Reply to: "Is oral collagen the elixir of youth?"

Following letter provides answers and explanations for the correspoundance titled "Is oral collagen the elixir of youth." They have admitted the strengths of our study and also have raised some questions about it, which we aim to provide answers and explanations.

Tolerability and efficacy assessment of an oral collagen supplement for the improvement of biophysical and ultrasonographic parameters of skin in middle eastern consumers.

BACKGROUND: Topical skin care products often do not reach the deeper layers of the skin, and oral hydrolyzed collagen is one of the newest and most popular systemic supplementations for skin rejuvenation. However, there are limited information in case of Middle Eastern consumers OBJECTIVE: The purpose of this study was to evaluate the tolerability and efficacy of an oral collagen supplement for improvement of skin elasticity, hydration, and roughness in Middle Eastern consumers. METHODS AND MATERIALS: It was a 12-week, before-after clinical study, conducted on 20 participants (18 women and 2 men) aged 44.15 ± 5.36 years with skin type III-IV. Skin elasticity parameters (R0, R2, R5, and R7), skin hydration and friction, as well as the thickness and echo density of the dermis, were measured after six and 12 weeks daily intake of the study product, as well as 4 weeks after stopping its use (week 16). Participants' satisfaction was assessed on the basis of their answers to the standard questionnaire, and tolerability of the product was assessed by monitoring the adverse effects. RESULTS: A significant improvement was detected in R2, R5, and skin friction at week 12 (p-values 0.041, 0.012 and <0.01, respectively). At week 16, the values remained at an increased level, which indicates the persistence of the results. The increase of dermis density in week 16 was also significant (p-value = 0.03). Moderate overall satisfaction was reported with the treatment, and a few gastrointestinal complications were reported. CONCLUSION: The study demonstrated that oral collagen peptides could significantly improve the skin elasticity, roughness, and dermis echo density, and they also proved to be safe and well-tolerated.

Evaluation of tolerability and efficacy of a topical emulgel containing nanoliposomal ruxolitinib phosphate in the treatment of mild atopic dermatitis: a before-after single group pilot study.

BACKGROUND: Ruxolitinib is a JAK1/2 inhibitor, which inhibits the signal transduction of interferon-gamma, a cytokine implicated in the pathogenesis of atopic dermatitis (AD). In this before-after single group phase IIA pilot study, we investigated the efficacy of topical nanoliposomal ruxolitinib phosphate (RuxoLip) emulgel in mild AD. METHODS: Clinical evaluation was conducted on 10 patients with mild AD. The efficacy of the product as well as patient satisfaction was evaluated by local scoring atopic dermatitis (SCORAD) of AD. In addition, trans-epidermal water loss (TEWL), stratum corneum (SC) hydration, sebum, erythema, melanin content, and ultrasonographic parameters were measured before, and two and four weeks after treatment. RESULTS: Four weeks of treatment reduced SCORAD, itching, and burning (p = .001, .001, and .001, respectively) and increased hydration, sebum, and epidermal density (p = .001, .018, and .037, respectively). SCORAD and other skin biophysical parameters improved within two weeks of treatment and then were in plateau for up to four weeks. CONCLUSIONS: The topical ruxolitinib emulgel has good short-term efficacy and tolerability.

Biophysical and ultrasonographic changes of acute Old World cutaneous leishmaniasis skin lesions in comparison with uninvolved skin: A possible tool for non-invasive early detection and treatment outcome assessment.

Cutaneous leishmaniasis (CL) is a skin disease caused by intracellular protozoa, which is endemic in Iran. The goal of this study was to compare biophysical characteristics in CL lesions with uninvolved skin. Stratum corneum hydration, transepidermal water loss, surface friction, pH, sebum, melanin, erythema, temperature, elasticity parameters (R0, R2, and R5), thickness and echo-density of epidermis and dermis were measured on the active erythematous indurated part of a typical CL lesion in 20 patients, and compared with the same location on the other side of the body as control. Paired t-test was used for statistical analyses and a p < 0.05 was considered significant. Melanin content, R2 and echo-density of dermis were significantly lower, whereas transepidermal water loss, friction index, pH, erythema index, temperature, and the thickness of dermis were significantly higher in CL lesions. There was no significant difference in stratum corneum hydration, sebum, R0, R5, thickness of epidermis, and density of epidermis between CL and normal skin. CL lesions are characterized by certain changes in biophysical and ultrasonographic properties, which are mostly correlated with histological features. These changes are likely to be useful in the non-invasive early detection of CL and also as treatment outcome measures for clinical trials of new treatment modalities for CL in the future.

Brightening effect of Ziziphus jujuba (jujube) fruit extract on facial skin: A randomized, double-blind, clinical study.

Ziziphus jujuba Mill. (jujube) is an invaluable medicinal plant in traditional and modern medicine. Jujube syrup is a complex of herbal extracts including Z. jujuba, Berberis vulgaris, Rhus coriaria, Prunus domestica, and Rosa damascene. The purpose of the present study was to formulate and investigate the efficacy and safety of jujube syrup on brightening of facial skin. In this randomized, double-blind, controlled clinical study, 46 participants consumed jujube syrup or placebo (23 in each group) twice a day for 8 weeks. The number of pigments, area of pigmentation, and physician's global assessment score (PGAS) were evaluated at baseline and after 8 weeks. The results showed the amounts of total phenolics and flavonoids were 81.97 ± 0.25 and 4.98 ± 1.04 mg/ml, respectively. The amounts of organic acids (gallic acid and chlorogenic acid) were quantified at 1140 ± 17.65 and 1520 ± 25.77 µg/ml, respectively. The amounts of total phenolic and flavonoids were stable under accelerated conditions. Eight weeks after treatment, the number of pigment counts reduced to 0.545 ± 0.307 compared to the placebo group. Moreover, the pigmented area and its percentages were significantly reduced to 0.556 ± 0.285 and 0.561 ± 0.288 in jujube syrup compared with placebo, respectively. Jujube syrup is efficient and safe for treating hyperpigmentation of the face.

Skin biophysical assessments of four types of soaps by forearm in-use test.

BACKGROUND: While soaps are the most commonly used cleansing agents for human skin, they also damage the epidermal barrier and potentially increase the risk of disorders such as contact dermatitis. AIMS: This study set out to compare the potential skin irritancy of four types of soaps and their effects on the skin barrier function and biophysical parameters. METHODS: In a nonblinded comparative study, three types of soaps (alkaline, creamy, and glycerin soaps), and a syndet were applied to four different groups of 15 healthy subjects. Subjects washed their left forearm with the respective soap at home at least four times a day for seven days. Biophysical skin parameters, including transepidermal water loss (TEWL), erythema, friction, and pH, were measured at various time points using the Cutometer® MPA 580. RESULTS: After the first wash, a significant increase in TEWL was observed for all groups compared to the pre-intervention period. For the alkaline soap, a substantial increase in pH was observed at all time points compared to the baseline. Syndet, the only acidic soap in this study, showed a significant decrease in pH at the last time compared to all time points. The mean value of erythema was significantly higher in alkaline soap users than glycerin and creamy soap users. CONCLUSION: Our study showed that alkaline-based soaps could cause erythema and increase TEWL and skin pH due to their strong cleansing action, and the addition of compounds such as glycerin can modify these effects. A newer generation of soap containing a mild surfactant such as syndets causes less skin damage.

Efficacy assessments of tretinoin-loaded nano lipid carriers in acne vulgaris: a double blind, split-face randomized clinical study.

Here, we assessed the efficacy and safety of Nano lipid carrier (NLC) drug delivery system containing tretinoin (NLC-TRE) in comparison with the conventional 0.05% tretinoin cream (TRE cream) in mild to moderate acne vulgaris. A stable and appropriate NLC-TRE formulation was prepared using a high-pressure homogenizer and particle characterization and physicochemical properties were evaluated under accelerated conditions. Efficacy assessment was performed via a split-face clinical study, by comparing the number of acne lesions, porphyrin production and skin biophysical parameters in both sides of the face randomly treated with NLC-TRE and TRE cream. Plasma concentration of tretinoin after topical application of NLC-TRE was measured for primary safety evaluation. We acquired a stable, spherical nanoparticles with particle size of 118.5 nm, PI equal to 0.485 and ZP of - 44.7 mV. The rate of decrease of acne lesions was significantly higher in NLC- TRE side (p value < 0.001). The size and intensity of porphyrin production in pilosebaceous follicles were significantly reduced only on NLC-TRE side (p value < 0.01). The plasma concentration of the tretinoin, after 8 weeks' application remained lower than the toxic levels. The NLC-TRE formula provides better efficiency and good loading capacity of TRE in the drug delivery system.

The in vitro effect of nanoliposomal amphotericin B against two clinically important dermatophytes.

AIMS: The present study aimed to investigate the antifungal activity of amphotericin B-loaded nanoliposomes against Trichophyton interdigitale and Trichophyton rubrum. Moreover, it was attempted to assess the obtained resistance in vitro. METHODS: In total, 29 archived clinical strains, namely, T. interdigitale (n = 16) and T. rubrum (n = 13), were included in this study. These strains were determined using a previous ITS1-ITS2 region sequence. Moreover, a liposomal formulation of amphotericin B was formulated by a thin-film hydration method. Particle size, polydispersity index (PdI), and zeta potential (ZP) were measured by a Zetasizer. Furthermore, physicochemical properties, such as appearance, aggregation of particles, particle size, PdI, and ZP, were determined at 0-, 1-, and 3-month intervals. A scanning electron microscope (SEM) was also used to examine nanoparticles structure. The minimum inhibitory concentration (MIC) of amphotericin B-loaded nanoliposomes, itraconazole, efinaconazole, terbinafine, and ciclopirox was determined according to the protocol of the broth microdilution method of CLSI M38-A2. The morphological changes of T. interdigitale and T. rubrum strains exposed to the amphotericin B-loaded nanoliposomes were observed using SEM. RESULTS: The amphotericin B-loaded nanoliposomes displayed a lower MIC compared to those of the amphotericin B and liposomes when used separately. Based on the results, amphotericin B-loaded nanoliposomes induced no drug resistance in any of the tested strains. CONCLUSION: Accordingly, amphotericin B-loaded nanoliposomes can be a potent antifungal for the topical treatment of onychomycosis. There was no in vitro evidence regarding the resistance of the tested strains to amphotericin B-loaded nanoliposomes. This reflects that amphotericin B-loaded nanoliposomes have a low probability to induce drug resistance in dermatophyte species.

Susceptibility Pattern of Caspofungin-Coated Gold Nanoparticles Against Clinically Important Candida Species.

Purpose: The present study was performed to examine whether caspofungin-coated gold nanoparticles (CAS-AuNPs) may offer the right platform for sensitivity induction in resistant isolates. Methods: A total of 58 archived Candida species were enrolled in the research. The identification of Candida spp. was performed using polymerase chain reaction-restriction fragment length polymorphism and HWP1 gene amplification approaches. The conjugated CAS-AuNPs were synthesized and then characterized using transmission electron microscopy (TEM) and Zetasizer system to determine their morphology, size, and charge. Furthermore, the efficacy was assessed based on the Clinical and Laboratory Standards Institute M60. Finally, the interaction of CAS-AuNPs with Candida element was evaluated via scanning electron microscopy (SEM). Results: According to the TEM results, the synthesized CAS-AuNPs had a spherical shape with an average size of 20 nm. The Zeta potential of CAS-AuNPs was -38.2 mV. Statistical analyses showed that CAS-AuNPs could significantly reduce the minimum inhibitory concentration against C. albicans (P =0.0005) and non-albicans Candida (NAC) species (P < 0.0001). All isolates had a MIC value of ≥ 4 µg/ml for CAS, except for C. glabrata. The results of SEM analysis confirmed the effects of AuNPs on the cell wall structure of C. globrata with the formation of pores. Conclusion: According to findings, CAS-AuNPs conjugates had significant antifungal effects against Candida spp. Therefore, it can be concluded that the encapsulation of antifungal drugs in combination with NPs not only diminishes side effects but also enhances the effectiveness of the medications.

Biophysical and ultrasonographic changes in pityriasis rosea compared with uninvolved skin.

BACKGROUND: Pityriasis rosea (PR) is a common, self-limited, inflammatory papulosquamous skin disease with a possible viral etiology. OBJECTIVE: The goal of this study was to evaluate skin biophysical properties in patients with PR compared with uninvolved skin to better understand the pathogenesis of PR. METHODS: Stratum corneum hydration, transepidermal water loss, surface friction, pH, sebum, melanin, erythema, temperature, elasticity parameters (R0, R2, R5), thickness, and echodensity of the epidermis and dermis were measured on lesions of classic PR in 21 patients and compared with control sites (average of uninvolved perilesional and symmetrical skin) with a paired t test. RESULTS: Stratum corneum hydration (p < .001), R0 (p = .003), R2 (p = .001), R5 (p = .003), and echodensity of the dermis (p = .006) were significantly lower, whereas transepidermal water loss (p = .001), pH (p < .001), and erythema (p < .001) were significantly higher in PR lesions. There was no significant difference in friction index, sebum, melanin content, temperature, thickness of the epidermis and dermis, and echodensity of the epidermis between PR and normal skin. CONCLUSION: PR skin is characterized by certain alterations in biophysical properties, which are mostly correlated with histologic changes. These changes may be helpful in early, noninvasive diagnosis of PR.

Drug Sensitivity Profile of Fungi Isolated from Onychomycosis Patients and Evaluation of Squalene Epoxidase Mutation in One Terbinafine-Resistant Trichophyton mentagrophytes Species.

Background: The resistance to treatment of onychomycosis is increasingly reported. The present study aimed to assess the antifungal activity of itraconazole, terbinafine, luliconazole, and efinaconazole against dermatophytes, molds, and also yeast isolated from patients with onychomycosis. Furthermore, the mechanism of resistance to terbinafine in resistant Trichophyton mentagrophytes species was evaluated using the squalene epoxidase (SQLE) gene sequence. Methods: A total of 71 fungal isolates were collected from 97 patients with suspected onychomycosis. The identification of fungal species was performed using conventional and molecular approaches. In vitro drug susceptibility for itraconazole, terbinafine, luliconazole, and efinaconazole was carried out using the broth microdilution method according to the CLSI-M60 and CLSI-M38 3rd ed., respectively. The SQLE gene of one terbinafine-resistant T. mentagrophytes was amplified using the specific primers. Results: Efinaconazole and luliconazole demonstrated higher effectiveness against all isolates in the study. One mismatch was detected at position 1177, which showed A → C change associated with Phe397Leu amino acid substitution of the SQLE protein in terbinafine-resistant T. mentagrophytes. Conclusion: The occurrence of resistant strains of organisms causing onychomycosis should be considered and evaluated. Furthermore, the identification of amino acid changes responsible for resistance to antifungals is a useful consideration in drug-target interaction.

Biophysical and ultrasonographic changes in early patch/plaque stage of mycosis fungoides, compared with uninvolved skin.

BACKGROUND: The goal of this study was evaluation of the skin biophysical properties in early patch/plaque stage of mycosis fungoides (MF) and its comparison with uninvolved skin in order to gain a better understanding of the pathogenesis of diseases. MATERIALS AND METHODS: The stratum corneum hydration, transepidermal water loss (TEWL), surface friction, pH, sebum, melanin, erythema, temperature, elasticity parameters (R0, R2, R5), thickness, and echo density of epidermis and dermis were measured on lesions of 21 patients and compared with controls (average measures of uninvolved perilesional and symmetrical skins) by paired sample t test. RESULTS: Stratum corneum hydration (P < 0.001) and echo density of dermis (P = 0.044) were significantly lower, whereas pH (P-value = 0.007), erythema (P < 0.001), and melanin content (P = 0.007) were significantly higher in lesions. There was not any significant difference in TEWL, friction index, sebum, temperature, R0, R2, R5, thickness of epidermis and dermis, and echo density of epidermis between lesions and normal skin. CONCLUSION: Parapsoriasis/MF lesions are specified by a set of certain changes in biophysical properties which are mainly correlated with histological changes. These sets of alterations may help in noninvasive, early diagnosis of parapsoriasis/MF.

Preparation and Safety Evaluation of Topical Simvastatin Loaded NLCs for Vitiligo.

Purpose: Vitiligo is a long-term common autoimmune disease in which growing patches of skin lose their color. There is no FDA-approved treatment for vitiligo. However, recent studies have demonstrated an immunosuppressive effect on vitiligo lesions in mouse models by simvastatin. A topical formulation was prepared containing simvastatin-loaded nano lipid carriers (simNLCs) for vitiligo treatment followed by evaluating their physicochemical characteristics and clinical safety. Methods: Both the lipid phase and the aqueous phase were heated to 75°C separately, and then simvastatin was dispersed in the lipid phase added to the aqueous phase. The mixture was homogenized for 1 minute, then for Nanostructured Lipid Carriers (NLC) formation, the emulsion was sonicated using a probe sonicator. The simNLCs produced were evaluated for drug entrapment, particle size and morphology, zeta potential, polydispersity index, viscosity, drug content, in vitro drug release, in vivo skin safety test, and long-term stability studies. Results: Dynamic light scattering, transmission electron microscopy and differential scanning calorimetry techniques proved the formation of a stable formulation containing spherical particles with nanoscale size. The drug entrapment efficiency and the drug-loading capacity were determined to be 99.27% and 3.9%, respectively. Human safety results indicated that adding simvastatin to lipid nanoparticles did not cause any changes to skin biophysical parameters. Conclusion: The preparation method of simNLC developed in this study is a suitable method, and the nanoparticles fabricated were safe with acceptable long-term stability and drug entrapment.

Preparation and evaluation of adapalene nanostructured lipid carriers for targeted drug delivery in acne.

Adapalene (ADA) is believed to be one of the topical treatments utilized commonly in case of acne. Nanostructured lipid carriers (NLCs) have been established as an effective carrier system with certain advantages, for instance increased solubility, drug targeting, controlled drug release, and stability of ADA. This study was conducted to obtain the formulation with a good therapeutic property. All formulations were formed by probe sonicator and its characterizations were analyzed. Finally, the therapeutic effects of 0.1% ADA-loaded nanostructured lipid carriers (NLC-ADA) were evaluated. This formulation had a great entrapment efficiency (EE) that illustrated a controlled drug release profile. A pilot clinical evaluation conducted on 15 patients (age 25.23 ± 12.24 years) with mild to moderate acne vulgaris lesions. The results demonstrated significant reduction in acne severity index and the number of inflammatory and noninflammatory lesions after 12 weeks of treatment (P-value .02, .04, and .01, respectively). Subjective results were confirmed with significant improvement in size and intensity of porphyrin production in pilosebaceous follicles (P-value = .03). The study demonstrated that the formulation was safe and revealed the proper improvement rate of acne lesions after 12 weeks.

Comparison of Urea-Based Compounding Moisturizers and Similar Commercial Products on Skin Barrier Function: A Randomized Biometric Study.

Although several commercial moisturizers are available in the market, the continued role of pharmaceutical compounding has been still felt in dry skin management. This study aimed to evaluate the effect of a ureabased compounded moisturizer on barrier function, compared with a similar commercial product. Thirty volunteers with a mean age of 36.15 ± 9.55 years (range 21-56 years) and dry skin were recruited in two groups, one group to apply 5% urea containing hydrophilic petrolatum and the other 10% urea containing hydrophilic petrolatum. In each cohort, the upper parts of right and left forearms were randomly assigned for twice a day application of commercial or compounded products. Whereas the right lower forearm was assigned for application of a cream-based formulation, the left lower one served as the control site and with application of no topical product. Biophysical assessments [transepidermal water loss (TEWL), skin hydration, friction coeffi cient, pH, and surface lipids], were performed before intervention, at 1 and 4 h after single application, and at 24 h and 1 week twice daily application. In both groups, commercial and compounded moisturizers showed an appropriate and comparable effect on skin barrier function compared with creambased formulation and no treatment area. However, commercial products led to better improvement in TEWL, 4 h after single application in both groups (p-value = 0.04). In case of 10% urea base formulation, the rate of increase in skin hydration was also signifi cantly higher for a commercial emollient than a compounding product (57.48 ± 11.23 vs. 50.59 ± 11.42, p-value = 0.02). Commercial formulation led to higher acceptability and better improvement in the skin barrier function after single application, probably because of the influence of excipients. The present study did not find sufficient added value for cream-based pharmacy product relative to commercial one and suggests to be replaced in a similar condition.

Differentiation of inflammatory papulosquamous skin diseases based on skin biophysical and ultrasonographic properties: A decision tree model.

BACKGROUND: The biophysical and ultrasonographic properties of the skin change in papulosquamous diseases. AIMS: : To identify biophysical and ultrasonographic properties for the differentiation of five main groups of papulosquamous skin diseases. METHODS: Fifteen biophysical and ultrasonographic parameters were measured by multiprobe adapter system and high-frequency ultrasonography in active lesions and normal control skin in patients with chronic eczema, psoriasis, lichen planus, pityriasis rosea and parapsoriasis/mycosis fungoides. Using histological diagnosis as a gold standard, a decision tree analysis was performed based on the mean percentage changes of these parameters [(lesion-control/control) ×100] for differentiation of the diseases. RESULTS: The accuracy of the decision tree model for differentiation of five diseases was 67% which developed based on changes in stratum corneum hydration, epidermal thickness, skin pH, melanin index, R0 (reciprocal of firmness) and erythema. Among the flowcharts for pairs of diseases, three models for differentiation had high accuracy (> 95%): those of psoriasis from lichen planus, pityriasis rosea, and parapsoriasis/mycosis fungoides. LIMITATIONS: Validation studies on a larger sample size in situations where the diagnosis is unclear are needed to confirm the accuracy and applicability of decision trees. CONCLUSION: Skin biophysical and ultrasonographic properties may help in the differentiation of papulosquamous diseases as simple and non-invasive tools.

Comparison of UVA Protection Factor Measurement Protocols.

BACKGROUND: In the past, it was taught that UVA wavelengths (320- 400nm) only plays a major role in skin aging but recently the scientific researches also show that UVA cause cancerous keratinocyte cells in deep layer of the epidermis. Therefore, the protective ability of the product against UVA is important in addition to protection against UVB rays. The UVA protective factor (UVA-PF) is used to evaluate the effectiveness of sunscreen products against UVA rays. This study aims to review and compare all outstanding protocols in the field of UVA-PF measurement and finally the introduction of the best method of measuring UVA-PF based on the further benefits. MATERIALS AND METHODS: Four standards including ISO 24443 (AS/NZS 2604: 2012 recommended approach), CEN 2006, FDA 2007 and FDA 2011 are selected. RESULTS: In order to measure UVA-PF with in vivo method, two standards of CEN 2006 and FDA 2007 recommended persistent pigment darkening (PPD) method. Although the general principle of both is similar, there are some differences in detail. For in vitro measurement of UVA-PF, CEN and FDA 2011 standards use critical wavelengths. FDA 2007 introduces the modified Diffey fraction, and ISO 24443 standard meets the UVA-PF measurement in a manner that is consistent with PPD. CONCLUSION: Finally, this review discussed the comparison of all in vitro and in vivo UVA-PF measurement standards and provided information in the form of texts and tables to move towards the creation of an integrated standard. Since in vitro methods of UVA-PF measurement are not reproducible due to differences in test conditions, it may be concluded that the in vivo PPD method is a more suitable option.

Efinaconazole topical solution 10%: Formulation and efficacy assessment in the treatment of toenail onychomycosis.

BACKGROUND: Efinaconazole is non-lacquer-based with a low surface tension that efficiently targets delivery of active ingredient into the nail and nail bed. OBJECTIVES: To develop an optimal, stable formulation of efinaconazole topical solution 10% (ETS10). METHODS: We evaluated the safety and efficacy of ETS10 on 10 Iranian participants in a pilot, single-group and before-after clinical study, for up to 8 weeks in onychomycosis. RESULTS: The study showed reasonable results concerning the short period of treatment. During the period of storage, the formulation showed no variation in colour, odour and pH. The average pH at initial, 1st, 6th and 12th months was 4.65, 4.64, 4.65 and 4.64, respectively. The assay of an active pharmaceutical ingredient in the formulation was desired over the whole period. This indicates that antimicrobial activity has been adequate and efficient. A significant decrease in Investigator Global Assessment (IGA) of the target toenails was also defined as the efficacy endpoint. The median score for IGA at baseline visit was 3 out of 5 which decreased to 2 out of 5 and the decrease was statistically significant. CONCLUSION: The study clarifies the new efficacy of ETS10 in subjects with onychomycosis and passed the safety study successfully. These properties may develop the potentiality of ETS10 as a good treatment option for patients with onychomycosis.

Preparation and evaluation of anti-wrinkle cream containing saffron extract and avocado oil.

BACKGROUND: Recently, many compounds or extracts from natural sources are used for reducing facial aging and wrinkles. OBJECTIVE: This study investigates the preparation and evaluation of the safety and efficacy of saffron extract and avocado oil used for anti-wrinkle topical cream. METHODS AND MATERIALS: Oil in water cream was prepared containing avocado oil and the saffron extract. Accelerated stability tests were carried out due to 6 months accordingly through the International Council for Harmonization (ICH) guideline. For clinical studies, topical cream was applied by twenty healthy volunteers daily, for 12 weeks. Improvement in wrinkle grading by a Global Aesthetic Improvement Scale (GIAS), depth and volume of the nasolabial fold, thickness, and density of dermis, and determination of the skin biophysical parameters were evaluated at the baseline, 6th and 12th week. RESULT: During the period of storage, the formulation showed no variation in physicochemical properties. The clinical evaluation showed at least one-grade improvement in GIAS in 30% and 45% of participants, after 6 and 12 weeks, respectively. Subjects were "moderately satisfied" with the treatment. In addition, the area and volume of nasolabial folds were significantly reduced. Moreover, net elasticity (R5) and gross elasticity (R2) showed a significant increase after 12 weeks of treatment. There was no report of allergic reactions, and no changes in skin hydration occurred during the treatment. CONCLUSION: The results of this study showed that saffron extract and avocado oil anti-wrinkle topical cream is an efficient and safe treatment for facial skin rejuvenation.

Evaluation of the safety and efficacy of a triple combination cream (hydroquinone, tretinoin, and fluocinolone) for treatment of melasma in Middle Eastern skin.

Background: Melasma is the most common pigmentary skin disorder, especially in females and those with darker complexion. The current study evaluated the safety and efficacy of a triple combination cream containing hydroquinone 4%+tretinoin 0.05%+fluocinolone acetonide 0.01% (Januluma® cream produced by Janus Pharmaceutical Co, Tehran, Iran) in the treatment of melasma. Patients and methods: Twenty-two female volunteers (mean±standard deviation of age: 39.20±4.16 years) who fulfilled the eligibility criteria participated in this study after signing the informed consent. They were requested to apply the Januluma®cream every night for 8 weeks. Modified melasma area and severity index (mMASI), skin lightness (L value), and severity of pigmentation (E value) by Visio Face, and skin biophysical parameters including pH, melanin index, erythema index, sebum, hydration, trans epidermal water loss, thickness and density of epidermis, and dermis (using 22 MHz ultrasonography) were measured before and 4 and 8 weeks after treatment. Also patients' satisfaction was assessed 4 and 8 weeks after treatment using visual analog score. Results: mMASI decreased significantly from 3.37 to 2.60 at week 4, and to 2.40 at week 8 (P-values=0.00 and 0.01, respectively). Also, E and L values improved significantly after 8 weeks of treatment (P=0.01 and 0.00, respectively). Skin melanin index decreased from 237.49 AU to 196.30 AU at week 8 (P=0.01). Also echo density of dermis increased significantly after 8 weeks of treatment (P=0.029). Almost all participants experienced some degrees of pruritus, scaling, and erythema, esspecially during the first month of application, which were generally mild and tolerable. The mean satisfaction of patients with the treatment was 6.77. Conclusion: The triple combination formula was reasonably safe and effective for treatment of melasma in Middle Eastern patients.