30 Participants Needed

Zinc Oxide vs. Petrolatum for Scarring

Recruiting at 1 trial location
LH
LC
Overseen ByLauren Crow, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Lina Husienzad
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.13456

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.13457

Who Is on the Research Team?

LC

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.
See 1 more

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?
1Treatment groups
Experimental Treatment
Group I: Single arm - split scar studyExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Zinc oxide for:
🇪🇺
Approved in European Union as Zinc oxide for:

Find a Clinic Near You

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

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

Citations

Effectiveness of topical zinc oxide application on hypertrophic scar development in rabbits. [2013]
A study of the percutaneous absorption from topically applied zinc oxide ointment. [2017]
[Clinical studies on zinc oxide ointment replacing boric acid and zinc oxide ointment (JP8)]. [2013]
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]
[Effects of the zinc oxide and cod liver oil containing ointment Zincojecol in an animal model of wound healing]. [2013]
Relative Penetration of Zinc Oxide and Zinc Ions into Human Skin after Application of Different Zinc Oxide Formulations. [2016]
Postoperative wound care after dermatologic procedures: a comparison of 2 commonly used petrolatum-based ointments. [2013]
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