Aquaphor Healing Ointment

The petrolatum-based Aquaphor Healing Ointment is a an effective skin protectant and moisturizer that soothes chapped, irritated skin. It is used as standard therapy by many physicians for post-operative wound care.

Images


Effects


Grade Level of Evidence
A Double-blind, controlled study with more than 50 participants.
B Controlled study that is single-blind or has less than 50 participants.
C Controlled or comparative study.
D Uncontrolled or observational study.
Grade Effect Size of Effect Comments

C

Dermatitis treatment

Moderate

Improves mild-to-moderate atopic dermatitis and helps prevent dermatitis caused by radiation therapy.

C

Healing

Moderate

Improves erythema, edema, epithelial confluence, scabbing and crusting following skin surgery or laser resurfacing.

D

Less visible scars

Mild

Appears to be as effective as an onion extract gel (Mederma) in improving the cosmetic appearance of surgical scars.

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Ingredients


Petrolatum, Mineral Oil, Ceresin, Lanolin Alcohol, Panthenol, Glycerin, Bisabolol
NAME ANTIOXIDANT UV PROTECTION COMEDOGENIC IRRITANT SAFETY
PETROLATUM (ANTISTATIC, EMOLLIENT) NO DATA NO DATA RESTRICTED (SOURCE)
PARAFFINUM LIQUIDUM (ANTISTATIC, EMOLLIENT, SKIN PROTECTING, SOLVENT) NO DATA NO DATA ALLOWED (SOURCE)
CERESIN (ANTISTATIC, BINDING, EMULSION STABILISING, HAIR CONDITIONING, OPACIFYING, VISCOSITY CONTROLLING) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
LANOLIN ALCOHOL (ANTISTATIC, BINDING, EMOLLIENT, EMULSIFYING, HAIR CONDITIONING, VISCOSITY CONTROLLING) 2 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
PANTHENOL (ANTISTATIC, HAIR CONDITIONING, SKIN CONDITIONING) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
GLYCERIN (DENATURANT, HUMECTANT, PERFUMING, SOLVENT) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
BISABOLOL (MASKING, SKIN CONDITIONING, SOOTHING) NO DATA NO DATA ALLOWED (SOURCE)

Clinical Studies


Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: single-blind randomized phase III clinical trial.

Products

RadiaPlex

Aquaphor

Trial Design

Prospective, randomized, single-blind, controlled

Duration

Products were applied every day from one day before the start of radiotherapy to the end of the radiation treatments, or the development of grade 3 or 4 skin toxicity.

Subjects

74 female breast cancer patients who had undergone lumpectomy and were to receive whole-breast radiation therapy

Regimen

Patients applied a thin layer of RadiaPlex on half of the irradiated breast, and Aquaphor to the other half, 3 times a day.

Methods of Assessment

Physician assessment of radiation dermatitis according to a modified grading scale based on the NCI Common Terminology Crtieria for Adverse Events (CTCAE) version 3.0

Side Effects

None reported

Conflicts of Interest

MPM Medical, the manufacturer of the RadiaPlex Topical Gel, provided a small grant for the study as well as the study gels.

Effects observed in this study:

40 of the evaluable patients (61%) had radiation dermatitis that was equal or more severe than grade 2 with the RadiaPlex gel, compared to 32 patients (49%) with the Aquaphor ointment.

12 patients (16%) had dermatitis that was as or more severe than grade 2 with RadiaPlex and dermatitis that was less severe than grade 2 with Aquaphor; conversely, only 2 patients (3%) had grade 2 or worse radiation dermatitis with Aquaphor and less than grade 2 dermatitis with RadiaPlex.

Statistically, irradidated skin treated with RadiaPlex had more severe dermatitis than areas treated with Aquaphor.

An over-the-counter moisturizer is as clinically effective as, and more cost-effective than, prescription barrier creams in the treatment of children with mild-to-moderate atopic dermatitis: a randomized, controlled trial.

Products

Aquaphor Healing Ointment

Atopiclair

Epiceram

Trial Design

Randomized, comparative, double-blind

Duration

3 weeks of treatment

Subjects

39 patients aged 2-17 years, with mild to moderate atopic dermatitis

Regimen

Subjects were randomized to receive 1 of the 3 treatments, which they then applied 3 times daily.

Methods of Assessment

Investigators Global Assessment (IGA) severity scale

Overall body surface area (BSA) involvement

Investigators' Global Assessment of Improvement (IGAI)

Eczema Severity Index (EASI)

Visual Analog Scale (VAS) for itch intensity

Side Effects

1 subject from the Aquaphor group terminated the study early due to disease flaring. No serious adverse events were reported.

Conflicts of Interest

None declared

Effects observed in this study:

The Aquaphor group was the only group to demonstrate statistically significant improvement in all assessments by the end of the study. However, none of these measures reached a statistically significant difference between groups.

Because Aquaphor is markedly cheaper compared to Atopiclair and Epiceram, it was found to be 47 times more cost-effective. Based on the cost per improvement in EASI score, Aquaphor's cost-efficacy was $0.05, whereas Atopiclair and Epiceram had similar cost-efficacies of $2.82 and $2.35 respectively.

A comparative trial comparing the efficacy of tacrolimus 0.1% ointment with Aquaphor ointment for the treatment of keratosis pilaris.

Products

Tacrolimus Ointment (0.1%)

Aquaphor

Trial Design

Double-blind, comparative

Duration

4 weeks of treatment

Subjects

30 patients aged 2-16 who had keratosis pilaris

Regimen

Patients applied Aquaphor or tacrolimus to the lateral aspect of a right limb and the other treatment to the left limb, twice a day.

Methods of Assessment

Investigator's Global Assessment Score evaluating hyperkeratosis, erythema, follicular prominence, papules, and pustules on a 3-point scale.

Quality of Life (QOL) questionnaire for patients

Side Effects

Mild and transient side effects including minor itching (26% of tacrolimus-treated limbs and 15% of Aquaphor-treated limbs) and a burning sensation (15% of tacrolimus-treated limbs and 4% of Aquaphor-treated limbs).

Conflicts of Interest

None declared.

Effects observed in this study:

Both treatments led to statistically significant improvements in overall condition relative to baseline scores. Tacrolimus was more likely to lead to marked improvement. 6 limbs (22%) using tacrolimus achieved 75% or greater improvement, whereas only 1 limb using Aquaphor achieved a similar extent of improvement. However, this finding was not statistically significant.

All patients felt that their condition improved during therapy, and would use the treatments again.

Treatment of minor wounds from dermatologic procedures: a comparison of three topical wound care ointments using a laser wound model.

Products

Aquaphor Healing Ointment

Neosporin

Polysporin

Trial Design

Double-blind, randomized, comparative

Duration

18 days of treatment

Subjects

20 men and women aged 25-50 with Fitzpatrick skin type I, II or III

Regimen

4 erbium/ carbon dioxide laser wounds penetrating to the dermis were made in each participant. Subjects then applied Aquaphor Healing Ointment, Neosporin or Polysporin to each of 3 wound sites, leaving 1 site untreated. Wounds were covered with gauze, cleaned once daily with a cleanser, and treatments were applied 3 times daily.

Methods of Assessment

Clinical grading of erythema, edema, epithelial confluence, crusting and scabbing using a 5-point analog scale

Investigator and subject self-evaluations of general wound appearance on a 5-point scale

Transepidermal water loss using a DermaLab

Digital photographs of each subject's forearm

Side Effects

Minimal burning, stinging, itching, tightness, tingling and pain. No incidences of infection or allergic contact dermatits were noted.

Conflicts of Interest

None declared.

Effects observed in this study:

There were significant improvements in erythema, edema and epithelial confluence after treatment with Aquaphor Healing Ointment compared with Neosporin and Polysporin. No statistical differences were observed between Neosporin and Polysporin for any clinical parameters.

Moreover, the average change in transepidermal water loss (TEWL) was significantly less with Aquaphor than with the other treatments between day 0 and day 4, indicating a greater recovering of the skin barrier. This difference was abolished at later time points.

At the end of the study, investigator grading of general wound appearance were also significantly higher for Aquaphor-treated wounds, and subjects' ranking of the sites based on wound appearance led to statistically superior scores for Aquaphor as well.

Postprocedural wound-healing efficacy following removal of dermatosis papulosa nigra lesions in an African American population: a comparison of a skin protectant ointment and a topical antibiotic.

Products

Aquaphor Healing Ointment

Polysporin

Trial Design

Double-blind, split-face, randomized, comparative, single-center

Duration

21 days of treatment

Subjects

20 African-American men and women of Fitzpatrick skin type IV, V or VI, and with dermatosis papulosa nigra.

Regimen

After the removal of 2 similar papules on each side of the face, wounds were cleansed twice daily with a gentle liquid cleanser and water, followed by application of Aquaphor or Polysporin to opposite sides of the face.

Methods of Assessment

Evaluations of erythema, edema, crusting, scabbing, epithelial confluence, melanin confluence and general wound appearance on a 5-point scale

Side Effects

No infections occurred, but 8 subjects experienced mild or moderate postinflammatory hyperpigmentation.

Conflicts of Interest

Publication of this study was supported by Beiersdorf, which owns the Aquaphor brand, and 1 of the 3 authors has served on the advisory boards of an been a study investigator for Beiersdorf and Johnson & Johnson.

Effects observed in this study:

No significant differences were observed between Aquaphor and Polysporin for the clinical grading parameters at any time point. 8 patients exhibited mild post-inflammatory hyperpigmentation and 3 patients exhibited moderate postinflammatory hyperpigmentation, but there was again no significant difference between treatments.

Likewise, the investigators' grading of general wound appearance did not differ between the 2 agents throughout the study. There was a favourable trend towards Aquaphor in the patients' self-assessments of wound appearance, but this was not statistically significant.

A comparison of postprocedural wound care treatments: do antibiotic-based ointments improve outcomes?

Products

Aquaphor Healing Ointment

Polysporin

Trial Design

Double-blind, randomized, multicenter, comparative

Duration

4 weeks of treatment

Subjects

30 Caucasian men and women with Fitzpatrick skin types I, II or III and 2 seborrheic keratoses 6-10 mm in size located on opposite sides of the front of their chest or abdomen

Regimen

After the seborrheic keratoses were removed, Aquaphor or Polysporin were applied twice daily to the lesion wounds.

Methods of Assessment

Clinical grading of erythema, edema, epithelial confluence, crusting, scabbing and general wound appearance using a 5-point analog scale

Digital photographs taken immediately before and after wounding and on days 7, 14 and 28.

Transepidermal water loss measurements on days 14 and 28 using a DermaLab system.

Subjects' daily rankings of wound sites based on which wound appeared more healed.

Side Effects

Slight burning, stinging, itching, tightness, tingling and pain were reported. There was one incident of allergic contact dermatitis in a Polysporin-treated wound.

Conflicts of Interest

Publication of this study was supported by Beiersdorf, which owns the Aquaphor brand, and 1 of the 3 authors has been a consultant for Beiersdorf.

Effects observed in this study:

Wound healing progressed similarly over time for the 2 treatments, as assessed by general wound appearance. TEWL measurements were numerically higher for Aquaphor at weeks 2 and 4, but the differences were not statistically significant. There were also no significant differences in the daily ranking scores for both products, or in the number of subjects who chose Aquaphor-treated sites versus those who chose Polysporin-treated sites as better healed at the end of the study.

Onion extract gel versus petrolatum emollient on new surgical scars: prospective double-blinded study.

Products

Aquaphor

Mederma

Trial Design

Prospective, randomized, double-blind, comparative, split-scar

Duration

8 weeks of treatment, with an additional evaluation at 12 weeks following the start of treatment and a follow-up phone interview at least 11 months post-operatively.

Subjects

24 men and women with new surgical wounds at least 4 cm in length, who had recently undergone Mohs or excisional surgery

Regimen

Each scar was divided into 2 equal parts, and each half was randomly assigned treatment with Mederma or Aquaphor. Patients applied the products 3 times a day from the day of suture removal.

Methods of Assessment

Physician evaluations of scars using a visual analog scale, and whether the overall cosmetic appearance of 1 half was better than the other.

Side Effects

No allergic reactions were reported.

Conflicts of Interest

None of the authors had conflicts of interest. The Mederma gel was provided by Metz Pharmaceuticals.

Effects observed in this study:

After 2 weeks, 8 (33%) of the Mederma-treated scar halves and 5 (21%) of the Aquaphor-treated scar halves were judged to be better in overall cosmetic appearance. At 8 weeks, this was reduced to 6 (27%) of the Mederma-treated scar halves and 4 (18%) of the Aquaphor-treated scar halves. By 12 weeks, no differences were found in overall cosmetic appearance between the scar halves in 12 (86%) of the cases, and there was only 1 (7%) case each were one treatment was found to be superior. Overall, the differences were not statistically significant.

Of the 21 patients who were successfully reached for a phone interview at an average of 16 months post-surgery, 19 reported no difference between the 2 scar halves in terms of overall cosmetic appearance, and 2 reported that the Aquaphor-treated half was better.

The effect of a mucopolysaccharide-cartilage complex healing ointment on Er:YAG laser resurfaced facial skin.

Products

Catrix 10 Ointment

Aquaphor

Trial Design

Comparative

Duration

8 days of treatment

Subjects

19 subjects aged 39 to 77 years who were undergoing laser resurfacing for rhytides or acne scarring

Regimen

Postoperatively, Aquaphor was applied to half of the patients' faces and Catrix 10 Ointment was applied to the other half. The ointments were applied every 2 hours for the first 24 hours, then every 4 hours following a 15-minute cool saline soak, until re-epithelialization was complete.

Methods of Assessment

Evaluation of erythema, edema and erosion of laser-treated areas using a 4-point scale

Comparison of digital photographs

Side Effects

None reported.

Conflicts of Interest

None declared.

Effects observed in this study:

The Clarix 10 Ointment led to daily mean severity scores for erythema, edema and erosion that were consistently lower than those of Aquaphor, and its overall efficacy index was statistically superior for all 3 variables.

It was suggested that the mucopolysaccharide-cartilage complex in the Clarix 10 ointment may have aided the migration of fibroblasts during re-epithelialization by providing a connective tissue matrix, and also that the complex may possess immunoaugmenting properties, acting to stimulate growth factors and increase the local immune response.

The effects of topical vitamin E on the cosmetic appearance of scars.

Products

Aquaphor

Aquaphor mixed with vitamin E

Trial Design

Double-blind, randomized

Duration

4 weeks of treatment, with the last assessment after an additional 8 weeks

Subjects

15 patients who had undergone skin cancer removal surgery

Regimen

Patients applied Aquaphor to one part of their scars, and Aquaphor + vitamin E to the other part twice daily

Methods of Assessment

Physician and patient evaluations of the cosmetic appearance of the scars

Opinions of a third blinded investigator given the photographs of the outcomes

Side Effects

3 patients terminated their involvement in the study within 48 hours due irritation and redness on the vitamin E-treated side. 5 of the remaining patients developed a pruritic, erythematous eruption on the vitamin E-treated side, of which 1 dropped out of the study.

Conflicts of Interest

None declared.

Effects observed in this study:

At the end of the study, 70% of the patients felt that there was no difference between the 2 treatments. The physicians judged that in 60% of cases there was no difference, and in 30% of the cases the Aquaphor-treated side was better. Hence, the researchers concluded that topical vitamin E had either no effect or worsened the cosmetic appearance of scars. Moreover, as 33% of the subjects developed contact dermatitis to the vitamin E, they felt that the use of topical vitamin E on surgical wounds should be discouraged.

Mohs surgeons' use of topical emollients in postoperative wound care.

Products

Aquaphor

Results / Report

An anonymous 10-question survey on postoperative emollient use for clean surgical wounds was emailed to 857 members of the American Collage of Mohs Surgery, of which 294 members responded. The most commonly used topical emollient was petrolatum (53.1%), followed by Aquaphor (19.4%) and bacitracin (8.2%). The surgeons also recommended that patients use petrolatum (69.4%), Aquaphor (38.4%), bacitracin (10%), mupirocin (9.2%), polymyxin (8.8%), neomycin (2%) or gentamicin (1%) at home to keep the wound moist.

Compositae-associated allergic contact dermatitis from bisabolol.

Products

Aquaphor Healing Ointment

Results / Report

The patch test results of 7 children, 6 of whom had atopic dermatitis, were reviewed. They had been patch-tested with Aquaphor Healing Ointment and its components provided by Beidersdorf. 4 had positive reactions to the moisturizer and the compound bisabolol.

Bisabolol may be a potential cause of allergic contact dermatitis in children with atopic dermatitis and a history of intolerance to Aquaphor Healing Ointment.

The lanolin paradox revisited.

Products

Aquaphor Healing Ointment

Results / Report

2 dermatologists had recently begun testing children who had a history of burning or irritation to Aquaphor Healing Ointment to a panel of its 8 individual product ingredients. They observed that 2 patients had negative reactions to commercially prepared lanolin such as that in Allergeaze, but positive reactions to the lanolin 30% in petrolatum in Aquaphor Healing Ointment. They therefore highlighted the need to test patients' personal products in addition to manufacturer's ingredients because of the potential of false-negative reactions to lanolin.

Irritation and allergy patch test analysis of topical treatments commonly used in wound care: evaluation on normal and compromised skin.

Products

Aquaphor Healing Ointment

Biafine Topical Emulsion

Neosporin

Polysporin

Bacitracin

Results / Report

Cumulative irritation testing in 108 subjects classified Aquaphor Healing Ointment, bacitracin, Neosporin and Polysporin as "mild", and Biafine Topical Emulsion as "probably mild". A 48-hour exaggerated irritation patch study found that clinical grading scores were significantly higher for Biafine Topical Emulsion and Neosporin than Aquaphor Healing Ointment at 72 hours. Transepidermal water loss and colorimeter a∗ values were also significantly lower for Aquaphor Healing Ointment and bacitracin compared with Biafine Topical Emulsion. None of the products induced allergic contact dermatitis.

Reactions to Aquaphor: is bisabolol the culprit?

Products

Aquaphor Healing Ointment

Results / Report

3 children with recalcitrant atopic dermatitis found to have potential allergic contact dermatitis to bisabolol, a component of the Aquaphor Healing Ointment they were using to treat their atopic dermatitis.

Allergic contact dermatitis caused by lanolin (wool) alcohol contained in an emollient in three postsurgical patients.

Products

Aquaphor

Results / Report

3 patients (a 90-year-old woman, an 81-year-old woman and a 49-year-old woman) who underwent surgical procedures subsequently developed erythematous eruptions that were sharply demarcated to non-occlusive areas of their bandages. Patch testing showed positive reactions to Aquaphor, which were used in the dressings, and more specifically to lanolin.

Multiple modality treatment regimen in an aggressive resistant fungal hand infection: a case report.

Products

Aquaphor mixed with topical voriconazole

Vacuum Assisted Closure

Results / Report

A 3-year-old girl with lymphoblastic leukemia developed a Aspergillus flavus infection on her palm and 2 fingers. Serial debridement and topical Dakin's solution were unsuccessful in eliminating the infection. Topical voriconazole mixed with Aquaphor and followed by the use of VAC finally allowed progressive healing and eventual closure with a split-thickness skin graft.