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

Trial Summary

What is the purpose of this trial?

Investigate the topical use of almond oil, almond oil augmented with 0.5% vitamin E, 0.025% tretinoin oil augmented with castor oil on the appearance of facial fine lines and wrinkles, pigmentation, hydration, trans-epidermal water loss, and sebum excretion rate.

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.

What data supports the effectiveness of the treatment for wrinkles?

The research on alpha-tocopherol acetate (a form of Vitamin E) shows it can penetrate the skin and convert to an active form, which may help protect against skin damage. Additionally, tretinoin, a form of Vitamin A, is known for its anti-aging effects, suggesting that the combination of these ingredients could be beneficial for reducing wrinkles. ^{1 2 3 4 5}

Is the topical use of tretinoin and almond oil safe for humans?

Tretinoin tocoferil, a form of tretinoin, is safely used to treat skin ulcers and has been shown to be much less toxic than other forms of tretinoin in animal studies. Additionally, formulations containing bakuchiol, a natural alternative to retinol, have shown high cell viability and excellent biocompatibility in human skin tests, suggesting that similar topical treatments are generally safe. ^{2 5 6 7 8}

How does the topical oil treatment for wrinkles differ from other treatments?

This treatment is unique because it combines 0.025% Tretinoin oil with castor oil and Almond Oil with 0.5% Vitamin E, offering a novel blend of ingredients that may enhance skin penetration and provide antioxidant benefits. Unlike other treatments, this combination leverages the known anti-aging effects of Tretinoin and the moisturizing and protective properties of almond oil and vitamin E. ^{2 3 4 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

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

Evaluation of retinoic acid ophthalmic emulsion in dry eye. [2019]

2. Switzerland 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. [2021]

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

Permeation study of five formulations of alpha-tocopherol acetate through human cadaver skin. [2017]

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

Effect of formulation on the delivery and metabolism of alpha-tocopheryl acetate. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Therapeutic potential of argan oil: a review. [2011]

6. England pubmed.ncbi.nlm.nih.gov

Isotretinoin and α-tocopherol acetate-loaded solid lipid nanoparticle topical gel for the treatment of acne. [2021]

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

Tretinoin tocoferil as a possible differentiation-inducing agent against myelomonocytic leukemia. [2019]

8. United States 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. [2006]

9. United States 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. [2023]

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

Effect of formulation on the topical delivery of alpha-tocopherol. [2014]