PCCA PracaSil™-Plus

Case Study 1: Basal Cell Carcinoma Post-Surgical Scar

Summary:

Basal cell carcinoma is a type of skin cancer that often leads to surgical excision of the affected area, which results in destruction of the tissues and skin scarring. The purpose of this case study is to discuss the management of a basal cell carcinoma post-surgical scar using PracaSil-Plus in a 41-year-old Caucasian male. The POSAS Patient Scale (adapted) was the research instrument used to evaluate the efficacy of PracaSil-Plus in scar management therapy. Following PracaSil-Plus treatment, the total POSAS score decreased by 33 and the patient’s overall opinion by 6, corresponding to improvements of 76.7% and 75.0%, respectively. The post-treatment scar was no longer painful or itchy and all other parameters (colour, stiffness, thickness and irregularity) were very similar to normal skin, which demonstrates a successful recovery process and a considerable improvement in the patient’s quality of life.

Introduction:

Basal cell carcinoma (BCC) is a type of skin cancer that arises from the uncontrolled growth of basal cells lining the deepest layer of the epidermis. There is a high incidence of BCC as over 2 million people are estimated to be diagnosed with BCC every year in the United States, with a higher prevalence in the Caucasian population [1, 2]. The etiology of BCC is usually associated with exposure to ultraviolet radiation in sunlight. Following diagnosis, surgical excision of the cancerous cells is the most common treatment option [2]. Surgical excision can result in destruction of the tissues, leading to scarring and disfigurement. Unfortunately, scars cannot yet be made to disappear, and may range from a desirable fine line to a variety of abnormal scars, including hypertrophic and keloid scars. Taking into account that clinical treatments do not entirely eliminate skin scarring, the therapeutic goal is to reduce, as much as possible, the severity of the scars [3-5].

The purpose of this case study is to discuss the management of a basal cell carcinoma post-surgical scar using PracaSil-Plus, a topical silicone base containing Pracaxi oil, used alone or in combination with active pharmaceutical ingredients in scar management therapy [6].

Methodology:

A 41-year-old Caucasian male with no significant underlying medical conditions was diagnosed with basal cell carcinoma, presented as a solitary patch at the tip of his nose. Following diagnosis, tumor cells were removed with surgical excision of the affected area. Graft skin was taken from the patient’s forehead to patch the tip of his nose. The patient was then instructed by his physician to use Bactroban™ ointment for 5 days until the wound closed. Following wound closure, the patient was instructed to apply PracaSil-Plus to the affected area, one to two times a day. The patient was asked to obtain standardiszed digital images of the affected area before and after treatment with PracaSil-Plus.

The Patient and Observer Scar Assessment Scale (POSAS) v2.0/EN, in particular the POSAS Patient Scale (adapted), was the research instrument used to evaluate the efficacy of PracaSil-Plus in scar management therapy. The POSAS Patient Scale is a validated scar assessment instrument designed for a subjective evaluation of various types of scars directly by the patients. It is commonly used in clinical practice as it has shown good internal consistency, reliability and agreement. The POSAS Patient Scale contains seven items that are scored numerically on a Likert scale from 1 (normal skin) to 10 (worst scar). The first six items refer to the following scar parameters: pain and itching (scar sensation); colour; stiffness; thickness and irregularity (scar appearance). The last parameter rates the patient’s overall opinion of the scar when compared to normal skin. The numerical rating is obtained by adding the scores of the six parameters (range 6 to 60), in addition to the overall score (range 1 to 10). The higher the scores obtained, the worse the scar quality [7].

The patient was asked to complete the POSAS Patient Scale retrospectively by rating his basal cell carcinoma post-surgical scar, before and after treatment with PracaSil-Plus. Written informed consent was obtained from the patient for publication of this case study and the accompanying digital images.

Results and Discussion:

The patient completed all parameters of the POSAS adapted scale, as displayed in Table 1. The patient also shared the digital images of the affected area, before and after treatment with PracaSil-Plus (Figures 1–-3).

Before treatment with PracaSil-Plus, the total score of the first six items was 43 which suggests a poor quality scar, very different from normal skin. For sensation, the patient rated the scar to be painful (n=8) and itchy (n=7). For appearance, higher (worst) scores were obtained for scar colour (n=9) and stiffness (n=9), whereas lower scores were obtained for scar thickness (n=4) and irregularity (n=6). The overall opinion was rated 8 (range 1 to 10) which also suggests a poor quality scar, very different from normal skin.

After treatment with PracaSil-Plus, the total score of the first six items was 10 (range 6 to 60) which suggests a very good quality scar. The total score decreased by 33, from 43 (pre-treatment) to 10 (post-treatment), corresponding to an improvement of 76.7% in relation to scar sensation and appearance.

Figure 3. Digital image of scar 11 months post-surgery.

Figure 1. Digital image of post-surgical scar before treatment with PracaSil-Plus.

Figure 2. Digital image of scar 2 months post-treatment with PracaSil-Plus.

The scar was no longer painful (n=1) or itchy (n=1) and all other parameters (colour, stiffness, thickness and irregularity) were very similar to normal skin (n=2). The patient’s overall opinion decreased by 6, from 8 (pre- treatment) to 2 (post-treatment), corresponding to an overall improvement of 75.0%, as displayed in Table 1.

Table 1. POSAS parameters and corresponding patient’s scores, before and after treatment with PracaSil-Plus.

Conclusions:

Skin scarring is often considered trivial but may also be aesthetically unpleasant and disfiguring, causing distress, anxiety and other psychosocial consequences. Scars may also have physical consequences such as tenderness, itching and pain, which are functionally disabling and can contribute to diminished quality of life [3–6]. Scar management therapy is therefore an essential component in the post-surgical recovery process.
This case study has demonstrated that PracaSil-Plus, a topical silicone base containing Pracaxi oil, is effective in scar management therapy. The POSAS patient scores showed a significant reduction of all scar parameters, from scar sensation (pain and itching) to scar appearance (colour, stiffness, thickness and irregularity), indicating significant improvements in scar quality following PracaSil- Plus treatment. The highest improvements were noticed in pain (87.5%) and itching (85.7%), which are the parameters that are likely to have the greatest impact on the patient’s quality of life. The total POSAS score and the patient’s overall opinion also showed considerable improvements in scar quality (76.7% and 75.0%, respectively). The patient rated his basal cell carcinoma post-treatment scar as very similar to normal skin (n=2), which demonstrates a successful recovery process and a considerable improvement in the patient’s quality of life. PracaSil-Plus may then be recommended by compounding pharmacists as the treatment of choice in scar management therapy.

References:
1. Fung K, Suhail M, McClendon B, Woolley C, Young D, Lin H. Management of basal cell carcinoma of the skin using frankincense (boswellia sacra) essential oil: a case report. OA Alternative Medicine 2013; 1 (2): 1-5.
2. Jadotte Y, Sarkissian N, Kadire H, Lambert W. Case report: superficial spreading basal cell carcinoma of the face: a surgical challenge. Open Access Journal of Plastic Surgery 2010; 10: 394-8.
3. Bayat A, McGrouther D, Ferguson M. Skin scarring. BMJ 2003; 326: 88-92.
4. Bayat A, McGrouther D. Spectrum of abnormal skin scars and their clinical management. Br J Hosp Med 2006; 67 (10): 527-32.
5. Brown B, Moss T, McGrouther D, Bayat A. Skin scar pre-conceptions must be challenged: Importance of self-perception in skin scarring. Journal of Plastic, Reconstructive & Aesthetic Surgery 2010; 63 (6): 1022-9.
6. Banov D, Banov F, Bassani A. Case series: the effectiveness of fatty acids from pracaxi oil in a topical silicone base for scar and wound therapy. Dermatol Ther 2014; 4 (2): 259-69.
7. van de Kar A, Corion L, Smeulders M, Draaijers L, van der Horst C, van Zuijlen P. Reliable and feasible evaluation of linear scars by the patient and observer scar assessment scale. Plastic and Reconstructive Surgery 2005; 116 (2): 514- 22.

Case Study 2: Ulcerated Leg Wound

Summary:

A compounded medicine using PracaSil-Plus (PCCA Formula #10843) was applied topically in an open wound located on the leg of a diabetic patient, with outstanding healing results.

Case Description:

A 61-year-old Caucasian male with type 2 diabetes, a sedentary lifestyle and an occupation that involves a seated position, presented with a 4 mm (approx.) diameter ulcer on his inner leg, from 8 to 10 mm above the right ankle (Figure 1). Treatment was initiated using a compounded medicine containing mupirocin 2% in PracaSil-Plus (Figure 2), which was applied topically to the ulcer three times daily. A second compounded medicine containing pentoxifylline 3% and nifedipine 3% in Lipoderm™ (Figure 3) was applied topically to the marginal area of the ulcer, also three times daily, in order to increase blood circulation. The patient was instructed to exercise every hour using an elastic band, also to improve blood flow to the ulcerated area. The wound was closed following 63 days of treatment (Figure 4).

Patient Report: I developed an open wound on my right ankle. Everything that I was asked to do by my doctor didn’t work and the wound was actually getting worse. A compounding pharmacist suggested two compounded medicines to be applied daily. In two months, my open wound was closed and the pain was gone. The treatment worked as promised.

Figure 4. Ulcerated Leg Wound (after PracaSil-Plus formula).

Figure 1. Ulcerated Leg Wound (before PracaSil-Plus formula).

Figure 2. PCCA Formula #10843

Figure 3. PCCA Formula #10844

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Acknowledgements: The patient agreed to anonymously share information and figures included in this case study. Figures 1 and 4 are courtesy of the patient. PCCA Science is grateful for the valuable information shared.

Introduction:

PracaSil-Plus is a proprietary anhydrous silicone base designed to be applied topically in scar therapy treatment (PCCA, 2013a). Silicones have been widely used for their occlusion and hydration properties, which are essential in scar management (Widgerow et al., 2000; Mustoe, 2008). PracaSil-Plus also contains Pracaxi oil, extracted from the oilseed plant Pentaclethra macroloba, which has several medicinal applications including skin regeneration and healing (Costa et al., 2013). PracaSil-Plus may be used alone or as a base for the incorporation of active substances in scar therapy treatment (PCCA, 2013a).

Research Studies:

The efficacy of PracaSil-Plus in scar therapy treatment was evaluated by visual and instrumental methods in an eight-week, randomised, double-blind, controlled pilot trial conducted on eleven adult Caucasian subject volunteers. PracaSil-Plus showed qualitative and quantitative improvements in the following scar attributes: scar length, scar colour/pigment intensity, scar texture/ smoothness/roughness, and overall appearance in both old scars and new scars (PCCA, 2013b).

References:
Costa, M., Muniz, M., Negrao, C., Costa, C., Lamarao, M., Morais, L., Junior, J. and Costa, R. (2013) ‘Characterization of Pentaclethra macroloba oil’, Journal of Thermal Analysis and Calorimetry, 16 January 2013 [Online].
Mustoe, T. (2008) ‘Evolution of silicone therapy and mechanism of action in scar management’, Aesthetic Plastic Surgery, 32 (1), p.82-92.
PCCA (2013a) PracaSil-Plus. Available at: http://www.pccarx.com/pcca-products/pcca- exclusives/bases/PracaSil-plus (Accessed: 17 May 2013).
PCCA (2013b) ‘Efficacy of PracaSil-Plus in scar therapy treatment: a randomized, double-blind, controlled pilot trial’, Technical Report: 2TR0513.
Widgerow, A., Chait, L., Stals, R. and Stals, P. (2000) ‘New innovations in scar management’, Aesthetic Plastic Surgery, 24 (3), p.227-234.