Topical Oils for Wrinkles

Overseen By Nasima Afzal

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Integrative Skin Science and Research

Must not be taking: Retinoids, Antioxidants, Pigment reducers

Disqualifiers: Pregnancy, Nut allergy, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different topical oils can improve the appearance of facial wrinkles and fine lines. Researchers are testing three treatments: almond oil, almond oil with added vitamin E, and a tretinoin oil (known for treating acne and wrinkles) mixed with castor oil. Participants will apply the assigned oil to their face nightly for 16 weeks. The study seeks post-menopausal women with fair skin types who want to reduce facial wrinkles.

As an unphased trial, this study offers participants the chance to explore innovative skincare solutions and contribute to valuable research.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain topical cosmetic products, especially those with ingredients like retinoids, vitamin C, vitamin E, and nut oils. There is a 2-week period without these products before starting the study.

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

Research shows that the topical tretinoin used in this trial is generally safe for adults and children over 12. It is commonly used to treat acne and reduce fine wrinkles. Some individuals might experience mild side effects like skin irritation or redness. A review found that tretinoin at a dose similar to the one in this trial was well-tolerated by patients.

For almond oil, studies suggest it is safe for skin use. It is often included in lotions and creams without causing irritation. One assessment found that products with almond oil do not usually cause allergic reactions.

Almond oil with added vitamin E is also considered safe. Vitamin E is known for its skin benefits and typically does not cause irritation in small amounts. Overall, these ingredients are widely used in skincare and are well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for wrinkles because they leverage natural oils, which are generally well-tolerated by the skin. Unlike traditional wrinkle treatments like retinoid creams, chemical peels, or laser therapies, which can sometimes cause irritation or require recovery time, these topical oils are gentle and can be easily applied at home. The use of 0.025% Tretinoin oil augmented with castor oil combines a proven anti-aging ingredient with the soothing properties of castor oil, potentially reducing irritation. Meanwhile, almond oil, both on its own and when combined with 0.5% Vitamin E, offers antioxidant benefits that can help protect skin from damage while promoting moisture retention. This blend of effectiveness and gentleness makes these treatments particularly appealing for those looking to reduce wrinkles without harsh side effects.

What evidence suggests that this trial's treatments could be effective for wrinkles?

Research shows that tretinoin, provided in this trial as 0.025% Tretinoin oil with castor oil, can reduce fine wrinkles, uneven skin color, and roughness from sun exposure. Improvements, such as better skin elasticity and moisture, often appear in just 4-6 weeks. Another treatment option in this trial is Almond Oil, which strengthens the skin's outer layer and may lessen wrinkle severity. Additionally, Almond Oil with 0.5% Vitamin E is under study, as studies suggest that adding Vitamin E to almond oil could further enhance skin repair and flexibility. These treatments target visible signs of aging, offering promising options for improving the appearance of wrinkles. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with facial wrinkles, pigmentation issues, or dry skin. It's also relevant for those with Ehlers-Danlos Syndrome and collagen degeneration. Participants should be interested in testing topical treatments to improve skin appearance.

Inclusion Criteria

I have fine lines and wrinkles on my face.

I am a post-menopausal woman with fair to olive skin.

Exclusion Criteria

Individuals who are pregnant or breastfeeding

Prisoners

Those with a nut allergy or tocopherol allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply 1-2 drops of randomized topical product (Almond Oil, Almond Oil with Vitamin E, or Tretinoin oil with castor oil) on entire face nightly

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 0.025% Tretinoin oil augmented with castor oil
• Almond Oil augmented with 0.5% Vitamin E
• Topical Almond Oil

Trial Overview

The study tests the effects of three topical products: almond oil alone, almond oil with added Vitamin E, and tretinoin oil mixed with castor oil on facial wrinkles and other skin conditions like pigmentation and dryness.

How Is the Trial Designed?

Group I: Almond oil augmented with 0.5% Vitamin E Experimental Treatment 1 Intervention

Almond oil augmented with 0.5% Vitamin E. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks

Group II: Almond Oil Experimental Treatment 1 Intervention

Almond Oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks

Group III: 0.025% Tretinoin oil augmented with castor oil Experimental Treatment 1 Intervention

0.025% Tretinoin oil augmented with castor oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks

0.025% Tretinoin oil augmented with castor oil is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Tretinoin for:

• Acne vulgaris
• Fine facial wrinkles
• Mottled facial discoloration (pigmentation)
• Tactile facial roughness

Approved in European Union as Tretinoin for:

• Acne vulgaris
• Fine facial wrinkles
• Mottled facial discoloration (pigmentation)
• Tactile facial roughness

Approved in Canada as Tretinoin for:

• Acne vulgaris
• Fine facial wrinkles
• Mottled facial discoloration (pigmentation)
• Tactile facial roughness

Who Is Running the Clinical Trial?

Integrative Skin Science and Research

Lead Sponsor

Trials

33

Recruited

2,000+

Published Research Related to This Trial

The developed solid lipid nanoparticle gel containing Isotretinoin and α-tocopherol acetate demonstrated a sustained drug release over 24 hours, indicating effective delivery of the active ingredients for acne treatment.

The gel showed no skin irritation in tests on rabbits and exhibited strong anti-acne activity in a rat model, suggesting it is a safe and effective topical formulation for treating acne.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isotretinoin and α-tocopherol acetate-loaded solid lipid nanoparticle topical gel for the treatment of acne. Gupta, S., Wairkar, S., Bhatt, LK.[2021]

The study found that the delivery system and concentration of alpha-tocopherol (alpha-T) significantly affect its absorption through the skin, with a microemulsion containing isopropyl myristate being the most effective delivery method.

Using a hydroalcoholic gel resulted in higher alpha-T permeation compared to other gel formulations, indicating that the choice of delivery system is crucial for enhancing skin absorption of antioxidants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of formulation on the topical delivery of alpha-tocopherol. Rangarajan, M., Zatz, JL.[2014]

Argan oil has been traditionally recognized for its cardioprotective properties and potential benefits in treating skin infections, primarily due to its high content of mono-unsaturated fatty acids and various minor bioactive compounds.

Recent evaluations have highlighted argan oil's antiproliferative, antidiabetic, and cardiovascular-protective effects, but the lack of clinical data limits our understanding of its actual therapeutic relevance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic potential of argan oil: a review. Monfalouti, HE., Guillaume, D., Denhez, C., et al.[2011]

The study found that the formulation of alpha-tocopheryl acetate (alpha-TAc) significantly affects its permeation and metabolism in pig skin, which is similar to human skin, with the isopropyl myristate solution and certain gels showing higher metabolism rates.

About 15-20% of alpha-TAc was metabolized to its active form, alpha-tocopherol, in the viable skin, indicating that the choice of delivery system is crucial for maximizing the effectiveness of topical vitamin E formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of formulation on the delivery and metabolism of alpha-tocopheryl acetate. Rangarajan, M., Zatz, JL.[2017]

The study developed eco-friendly oil-in-water nanoemulsions to enhance the delivery of bakuchiol, a natural alternative to retinol, using sustainable methods like supercritical CO2 extraction.

In vitro and ex vivo tests showed that these nanoemulsions are biocompatible and improve skin permeability, demonstrating potential anti-aging effects comparable to commercial retinol products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Engineering of "Green" Nanoemulsions for Enhanced Topical Delivery of Bakuchiol Achieved in a Sustainable Manner: A Novel Eco-Friendly Approach to Bioretinol. Lewińska, A., Domżał-Kędzia, M., Maciejczyk, E., et al.[2021]

Alpha-tocopherol acetate (ATA), a prodrug of vitamin E, shows varying permeation properties through human cadaver skin depending on the formulation, with isopropyl myristate significantly enhancing its permeability compared to other vehicles.

The study utilized modified Franz diffusion cells to analyze the permeation of ATA from different solutions and gels, indicating that formulation choice can impact the delivery of this antioxidant to the skin, which is important for its protective effects against skin damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Permeation study of five formulations of alpha-tocopherol acetate through human cadaver skin. Mahamongkol, H., Bellantone, RA., Stagni, G., et al.[2017]

In a study involving 22 dry eye patients, an oil-in-water emulsion of 0.01% all-trans-retinoic acid (tretinoin) showed significant improvements in tear production and tear film stability, as measured by the Schirmer I test and tear film break-up time (BUT).

Although retinoic acid did not alleviate symptoms like dryness and photophobia more than a placebo, it maintained corneal and conjunctival health, suggesting it could be a promising treatment option for dry eye patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of retinoic acid ophthalmic emulsion in dry eye. Selek, H., Unlü, N., Orhan, M., et al.[2019]

Melaleuca alternifolia essential oil, especially in a nanoemulsion form, can penetrate deeper into the skin layers, reaching the viable epidermis and improving skin morphology, which is beneficial for preventing photoaging.

In a clinical study with 40 male participants over 90 days, both the pure essential oil and the nanoemulsion showed improvements in skin characteristics, including increased papillary depth and enhanced collagen fibers, indicating their efficacy in skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cosmetic Formulations with Melaleuca alternifolia Essential Oil for the Improvement of Photoaged Skin: A Double-Blind, Randomized, Placebo-Controlled Clinical Study. Hugo Infante, V., Maria Maia Campos, P., Darvin, M., et al.[2023]

Tretinoin tocoferil, a safer alternative to all-trans retinoic acid (ATRA), effectively promotes healing in skin ulcers by stimulating granulation tissue formation and enhancing macrophage migration, with significantly lower toxicity (150 times less than ATRA).

In leukemia treatment, tretinoin tocoferil not only induces differentiation in HL-60 cells but also works synergistically with ATRA and vitamin D3 to inhibit cell proliferation, suggesting its potential as a therapeutic option for myelomonocytic leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tretinoin tocoferil as a possible differentiation-inducing agent against myelomonocytic leukemia. Makishima, M., Honma, Y.[2019]

In a study with male Fischer 344 rats, soy protein isolate (SPI) was found to be as effective as fish oil in reducing retinoid-induced hypertriglyceridemia, with serum triglyceride levels significantly lower in the SPI and fish oil groups compared to the control group.

Both SPI and fish oil diets resulted in similar serum triglyceride concentrations, suggesting that SPI could potentially be a viable alternative to fish oil for managing triglyceride levels in humans undergoing retinoid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effectiveness of soy protein isolate and fish oil for reducing the severity of retinoid-induced hypertriglyceridemia. Radcliffe, JD., Czajka-Narins, DM.[2006]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9112391/

Topical tretinoin for treating photoaging: A systematic review ...

After only 4–6 weeks of therapy, there were improvements in mottled hyperpigmentation, fine wrinkles, elasticity, hydration, and collagen deposition. These ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9618501/

Use of Retinoids in Topical Antiaging Treatments

For example, retinol at a concentration of 0.25% is considered to be as effective as 0.025% tretinoin, without significant side effects and irritation [79].

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/jocd.12381

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Treatment with a double-conjugate retinoid cream achieved early, progressive improvements in the appearance of Fine Lines/Wrinkles, Dyschromia, ...

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Adapalene (Differin) versus Tretinoin (Retin-A) for Wrinkles

The analysis found that tretinoin is effective at treating wrinkles and other signs of photoaging. This was true in both short-term studies (less than 6 months) ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0190962297700586

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CONCLUSION. Topical tretinoin is effective in reducing fine wrinkling, mottled hyperpigmentation, and skin roughness in patients with photodamaged skin.

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mayoclinic.org

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Tretinoin (topical route) - Side effects & dosage

One of the tretinoin creams is used to treat fine wrinkles, dark spots, or ... Safety and efficacy have not been established. Appropriate studies have ...

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Tretinoin topical (Retin-A, Renova, and others) - Uses, Side ...

Topical tretinoin is commonly used for acne. Some topical tretinoin products are used to help improve how fine wrinkles on the face look.

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Tretinoin: Uses, Dosage, Side Effects, Warnings

Improvement in fine wrinkling may not be observed for up to 6 months. Use: Adjunctive agent for the mitigation of fine facial wrinkles in ...

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Tretinoin (Retin-A): Uses, Side Effects, Tips & More

Retin-A (tretinoin) is generally safe for adults and children 12 years and older to use to treat acne, but it does have some side effects. It's normal to feel a ...