Retinol for Skin Aging
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is being conducted to confirm whether skin tape stripping methodology can identify changes in gene expression (i.e. whether different genes are turned on to make proteins) in aged skin after use of a retinoid.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications, but if you're on a medication that could mask a negative reaction or influence study results, you may need to stop, as determined by the principal investigator.
What data supports the idea that Retinol for Skin Aging is an effective treatment?
The available research shows that Retinol, specifically in the form of tretinoin, is effective in treating skin aging. Studies have demonstrated that tretinoin can improve the appearance of aged skin, with significant improvements in fine and coarse wrinkles, skin texture, and a reduction in age spots after 8 to 12 months of use. One study found a 71% decrease in age spots. Another study compared prescription tretinoin with a non-prescription retinol product and found both significantly improved signs of skin aging, with no major differences in effectiveness. Overall, tretinoin is the only treatment with proven benefits for reversing signs of photoaging, according to the research.
12345What safety data exists for retinol treatments for skin aging?
Topical retinoids like tretinoin have favorable safety profiles and are effective for various skin disorders, including aging. Common local side effects include peeling, erythema, dryness, burning, and itching, which can be minimized with precautions like using moisturizers and avoiding sunlight. Tretinoin has been shown to improve aged skin with mild, transient side effects. Alitretinoin gel was well tolerated in a small study, showing potential for treating photoaging. Overall, topical retinoids are considered safer than systemic retinoids.
16789Is retinol a promising treatment for skin aging?
Yes, retinol is a promising treatment for skin aging. It is effective in improving the appearance of aged skin and is widely used in skincare products. Retinol is a form of vitamin A and works by promoting skin renewal, which can help reduce signs of aging.
110111213Eligibility Criteria
This trial is for individuals with signs of skin aging or acne who are interested in testing a topical retinol product. Participants should not be currently using any night cream.Inclusion Criteria
Is able to read, write, speak, and understand English
Has clinically determined moderate photodamage (defined as a score of 4 - 6 on a 0- 9-point scale) on the face at Visit 1
I am generally healthy.
+1 more
Exclusion Criteria
Is currently participating in any other clinical study or has participated in any product-use study within 30 days prior to the study visit
I do not have skin conditions that could affect the study.
I am not on medication that could affect the study results.
+10 more
Participant Groups
The study aims to see if a non-invasive method called skin tape stripping can detect gene expression changes in aged or acne-affected skin after applying a retinol-based night cream.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention CellExperimental Treatment1 Intervention
Investigational Night Cream plus auxiliary cleanser and sunscreen
Group II: No InterventionActive Control1 Intervention
Auxiliary cleanser and sunscreen only
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dermatology Consulting Services, PLLCHigh Point, NC
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Who Is Running the Clinical Trial?
Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
References
Topical tretinoin in the treatment of aging skin. [2019]We review the use of topical tretinoin (all-trans-retinoic acid) in the treatment of aging skin. We have found topical tretinoin capable of improving aged-appearing skin in both a double-blind, vehicle-controlled trial and our clinic patients. The most impressive improvement occurs after application of tretinoin 0.1% cream for 8 to 12 months. Side effects have been limited to a mild, transient, and clinically insignificant burning sensation in the eyes and mild irritation of tretinoin-exposed skin.
Sustained improvement with prolonged topical tretinoin (retinoic acid) for photoaged skin. [2019]We performed a 22-month trial of topical tretinoin (retinoic acid) in the treatment of photoaging. Thirty patients participated in a 4-month, randomized, blinded, vehicle-controlled study that has been reported previously; 21 patients continued tretinoin therapy on an open-label basis, participating in the study for a total of 10 months, and 16 patients continued for 22 months. During the open-label study, the statistically significant improvement that had occurred in fine and coarse wrinkling and skin texture during our original study was sustained, despite reductions in dose or frequency of application of tretinoin. The number of discrete lentigines decreased by 71% compared with the number before therapy. Histologic findings included a statistically significant thickening of the epidermis. Side effects were limited to a cutaneous retinoid reaction that diminished as therapy proceeded.
Photoaging and the skin. The effects of tretinoin. [2013]The appearance of photoaged skin is cosmetically unacceptable to many in our society. Ostensibly, avoidance of ultraviolet light and sunlight from early childhood is most desirable but not likely to happen in our culture. Tretinoin is the only pharmacologic compound shown to partially reverse some signs of photoaging. Improvement with tretinoin therapy has been quantified clinically and histologically. A major degree of improvement occurs in 6 to 12 months, and maintenance treatment one to three times per week may continue this response. Tretinoin therapy should optimally be used with daily moisturizer and sunscreen applications. Psychosocial benefits of tretinoin therapy, use of tretinoin for intrinsically aged or non-Caucasian skin, and higher-strength tretinoin therapy for severely photoaged skin need to be further explored. It is possible that some subsets of patients with photoaged skin may respond better than others.
A randomized, double-blind, controlled comparative trial of the anti-aging properties of non-prescription tri-retinol 1.1% vs. prescription tretinoin 0.025%. [2013]Vitamin A and its derivatives (commonly termed retinoids) are widely used in topical anti-aging products. Certain retinoids such as retinol and its esters are available without a prescription, while others such as tretinoin are available only via prescription. A randomized, double-blind, controlled clinical study was conducted to compare the efficacy and tolerability of a tri-retinol 1.1% gradual release cream vs. tretinoin 0.025% cream in females with mild-to-moderate facial photodamage. Subjects applied the test product to the entire face in the evening after cleansing in a progressively increasing frequency starting twice weekly for the first week, followed by three times weekly during the second week and then daily as tolerated for the third week and beyond. Treatment was continued for a total of three months. Clinical evaluations and standardized digital photographs were performed at baseline and after four, eight, and 12 weeks of treatment. Self-assessment questionnaires were completed by the subjects at four, eight, and 12 weeks to assess perceived efficacy of the test products. Thirty-four subjects (16: tri-retinol and 18: tretinoin) completed the study. Both test products significantly improved signs of photodamage, including fine and coarse periocular wrinkles, skin firmness, skin tone, mottled pigmentation, tactile roughness, overall photodamage and global photodamage improvement. There were no significant differences in efficacy between the two products for these assessments. The adverse effects (which were graded as mild or less) were those typically seen with topical retinoids. Subjects reported >93 percent overall satisfaction with both products at weeks 8 and 12.
Cosmeceuticals: focus on topical retinoids in photoaging. [2008]Evidence from a randomized clinical trial showed that, in spite of the many surgical procedures effective in ameliorating the clinical appearance of photoaged skin, the only medical therapy with proven benefits in photoaged skin are topical retinoids, in particular tretinoin, isotretinoin, and tazarotene. The application of retinoids might not only clinically and biochemically repair photoaged skin, but their use might also prevent photoaging. Furthermore, new evidence suggests a beneficial role of topical retinoids in the treatment of intrinsically aged skin.
An update on the safety and efficacy of topical retinoids. [2013]Adapalene, tazarotene, and tretinoin are topical retinoids that are approved by the US Food and Drug Administration (FDA) and have overall favorable safety profiles. These agents are effective in a variety of skin disorders. Local adverse events, seen especially during the early course of treatment, include peeling, erythema, dryness, burning, and itching. The degree of local skin intolerance varies among patients and may relate to the vehicle formulation used. These local effects can be minimized by decreasing exposure to sunlight, avoiding extreme temperatures, and using moisturizers. Use of these agents has been found to be advantageous over current systemic retinoids from a toxicologic perspective. This article reviews the safety, efficacy, and photostability of the available topical retinoids.
A non-retinol retinoic acid receptor-γ (RAR-γ/NR1B3) selective agonist, tectorigenin, can effectively inhibit the ultraviolet A-induced skin damage. [2022]Long-term ultraviolet (UV) exposure can cause inflammation, pigmentation and photoaging. All-trans retinoic acid (ATRA/tretinoin) is a commonly used retinoic acid receptor (RAR) agonist in the clinical treatment of UV-induced skin problems. However, the use of such drugs is often accompanied by systemic adverse reactions caused by nonspecific activation of RARs. Therefore, this study was designed to screen for a novel RAR-γ-selective agonist with high safety.
Historical perspectives of tretinoin. [2019]The vitamin A acid story began when topical application of vitamin A (retinol) produced no therapeutic results in dyskeratotic conditions. It was logical to try metabolites of retinol topically. I published results of studies in 1962 that showed that topical tretinoin was beneficial in ichthyosis, actinic keratoses, and other hyperkeratotic conditions. It was reported in 1969 that topical tretinoin was effective in acne vulgaris, principally by preventing and dislodging comedones. It was subsequently demonstrated that tretinoin produced a distinctive kind of hyperplasia of human epidermis that was associated with early shedding of horny cells. Knowledge that the keratinization process was being profoundly altered stimulated interest in synthesizing retinol derivatives (retinoids) that could be administered orally. The development of 13-cis-retinoic acid was an outcome of this interest, a compound that astonished dermatologists by often producing permanent clearing of acne conglobata. The antitumor effects of tretinoin were already demonstrated by 1974, when it was shown to cause regression in many basal cell cancers. Today the cancer chemopreventive capability of retinoids is being intensively investigated in various organs. An international symposium held in Flims, Switzerland in 1975 demonstrated keen awareness of the therapeutic potential of tretinoin and the rapid growth of basic knowledge of the pharmacology of retinoids. From extensive clinical experience new applications for topical tretinoin came to light, ranging from the treatment of flat warts, lichen planus, and Darier's disease, and most recently in retarding photoaging. Perhaps for the first time in history, dermatologists can take credit for pioneering a drug development program that has had a profound influence on medical practice.
Open-label pilot study of alitretinoin gel 0.1% in the treatment of photoaging. [2018]Alitretinoin (9-cis-retinoic acid) is an FDA-approved topical therapy for the treatment of Kaposi sarcoma. Alitretinoin is a naturally occurring endogenous retinoid that binds to and activates all known intracellular retinoic acid receptor (RAR) subtypes alpha, beta, and gamma and retinoic X receptor (RXR) subtypes alpha, beta, and gamma. Photoaging of the skin is the result of accumulated exposure to solar UV radiation. Several topically applied retinoids have been proven clinically effective for treating the appearance of photoaging. Tretinoin and tazarotene, which have been shown to improve photodamaged skin, bind RAR subtypes only. The theoretic benefit of alitretinoin gel 0.1% (Panretin) in the treatment of photoaged skin stems from the binding and activation of both RARs and RXRs, which promote the repair mechanisms in damaged skin. The objective of this study was to evaluate the safety and efficacy of topical alitretinoin gel 0.1% in the treatment of photodamaged skin. The treatment was well tolerated by participants (N=20) and subjectively showed improvement of benign skin lesions (eg, seborrheic keratoses) and precancerous lesions (eg, actinic keratoses). Larger, blinded, controlled trials are needed to investigate the role of this novel retinoid in the treatment of photoaging.
Efficacy and safety of retinaldehyde 0.1% and 0.05% creams used to treat photoaged skin: A randomized double-blind controlled trial. [2018]Although topical retinoic acid effectively restores photoaged skin, the associated irritation limits the utility of the material. Retinaldehyde (RAL) is the natural precursor of retinoic acid and can also be used to treat photoaged skin; the safety profile is good.
Improvement of naturally aged skin with vitamin A (retinol). [2008]To evaluate the effectiveness of topical retinol (vitamin A) in improving the clinical signs of naturally aged skin.
Clinical efficacy and reflectance confocal microscopy monitoring in moderate-severe skin aging treated with a polyvinyl gel containing retinoic and glycolic acid: An assessor-blinded 1-month study proof-of-concept trial. [2021]Retinoids and alpha-hydroxy acids are commonly used topically as anti-aging substances. Current medical devices contain retinoic acid (0.02%) and glycolic acid (4%) in a polyvinyl gel vehicle (R-G gel). There are still no clinical data nor objective evaluation of the anti-aging effect this product has in the short term.
A comparative study of the effects of retinol and retinoic acid on histological, molecular, and clinical properties of human skin. [2022]All-trans retinol, a precursor of retinoic acid, is an effective anti-aging treatment widely used in skin care products. In comparison, topical retinoic acid is believed to provide even greater anti-aging effects; however, there is limited research directly comparing the effects of retinol and retinoic acid on skin.