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

Trial Summary

What is the purpose of this trial?

Patients undergoing routine surgery in the Department of Dermatology for any indication on non-scalp skin and closed in linear fashion with scar greater than or equal to 4.5cm in length will be invited to participate in this split scar, head to head study comparing zinc oxide and petrolatum. Patients will apply respective ointments to each half of scar daily for one month and maintain a log of these activities. They will be seen at 1 week, 4 weeks, 8 weeks, and 6 months post-operatively for photographic scar assessment and to complete the patient portion of the Patient and Observer Scar Assessment Scale (POSAS), a quantitative objective assessment of scar appearance. Trained observers (board-certified dermatologists) will score the observer portion of the scale. POSAS outcomes, post-operative infections, linear density of epidermal seal will be assessed at the 1 week, 4 weeks, 8 weeks, and 6 months post-operative periods and compared between the two groups. Participants will have parking validated for all visits and upon completion of all portions of the study will receive a standardized skin care gift bag containing samples for hypoallergenic skin care products (washes, moisturizers, etc.).

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.

What data supports the effectiveness of the treatment Zinc Oxide vs. Petrolatum for scarring?

Research shows that zinc oxide can help prevent and treat scars, as seen in studies with rabbits and in wound healing. It has also been effective in treating skin conditions like eczema and psoriasis, suggesting it may help with scarring too. ^{1 2 3 4 5}

Is zinc oxide ointment safe for use in humans?

Research shows that zinc oxide ointment is generally safe for use in humans, as it does not significantly absorb into the body when applied to the skin. Studies have also shown its safety in various applications, such as in socks for preventing foot conditions and in ointments for skin conditions like eczema and psoriasis. ^{1 2 3 4 6}

How does the treatment of zinc oxide differ from other treatments for scarring?

Zinc oxide ointment is unique because it has been shown to be effective in preventing hypertrophic scars (raised scars) and does not significantly absorb into the body, making it a safe topical option. Unlike some petrolatum-based ointments, zinc oxide does not cause as much redness or swelling, which can be beneficial for wound healing. ^{1 2 3 4 7}

Research Team

Lauren Crow, MD

Principal Investigator

Resident Physician, PGY-3

Eligibility Criteria

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

I am 18 years old or older.

My surgical site looks the same on both ends.

Linear closure, non-scalp site

Exclusion Criteria

My surgical wound is severely infected.

You have a scar that looks noticeably uneven or lopsided.

I am 18 years old or younger.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of topical zinc oxide application on hypertrophic scar development in rabbits. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

A study of the percutaneous absorption from topically applied zinc oxide ointment. [2017]

3. Japan pubmed.ncbi.nlm.nih.gov

[Clinical studies on zinc oxide ointment replacing boric acid and zinc oxide ointment (JP8)]. [2013]

4. England 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. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Relative Penetration of Zinc Oxide and Zinc Ions into Human Skin after Application of Different Zinc Oxide Formulations. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Postoperative wound care after dermatologic procedures: a comparison of 2 commonly used petrolatum-based ointments. [2013]