Clinical Trials

Stratpharma develops ambitious clinical plans to fulfill health care professionals’ expectations and patients’ needs.

Stratpharma has a dedicated team focused on developing new therapies and pioneering technologies within our core specialties.
We challenge current standard treatment paradigms through an ambitious clinical development program aimed at advancing medical care and improving patient outcomes.
Stratpharma continuously invests in developing an ambitious clinical plan to fulfill health care professionals’ expectations and patient needs.

Latest clinical results and publications

Stratpharma has conducted numerous clinical studies over the years. Check the latest clinical evidence and results supporting our products.

All Strataderm clinical publications

McPhail, S. M., Wiseman, J., Simons, M., Kimble, R., & Tyack, Z. (2022). Cost-effectiveness of scar management post-burn: a trial-based economic evaluation of three intervention models. Scientific reports, 12(1), 18601. https://doi.org/10.1038/s41598-022-22488-3

Wiseman, J., et al. (2021). Clinical Rehabilitation, doi: 10.1177/0269215519877516, Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management. 

Khalil, Ereny & Hamada, Hamada & El Khatib, Ayman. (2019). Effect of silicone gel versus Contractubex or corticosteroid phonophoresis for post-burn hypertrophic scars: A single-blind randomized controlled trial. Fizjoterapia. 27. 1-5. 10.5114/pq.2019.83054. 

Marini, L., Odendaal, D., & Smirnyi, S. (2017). Importance of Scar Prevention and Treatment-An Approach From Wound Care Principles. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 43 Suppl 1, S85–S90. https://doi.org/10.1097/DSS.0000000000001001

Grigorovici, Alexandru & Mirela, Sanda & Cherciu, & Popescu, Cătălin & Gabriela, Delia & Apostol, Ciobanu & Preda, Cristina & Călin, Alina & Petruta, Aelenei. (2017). Efficacy and safety of regen-sil® in post-operative scars management. 65. 

Gold, M. H., Berman, B., Clementoni, M. T., Gauglitz, G. G., Nahai, F., & Murcia, C. (2014). Updated international clinical recommendations on scar management: part 1–evaluating the evidence. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 40(8), 817–824. https://doi.org/10.1111/dsu.0000000000000049

Gold, M. H., McGuire, M., Mustoe, T. A., Pusic, A., Sachdev, M., Waibel, J., Murcia, C., & International Advisory Panel on Scar Management (2014). Updated international clinical recommendations on scar management: part 2–algorithms for scar prevention and treatment. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 40(8), 825–831. https://doi.org/10.1111/dsu.0000000000000050

 

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All Stratamed clinical publications

Poelchow, F., Codde, J., Kendell, R., Edgar, D. W., & Wood, F. M. (2024). A randomised investigation of film-forming silicone gel in superficial partial thickness face and neck burn patients: Indication of improved early scar pigmentation outcomes. Burns : journal of the International Society for Burn Injuries, 50(6), 1605–1613. https://doi.org/10.1016/j.burns.2024.03.024

Abedini, F., Mohammadi, S. R., Dahmardehei, M., Ajami, M., Salimi, M., Khalandi, H., Mohsenzadegan, M., Seif, F., Shirvan, B. N., Yaalimadad, S., Roudbary, M., & Rodrigues, C. F. (2022). Enhancing of Wound Healing in Burn Patients through Candida albicans β-Glucan. Journal of Fungi, 8(3), 263. https://doi.org/10.3390/jof8030263 

James, I. B., Turer, D. M., & DiBernardo, B. E. (2021). Comparison of a Novel Silicone Gel Wound Dressing vs Bacitracin After Follicular Unit Extraction Hair Transplantation. Aesthetic surgery journal. Open forum, 4, ojab051. https://doi.org/10.1093/asjof/ojab051

Misitzis, A., Bhargava, S., Cunha, P. R., & Kroumpouzos, G. (2022). Aminolevulinic Acid-Photodynamic Therapy for Erosive Pustular Dermatosis of the Scalp: Comparison of Two Treatment Protocols and Participant Satisfaction. Skinmed, 20(2), 107–112.

Negbenebor, N. A., Shayegan, L. H., Cohen, L. M., & Kroumpouzos, G. (2022). Nonmelanoma skin cancer in the setting of erosive pustular dermatosis of the scalp: A case series and comment on management implications. Dermatologic therapy, 35(7), e15584. https://doi.org/10.1111/dth.15584

Benedetto, A. V., Staidle, J. P., Schoenfeld, J., Benedetto, E. A., & Benedetto, P. X. (2021). Comparing the use of a novel antibiotic-free film-forming topical wound dressing versus a topical triple antibiotic in dermatologic surgical procedures including Mohs micrographic surgery. Journal of the European Academy of Dermatology and Venereology : JEADV, 35(1), 247–255. https://doi.org/10.1111/jdv.16965

Lucattelli, E., Cipriani, F., Pascone, C., & Di Lonardo, A. (2021). Non-Healing Burn Wound Treatment With A Sterile Silicone Gel. Annals of burns and fire disasters, 34(1), 53–57.

Rancour, E. A., Wehlage, K. M., Kuhar, M., & Somani, A. K. (2021). Unusual Calcification Mimicking Periosteal Tumor Invasion in a Squamous Cell Carcinoma Treated With Mohs Micrographic Surgery. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 47(4), 545–547. https://doi.org/10.1097/DSS.0000000000002410

Bleasdale, B., Finnegan, S., Murray, K., Kelly, S., & Percival, S. L. (2015). The Use of Silicone Adhesives for Scar Reduction. Advances in wound care, 4(7), 422–430.

Shino Bay Aguilera DO FAAD,a Irene De La Peña MD,b Martha Viera MD FAAD,c Bertha Baum DO FAAD FAOCD,d Brian W. Morrison MD FAAD,e Olivier Amar MD ASPS BAPRAS SOF. CPRE,f Matthieu Beustes-Stefanelli MD MBA,g Mehreen Hall DOh. 2020. The Impact of COVID-19 on the Faces of Frontline Healthcare Workers.

Boehm, Kaitlin & Avashia, Yash & Savetsky, Ira. (2020). Laser Resurfacing: Safety and Technique. Plastic and Reconstructive Surgery – Global Open. 8. 1. 10.1097/GOX.0000000000002796. 

Optimising scar outcome through the use of a silicone-based film-forming wound dressing: A pilot study on post-burn healing. Fiona Poelchow 1,2, Rosemary Kendell2, Associate Professor Dale Edgar1,2,4,5, Winthrop Professor Fiona Wood1,2,3, Professor Jim Codde3 State Adult Burns Unit, Fiona Stanley Hospital, Perth, Western Australia

Benedetto A. V. (2019). What’s New in Cosmetic Dermatology. Dermatologic clinics, 37(1), 117–128. https://doi.org/10.1016/j.det.2018.08.002

Raventós, X. C., Flores Climente, V. A., García Navarro, X., Perez Gil, A., Salido Vallejo, R., & Vázquez Doval, F. J. (2019). Efficacy of an Innovative Film-Forming Wound Dressing on Open Wounds. Skinmed, 17(5), 298–304.

Cunha, P. R., Tsoukas, M. M., & Kroumpouzos, G. (2019). Erosive Pustular Dermatosis of the Scalp Treated With Aminolevulinic Acid Photodynamic Therapy and Postprocedure Silicone Gel. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 45(5), 740–743. https://doi.org/10.1097/DSS.0000000000001664

Gold, M. H., Biron, J., & Thompson, B. (2019). Randomized, single-blinded, crossover study of a novel wound dressing vs current clinical practice after percutaneous collagen induction therapy. Journal of cosmetic dermatology, 18(2), 524–529. https://doi.org/10.1111/jocd.12872

Sandhofer, M., & Schauer, P. (2012). The safety, efficacy, and tolerability of a novel silicone gel dressing following dermatological surgery. Skinmed, 10(6), S1–S7.

Yong, A. A., & Goh, C. L. (2018). Use of silicone gel to enhance skin wound healing by secondary intention following tumour excision on the scalp and extremities. Clinical and experimental dermatology, 43(6), 723–725. https://doi.org/10.1111/ced.13571

Marini, L., Odendaal, D., & Smirnyi, S. (2017). Importance of Scar Prevention and Treatment-An Approach From Wound Care Principles. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 43 Suppl 1, S85–S90. https://doi.org/10.1097/DSS.0000000000001001

Uva, L., Aphale, A. N., Kehdy, J., & Benedetto, A. V. (2016). Erosive pustular dermatosis successfully treated with a novel silicone gel. International journal of dermatology, 55(1), 89–91. https://doi.org/10.1111/ijd.13066

Monk, E. C., Benedetto, E. A., & Benedetto, A. V. (2014). Successful treatment of nonhealing scalp wounds using a silicone gel. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 40(1), 76–79. https://doi.org/10.1111/dsu.12366

Sandhofer, M., & Schauer, P. (2012). The safety, efficacy, and tolerability of a novel silicone gel dressing following dermatological surgery. Skinmed, 10(6), S1–S7.

All Stratacel clinical publications

Levy, T., Lerman, I., Waibel, J., Gauglitz, G. G., Clementoni, M. T., Friedmann, D. P., Duplechain, K., Peng, P., Lim, D., Al-Niaimi, F., Lin, S., Munavalli, G., Biesman, B. S., Goodman, G. J., Fratila, A., Beachkofsky, T. M., Ross, E. V., Hussein, A., Kauvar, A., Kilmer, S. L., … Artzi, O. (2025). Expert Consensus on Clinical Recommendations for Fractional Ablative CO2 Laser, in Facial Skin Rejuvenation Treatment. Lasers in surgery and medicine, 57(1), 15–26. https://doi.org/10.1002/lsm.23850

Angra, K., Lipp, M. B., Sekhon, S., Wu, D. C., & Goldman, M. P. (2021). Review of Post-laser-resurfacing Topical Agents for Improved Healing and Cosmesis. The Journal of clinical and aesthetic dermatology, 14(8), 24–32.

Yeh, L. C., Gonzalez, N., & Goldberg, D. J. (2019). Comparison of a novel wound dressing vs current clinical practice after laser resurfacing. Journal of cosmetic dermatology, 18(4), 1020–1024. https://doi.org/10.1111/jocd.13017

Gold, M. H., Biron, J., & Thompson, B. (2019). Randomized, single-blinded, crossover study of a novel wound dressing vs current clinical practice after percutaneous collagen induction therapy. Journal of cosmetic dermatology, 18(2), 524–529. https://doi.org/10.1111/jocd.12872

Gold. (2018). What’s new in treating hypertrophic scars and keloids? THE PMFA JOURNAL VOLUME 5 ISSUE 5 JUNE/JULY 2018

Marini, L., Odendaal, D., & Smirnyi, S. (2017). Importance of Scar Prevention and Treatment-An Approach From Wound Care Principles. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 43 Suppl 1, S85–S90. https://doi.org/10.1097/DSS.0000000000001001

Marini L. (2018). Advanced film-forming gel formula vs spring thermal water and white petrolatum as primary dressings after full-face ablative fractional CO2 laser resurfacing: a comparative split-face pilot study. Journal of the European Academy of Dermatology and Venereology : JEADV, 32(1), 113–116. https://doi.org/10.1111/jdv.14446

All StrataXRT clinical publications

Kennedy, S. K. F., Gojsevic, M., Rajeswaran, T., Zhang, L., Kuszaj, O., Day, M., Karam, I., Vesprini, D., Leung, E., Szumacher, E., Rakovitch, E., Soliman, H., Chen, H., Lee, S. F., Behroozian, T., Tran, W., Wronski, M., Gallant, F., Carothers, K., Yewhans, T., … Chow, E. (2024). StrataXRT for the prevention of acute radiation dermatitis in breast cancer: a pilot study. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 32(10), 670. https://doi.org/10.1007/s00520-024-08851-2

Hush, J. M., Steffens, D., & Solomon, M. J. (2024). A patient-designed integrative oncology intervention for stage IV locally recurrent rectal cancer: A case report. Explore (New York, N.Y.), 20(5), 103004. https://doi.org/10.1016/j.explore.2024.05.002

Lee, S. F., Shariati, S., Caini, S., Wong, H., Chan, A. W., Gojsevic, M., Ogita, M., Ye, J. C., Chia, D., Chao, M., Sung, K., Kennedy, S. K. F., Rajeswaran, T., van den Hurk, C., Wolf, J. R., Chan, R. J., Behroozian, T., Bonomo, P., & Chow, E. (2023). StrataXRT for the prevention of acute radiation dermatitis in breast cancer: a systematic review and meta-analysis of randomized controlled trials. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 31(9), 515. https://doi.org/10.1007/s00520-023-07983-1

Omidvari, S. , Eskandari, Z. , Nasrollahi, H. , Ahmadloo, N. , Ansari, M. , Hamedi, S. H. , Khanjani, N. , Kadkhodaei, B. , Mosalaei, A. and Mohammadianpanah, M. (2022). The Investigation of Prophylactic Effect of StrataXRT Gel on Radiation-Induced Dermatitis in Breast Cancer Patients: A Randomized Clinical Trial. Middle East Journal of Cancer, 13(2), 293-298. doi: 10.30476/mejc.2021.86775.1372

Ahn, S., Sung, K., Kim, H. J., Choi, Y. E., Lee, Y. K., Kim, J. S., Lee, S. K., & Roh, J. Y. (2020). Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial. In vivo (Athens, Greece), 34(1), 413–422. https://doi.org/10.21873/invivo.11790

Raymond J. Chan, Rae Blades, Lee Jones, Tai-Rae Downer, Samuel C. Peet, Elise Button, David Wyld, Steven McPhail, Melissa Doolan, Patsy Yates, A single-blind, randomised controlled trial of StrataXRT® – A silicone-based film-forming gel dressing for prophylaxis and management of radiation dermatitis in patients with head and neck cancer, Radiotherapy and Oncology, Volume 139, 2019, Pages 72-78, ISSN 0167-8140, https://doi.org/10.1016/j.radonc.2019.07.014.

Chan, R. J., Blades, R., Jones, L., Downer, T. R., Peet, S. C., Button, E., Wyld, D., McPhail, S., Doolan, M., & Yates, P. (2019). A single-blind, randomised controlled trial of StrataXRT® – A silicone-based film-forming gel dressing for prophylaxis and management of radiation dermatitis in patients with head and neck cancer. Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 139, 72–78. https://doi.org/10.1016/j.radonc.2019.07.014

Quilis, Amparo & Martín, Jaime & Rodríguez, Concepción & Sánchez, Purificación & Ribes, Juan. (2018). Reducing radiation dermatitis during ongoing radiation therapy: an innovative film-forming wound dressing. Journal of Radiation Oncology. 7. 10.1007/s13566-018-0356-5. 

“The Use of an Innovative Film-Forming Wound Dressing in the Treatment of Radiation Dermatitis during Concomitant Chemotherapy”
 written by Iratxe Arranz Villandiego, Sara Gonzalez Aramberri,
published by Journal of Cancer Therapy, Vol.9 No.12, 2018

Stratpharma ongoing clinical trial

Stratpharma is participating and sponsoring clinical trials in many places globally. Discover the different global clinical initiatives:

Europe

Stratamed and Stratacel - Mode of action on the healing

Trial objective:To evaluate the mode of action of Stratamed on the healing of microscopic treatment zones (MTZs)

Location: Switzerland

Status: Ongoing and still enrolling

More Information: Contact us

StrataCTX - Efficacy in the management of Atopic Reactions

Trial objective:Assess whether StrataCTX® can prevent and treat dermatitis. UV-light will damage the skin mimicking dermatitis (potentially radiation derived).

Location: Switzerland, University of Geneva.

Status: Discussion stage

More Information: Contact us

StrataCTX - DERMA-CTX

Trial objective: Assess whether StrataCTX® can provide symptomatic and clinical relief for AD-related lesions and serve as a supportive therapy for areas typically treated with topical steroids.

Location: Italy, Switzerland

Status: Planning stage

More Information: Contact us

StrataXRT - in use for head & neck cancer

Trial objective: To evaluate the efficacy of StrataXRT® compared to standard of care (SoC) in prevention of acute radiation dermatitis (ARD) in patients undergoing radiotherapy (≥50 Gy) for head and neck.

Location: Cyprus / Greece / Italy

Status: Planning Stage

More Information: Contact us

StrataXRT - for the use in skin, anal, gynaecological cancer – Pilot Study

Trial objective: To evaluate the efficacy of StrataXRT® in prevention of acute radiation dermatitis (ARD) in patients undergoing radical radiotherapy for anal cancer

Location: Cyprus / Greece / Italy

Status: Planning Stage

More Information: Contact us

North America

StrataMGT - VITAL-E clinical trial

Key objective: To assess the efficacy of StrataMGT vs. topical estrogen in the management of atrophic vaginitis.

Site: Orange Coast Women’s Medical Group (CA)

More information: Clinical Trials.gov ID: NCT05672901

StrataMGT - VALOR clinical trial

Key objective: Case series to explore the efficacy of StrataMGT in the management of various mucosal skin conditions (Atrophic Vaginitis, Lichen Sclerosus, Lichen Simplex Chronicus, Lichen Planus) over 12 months (long-term).

Site: Multi-center

More information: Clinical Trials.gov ID: NCT05953090

StrataMGT - DISCO-VLS clinical trial

Trial objective: An open-label exploratory study assessing the effectiveness and safety of StrataMGT in treating vulvar lichen sclerosus. This study enrolls five participants for an 8-week treatment period, with evaluations including biopsy assessments at the beginning and end.

Location: Centers for Vulvovaginal Disorder, New York 10036, USA

Status: Ongoing

More information: Clinical Trials.gov ID: NCT06360705

StrataMGT - ASSIST-VLA clinical trial

Trial objective: A pivotal study assessing StrataMGT’s effectiveness in reducing symptoms of vulvar lichen sclerosus. This randomized, double-blind, placebo-controlled trial will track participants over a 12-week treatment period, measuring quality of life and symptom severity through established dermatological scales.

Location: Multi-center

Status: Ongoing

More information: Contact us

StrataCTX - as steroid sparing agent for cutaneous t-cell lymphoma treatment

Trial objective: StrataCTX as steroid sparing agent for cutaneous t-cell lymphoma treatment

Location: USA

Status: Ongoing and still enrolling

More Information: ClinicalTrials.gov ID NCT03394417

StrataXRT - for the use in skin, anal, gynaecological cancer – Pilot Study

Trial objective: To evaluate the efficacy of StrataXRT® in prevention of acute radiation dermatitis (ARD) in patients undergoing radical radiotherapy for anal cancer

Location: Canada

Status: Planning Stage

More Information: Contact us

South America

Asia

StrataXRT - vs Standard Clinical Practice

Trial objective: Prevention of Acute Dermatitis in Patients Receiving Concurrent Chemoradiation (cisplatin or carboplatin) compared to Standard Clinical Practice.

Location: China / Singapore

Status: Ongoing and still enrolling

More Information: ClinicalTrials.gov ID NCT03394417

StrataXRT - in use for head & neck cancer

Trial objective: To evaluate the efficacy of StrataXRT® compared to standard of care (SoC) in prevention of acute radiation dermatitis (ARD) in patients undergoing radiotherapy (≥50 Gy) for head and neck.

Location: Iran / Hong Kong

Status: Planning Stage

More Information: Contact us

StrataXRT - for the use in skin, anal, gynaecological cancer – Pilot Study

Trial objective: To evaluate the efficacy of StrataXRT® in prevention of acute radiation dermatitis (ARD) in patients undergoing radical radiotherapy for anal cancer

Location: Iran

Status: Planning Stage

More Information: Contact us

Oceania

StrataCTX - for prevention of skin injuries in neonates

Trial objective: To explore the benefits of the silicone gel products in protecting the sensitive skin of neonates.

Location: Australia

Status: Ongoing and still enrolling

More Information: ACTRN12625000441415

StrataCTX - DERMA-CTX

Trial objective: Assess whether StrataCTX® can provide symptomatic and clinical relief for AD-related lesions and serve as a supportive therapy for areas typically treated with topical steroids.

Location: Australia

Status: Planning stage

More Information: Contact us

Stratamark - Prevention and Reduction of Incidence of Marks in Expectant Mothers (PRIME Mothers Trial)

Trial objective: To evaluate the efficacy of Stratamark in preventing stretch marks during pregnancy and in the postpartum period, up to and including after delivery.

Location: Australia

Status: Planning stage

More Information: Contact us

StrataMGT - NICE-940: Non-Inferiority Comparison of Estrogen and 940

Trial objective:To evaluate the non-inferiority of StrataMGT® compared to estrogen cream in terms of safety and efficacy for the treatment of vaginal atrophy.
Replication (open label) of the VITAL-E design

Location: Australia

Status: Planning stage

More Information: Contact us

Africa

Investigator initiated trials

Empowering independent research to advance medical innovation.

Stratpharma supports investigator-initiated trials (IITs) that foster innovation and explore new clinical opportunities. Each IIT must pursue a clear scientific or medical goal, follow a robust study design, and obtain ethics review board approval.

These studies—whether clinical or pre-clinical—may be conducted with Stratpharma’s funding, products, or both, under formal agreements that ensure full compliance with ethical and regulatory standards.

Participating in Stratpharma clinical trials

The involvement of volunteers is fundamental for the success of clinical trials.
Volunteers signing up for a clinical trial will have the chance to receive new innovative treatments.

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