Zinc Oxide vs. Petrolatum for Scarring
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byLina Husienzad, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Lina Husienzad
Disqualifiers: Under 18, Asymmetric scar, Infection, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
12346How 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.
12347Eligibility 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
+2 more
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.
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Single arm - split scar studyExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UPMC Dermatology St. MargaretPittsburgh, PA, PA
UPMC Dermatology St. MargaretPittsburgh, PA
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Who Is Running the Clinical Trial?
Lina HusienzadLead Sponsor
University of PittsburghLead Sponsor
Melissa Pugliano-MauroLead Sponsor
Lauren CrowLead Sponsor
References
Effectiveness of topical zinc oxide application on hypertrophic scar development in rabbits. [2013]The etiology, biology, prevention and effective treatment of hypertrophic scars have not exactly been defined. Topical zinc oxide application was shown to be effective in the treatment of proliferative scars. We studied the effectiveness of topical zinc oxide ointment in the prevention of hypertrophic scar development by using the rabbit ear hypertrophic scar model.
A study of the percutaneous absorption from topically applied zinc oxide ointment. [2017]The systemic absorption from topical applications of 40% zinc oxide ointment was investigated in a series of healthy subjects (phase one) and in patients receiving total parenteral nutrition (phase two). In the first phase, six subjects completed a controlled, cross-over trial involving 3 hourly serum sample determinations for zinc concentration following a massive application of 40% zinc oxide ointment and plain petrolatum ointment. There was a mean increase in serum zinc from 107.3 +/- 5.32 to 116.1 +/- 5.02 micrograms/dL 1 hr after application of 40% zinc oxide ointment (p greater than 0.05). Three patients receiving total parenteral nutrition completed phase two of the protocol in which 40% zinc oxide ointment was applied daily to a specified area of the thigh. Analysis of these patients' serum revealed that the zinc concentrations remained relatively constant over the 10-day study period. These findings suggest that topical applications of 40% zinc oxide ointment do not result in significant absorption. This study serves as a starting point for further investigations.
[Clinical studies on zinc oxide ointment replacing boric acid and zinc oxide ointment (JP8)]. [2013]A boric acid and zinc oxide ointment (J.P. VIII) is an unique preparation in Japan, which consist of boric acid (5%), zinc oxide (10%), vegetable oil (usually soybean oil or sesame oil) and yellow wax. The ointment is widely used in the area of Hokkaido, because not only of the customary prescription but also of the characteristic clinical efficiency. However, boric acid has been recognized to be harmful in these days. Therefore, a zinc oxide ointment consisting 10% zinc oxide, soybean oil and white beeswax was tentatively made and evaluated. The zinc oxide ointment presented the same consistency as the boric acid and zinc oxide ointment, measured with penetrometer. The clinical efficiency was also confirmed on six patients with chronic eczema and seven patients with psoriasis vulgaris. The effect on wound healing of the donor site of skin graft was as good as the previous preparation.
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]Pitted keratolysis (PK) and bromodosis have negative impacts on the quality of life especially for military personnel. The antibacterial efficacy and safety of zinc oxide nanoparticles (ZnO-NPs) make them a suitable additive for textiles. We aim to establish the ability of ZnO-NP-coated socks to prevent PK and bromodosis in a real-life setting.
[Effects of the zinc oxide and cod liver oil containing ointment Zincojecol in an animal model of wound healing]. [2013]The effects of Zincojecol an ointment containing zinc oxide and cod liver oil on wound healing were compared with ointments that either contained no active ingredients or zinc oxide or cod liver oil alone. All formulations enhanced the epidermal proliferation after mechanical irritation of the tail skin. The combination of zinc oxide and cod liver oil was found to be superior to the vehicle control and formulations containing only one active ingredient. This combination was also found to be most efficient in accelerating wound healing being retarded by repeated dexamethasone treatment.
Relative Penetration of Zinc Oxide and Zinc Ions into Human Skin after Application of Different Zinc Oxide Formulations. [2016]Zinc oxide (ZnO) is frequently used in commercial sunscreen formulations to deliver their broad range of UV protection properties. Concern has been raised about the extent to which these ZnO particles (both micronized and nanoparticulate) penetrate the skin and their resultant toxicity. This work has explored the human epidermal skin penetration of zinc oxide and its labile zinc ion dissolution product that may potentially be formed after application of ZnO nanoparticles to human epidermis. Three ZnO nanoparticle formulations were used: a suspension in the oil, capric caprylic triglycerides (CCT), the base formulation commonly used in commercially available sunscreen products; an aqueous ZnO suspension at pH 6, similar to the natural skin surface pH; and an aqueous ZnO suspension at pH 9, a pH at which ZnO is stable and there is minimal pH-induced impairment of epidermal integrity. In each case, the ZnO in the formulations did not penetrate into the intact viable epidermis for any of the formulations but was associated with an enhanced increase in zinc ion fluorescence signal in both the stratum corneum and the viable epidermis. The highest labile zinc fluorescence was found for the ZnO suspension at pH 6. It is concluded that, while topically applied ZnO does not penetrate into the viable epidermis, these applications are associated with hydrolysis of ZnO on the skin surface, leading to an increase in zinc ion levels in the stratum corneum, thence in the viable epidermis and subsequently in the systemic circulation and the urine.
Postoperative wound care after dermatologic procedures: a comparison of 2 commonly used petrolatum-based ointments. [2013]An appropriate selection of topical agents for wound care is important to promote uncomplicated healing. Petrolatum-based ointments, such as Aquaphor Healing Ointment (AHO) and white petroleum jelly, are commonly employed to keep wounds moist postoperatively. While they have beneficial properties for wound healing, they also may cause wound redness and swelling. We decided to evaluate for wound reactivity postoperatively for these 2 commonly used petrolatum-based ointments. We found that surgical wounds treated with AHO had a higher incidence of wound redness (52%) than those treated with plain white petrolatum (12%).