hypertrophy scores in a rabbit model of hypertrophic scars after 6 weeks, suggesting its potential effectiveness in preventing scar development.

While zinc oxide also showed a reduction in nodule formation histopathologically, this result was not statistically significant, indicating that while it may help, further research is needed to confirm its overall efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of topical zinc oxide application on hypertrophic scar development in rabbits. Aksoy, B., Atakan, N., Aksoy, HM., et al.[2013]

A new zinc oxide ointment (10% zinc oxide) was developed as a safer alternative to the traditional boric acid and zinc oxide ointment, maintaining similar consistency and clinical efficiency.

In a small study involving six patients with chronic eczema and seven with psoriasis vulgaris, the zinc oxide ointment demonstrated effective wound healing comparable to the original formulation, suggesting it could be a viable option for treating skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical studies on zinc oxide ointment replacing boric acid and zinc oxide ointment (JP8)]. Kubota, K., Kumakiri, M., Miura, Y., et al.[2013]

Zincojecol, an ointment containing both zinc oxide and cod liver oil, significantly enhances wound healing compared to ointments with no active ingredients or those containing only one of the components.

The combination of zinc oxide and cod liver oil was particularly effective in promoting epidermal proliferation and accelerating wound healing, especially in cases where healing was delayed by dexamethasone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of the zinc oxide and cod liver oil containing ointment Zincojecol in an animal model of wound healing]. Kietzmann, M., Braun, M.[2013]

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SAFETY DATA SHEET

Eye contact. : Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses.

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PETROLEUM SKIN PROTECTANT- white petrolatum jelly

Active ingredient. White petrolatum USP (100%) · Purpose. Skin protectant · Use. temporarily protects chapped or cracked skin · Warnings. For external use only · Do ...