ALA-IPL Treatment
Is this combination effective in the treatment of photodamage?
In an effort to prove that pre-treatment with topical 5-aminolevulinic acid (ALA) enhances the effects of intense pulsed light (IPL) treatments for photodamage, 20 Caucasian female patients with moderate photodamage were recruited from a single group practice for a prospective, single-blinded, split-face study. The patients were randomized as to which side of their face would b e treated with ALA-IPL versus IPL alone.

The Study
A single broad-band, filtered, IPL source with a wavelength range of 515 nm to 1200 nm was used to treat all patients. The standard SR head was used. Program 1 was used on the device with the first pulse set at 2.4 msec, the second pulse at 4.0 msec, and a 15 msec delay between pulses. The fluence ranged from 23 J/cm2 to 28 J/cm2. Epidermal cooling with a gel was achieved with the chiller tip set to maximum on the integrated cooling system.
Patients received five treatments (right vs. left), ALA-IPL vs. IPL (day 0, 21, 42), IPL only (day 63, 84) with a final visit (visit nine, day 114). For the ALA-IPL treatments, two coats of
5-ALA solution was applied following a full-face acetone scrub. The ALA was left on for 45 minutes (30 to 60 minute range). After treatment, the patients washed again, applied a sunscreen and were instructed regarding strict sun avoidance and sun protection. Investigators compared the two sides of the face for efficacy of fine lines, mottled pigmentation, tactile roughness and sallowness, as well as a global score for photoaging (0 (none) to 4 (severe)). Side effects of erythema, scaling and dryness, edema and oozing/crusting/vesiculation were graded on a score of 0 (none) to 4 (severe). Stinging/burning was graded on a 0 (none) to 3 (severe) scale. Patient and investigator satisfaction was evaluated at week 16 as excellent, good, fair or poor.

Results
• Global Score for Photoaging: More patients experienced an improved score of at least one grade compared to baseline on the ALA-IPL side versus the IPL alone side after the third (70% vs. 40%, p<0.014), fourth (80% vs. 40%, p<0.005) and fifth treatments (80% vs. 45%, p<0.008). A greater percentage of successful results (defined as a final score of 0 or 1) were achieved on the ALA-IPL side compared to the IPL only side (25% vs. 5%, p=0.046) after the fourth treatment. (See table).
• Fine Lines and Mottled Pigmentation: The ALA-IPL sides had a greater proportion of low scores after the fourth and fifth treatment than the IPL alone side.
• Tactile Roughness and Sallowness: Both groups showed improvement, although pre-treatment with ALA did not appear to enhance the results of IPL.
• Investigator Cosmetic Evaluations and Patient Satisfaction: Both the final investigator cosmetic evaluations and patient satisfaction scores were significantly better for the ALA-IPL treated sides than the IPL only side. For the investigators, 95% of the ALA-IPL treated sides were rated as good or excellent, and 60% of the IPL only sides were rated good and none were rated excellent. For patient satisfaction scores, 95% of the ALA-IPL treated sides versus 70% of the IPL only sides were rated as good or excellent.
• Side Effects: The treatment was
well tolerated and the side effects between the two treatments were not
significantly different.
Poster Authors: JS Dover, AC Bhatia, B Stewart, K Arndt.

New Treatment Guidelines
Evidence-based treatment guidelines for optimizing the effects of ThermaCool device.
An expert panel met to review Thermage results with standardized treatment guidelines, backed up by independent research findings presented at the American Society of Laser Medicine and Surgery (ASLMS) annual meeting this year.
A group of physicians from the fields of dermatology, plastic surgery, facial plastic surgery and oculoplastic surgery evaluated the guidelines for performing this non-invasive procedure to tighten and contour deep tissue. The panel was co-chaired by Drs. Jeffrey Dover and Brian Zelickson.
The panel looked at pooled data reports from 5,700 Thermage patient treatments and assessed satisfactory efficacy in 94% of recently treated cases. Improvements in predictability were directly attributed to following optimized treatment guidelines. They reported that using multiple passes at moderate settings resulted in higher patient satisfaction and improved patient comfort during the procedure.

The Dry Skin Cycle
Researchers develop new model for the science behind dry skin.

Scientists at Procter & Gamble have developed a new model to study the problem of dry skin and to subsequently develop products to counteract it. What resulted was the Dry Skin Cycle (see figure above), a new model that explains the induction and propagation of the dry skin condition in otherwise normal human skin as a cyclical model.
According to Procter & Gamble, when the skin is provoked by one or more of the primary induction mechanisms, a sequence of events, or a cycle, results. This cycle is dependent of the integrity of the stratum corneum. It is particularly dependent on barrier function and homeostasis, which is necessary for controlling stratum corneum water flux, content and enzymatic reactions. The dry skin cycle inhibits the skin’s ability to hydrate itself, renew its outer layers, replenish natural moisturizing factors and repair its moisture barrier. When the moisture barrier is disrupted, researchers found that a “frenzy of skin cell overproduction” happens in order to compensate. The desquamation process slows and produces a thick, dull cell layer.
Procter & Gamble researchers found that intervention at multiple points within the cycle are necessary in order to improve barrier function, normalize desquamation and better prepare the skin for internal and external stress. Paul Matts, Ph.D., the principle researcher at Procter & Gamble, is the author of The Dry Skin Cycle. This cycle has been described in the Dermatology Foundation’s Progress in Dermatology series, Stratum Corneum Moisturization at the Molecular Level: An Update in Relation to the Dry Skin Cycle.

Phase III Data for Isolagen
New 12-month data.
Adouble-blind, placebo-controlled, multi-center trial looked at 151 patients to assess the use of the Isolagen Process, an autologous living fibroblast culture technique developed by Isolagen Technologies Inc., to improve facial contour deformities, including acne, scarring and rhytids. The primary endpoint was at 4 months, with Isolagen treatment offered to placebo patients after 6 months of evaluation. All patients treated with Isolagen were monitored for 12 months after the first injection.
Post-auricular biopsy of skin with a patented method of culturing skin fibroblasts was performed yielding about 20 million cells/cc for injection. Patients received 3 injections of 1 cc of autologous fibroblasts 1 to 2 weeks apart during the treatment phase.

The Results
Efficacy was measured by a 2-point improvement on a 7-point standardized photoguide scale. A global assessment was also made by the patients using a Visual Analog Scale (VAS).
Results showed a significant improvement in rhytids and acne scarring over time. Responders for all treatment areas at 1, 2, 4 and 6 months post-injection were 57%, 79.6%, 77.1% and 82.2%, respectively.
The therapeutic effect of Isolagen compared to placebo was demonstrated at 6 months (82.2% vs. 38.2%, Fisher’s exact, p-value=<0.0001). Results of a 12-month follow-up assessment on the Isolagen group (91 patients) showed the therapeutic effect was maintained with a response rate of 82.4%.

Proven Efficacy
Researchers concluded that autologous living fibroblast injections from cultured skin fibroblasts using a proprietary technique for high yield of living fibroblasts is highly statistically efficacious compared to placebo injections at 6 months. Both acne contour defects and superficial rhytids responded well to this procedure. Response was maintained 12-months post-injection. No serious adverse events related to Isolagen were reported in this study. n

Poster Authors: RA Weiss, MA Weiss, KL Beasley, G Munavalli.

Who’s Seeking Treatment?
Results of survey describe the typical Botox Cosmetic user.
Working mothers between the ages of 40 and 55 are the most common patients seeking treatment with botulinum toxin type A (Botox Cosmetic), according to the results of a study by the Aesthetic Surgery Education & Research Foundation (ASERF), the research arm of the American Society of Aesthetic Plastic Surgery (ASAPS). The survey also found that the most common reason people begin treatment with Botox is to look less stressed and more relaxed.
ASAPS surveyed U.S. physicians performing cosmetic procedures for its annual survey (see “News & Trends” on page 12 for more on this survey) and reported that for the fourth year in a row, Botox injections were the most frequently performed procedure. ASERF conducted a follow-up survey to quantify the characteristics and opinions of patients who receive this treatment.
ASERF used Industry Insight, an independent research and consulting firm, to conduct the survey. A packet of 50 two-page questionnaires was distributed to 1,665 physicians. The physicians distributed the forms, which included business reply envelopes addressed to Industry Insights, to their Botox patients. A total of 1,048 patients responded. The survey was sponsored in part by an unrestricted educational grant from Allergan.

The Survey Says
• 44% have annual household incomes of less than $50,000 to $100,000 and 36% have annual incomes of more than $150,000.
• 86% received injections to treat glabellar lines.
• Of those receiving injections in this area, 52% said they looked “more rested or refreshed,” 49% said they looked “more relaxed,” 45% said they looked “less stressed” and 39% said they looked “less angry or stern.”
• 97% were satisfied with the results of their Botox treatment
• 70% reported they have been using the treatment for 1 to 5 years or longer.
• 64% reported that the cost of their latest treatment was between $250 and $500. n

Treating Solar Lentigines and Post-Inflammatory Hyperpigmenation
A comparison of monotherapy versus combination therapy.
The safety and efficacy of mequinol 2%/tretinoin 0.01% (Solage´) in treating solar lentigines (SL) was proven in two Phase III randomized, placebo-controlled studies of 1,175 patients. Patients in the studies were treated with the combination product, tretinoin alone, mequinol alone or vehicle.
The first trial, which involved 595 adults, was a 24-week treatment phase followed by a 24-week no treatment regression phase. In this trial, 52% and 56% of the group receiving the combination product achieved moderate or better clinical success on the face and forearms, respectively, by physician’s global assessment compared to 35% and 43% in the tretinoin group, 24% and 33% in the mequinol group, and 17% and 19% in the vehicle group (p<=0.002). During the 24-week regression phase, the combination group demonstrated statistically significant superiority (p<=0.003).
The second trial enrolled 580 patients and included a 24-week treatment phase followed by a 4-week no-treatment phase. Mequinol/tretinoin was significantly superior (p<=0.03) by physician’s global assessment on the´ forearm. On the face, it was statistically superior to mequinol alone and to vehicle (p=0.0001) and was directionally superior to tretinoin (57% vs. 48%) in achieving clinical success as defined by moderate improvement of better.
In both studies, most adverse effects were mild to moderate.

Post-Inflammatory Hyperpigmentation
A small, open-label study examined the use of mequinol/tretinoin solution in the treatment of post-inflammatory hyperpigmenation (PIH) in three African-American patients. The solution was applied twice a day to the targeted lesions. By week 6, all three patients showed improvement. By week 12, the PIH was completely resolved for two patients.

Mequinol/Tretinoin and Other Treatments
The combination of procedural and topical therapy is beneficial because the addition of the topical therapy helps maintain remission and adds a continuing depigmenting effect of its owns and helps prevent post-inflammatory hyperpigmenation.
A follow-up study of cryotherapy and local dermabrasion in which there was a 55% recurrence rate for SL following the two treatments, examined mequinol/
tretinoin as an adjunct to trichloroacetic acid peels and cryotherapy in 10 patients with SL.
After 30 days of treatment with 25% to 35% TCA peels/cryotherapy, patients were instructed to apply the combination solution twice per day to the SL on one hand. No sunblock was used. At the 10-month telephone follow-up, one patient noted complete improvement with the topical/procedural therapy and with the procedural therapy alone on the other, while three patients noted 90% improvement, two noted 80% improvement and one noted 10% improvement. Results from two patients were unavailable.
One open-label study examined the use of “puff” cryotherapy using the brush technique followed by mequinol/tretinoin topical solution. The study involved 24 Caucasian patients with at least three SL that were moderately darker than the surrounding skin. The cryotherapy was delivered by means of a special spray tip that lightly painted the whole dorsa of the hand, rather than individual lesions. The thaw time was 1 to 2 seconds. Cryotherapy was following with twice-daily application of the mequinol/tretinoin solution for 6 weeks, and the topical therapy continued for another 6 weeks. At week 6, 15 patients showed moderate improvement, two showed marked improvement and six showed minimal improvement.
From preliminary studies, researchers have found mequinol/tretinoin solution to be an adjunct to cryotherapy in the management of SL. It helps to enhance the effects of cryotherapy as well as maintain remission.

Poster Authors: Daniel Piacquadio, M.D., Francis Cook-Bolden, M.D. Jeanine B. Downie, M.D., F.A.A.D., Patricia Farris, M.D., F.A.A.D., Patricia Farris, M.D., P.A.A.D., Marta Rendon, M.D., Stacy Smith, M.D.