Photoaging Treatment With Imiquimod

NCT01935310 | Completed DMC

• 1 other identifier: IMQ003
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Recently it was demonstrated that imiquimod in addition to exerting a repairing effect in pre malignant and malignant lesions caused by UV radiation it reverses histopathological changes associated with the photoaging skin. This is an experimental exploratory study. It included 17 patients. The patients were diagnosed with photoaging grades III and IV in the scale of Glogau and volunteered to participate in the study. Patients were treated with imiquimod 5% topically, for a time period of 12 weeks. Biopsies were taken from periorbital skin area at baseline and after 4 weeks after completing the treatment. Adverse effects, adherence to therapy and patients' satisfaction were measured. Clinical and histological parameters of photoaging were studied at baseline and after treatment. After completion of treatment with imiquimod, the final clinical evaluation was compared to the initial one.

Conditions

Photoaging

Keywords

Photoaging; imiquimod; wrinkles; elastosis

Outcome Measures

Primary Outcomes (1)

• Evaluation of clinical response by percentage of improvement

  To determine the degree of patient improvement percentages were set according to the values obtained in the first and last measurement as follows: For ordinal clinical variables that had 4 categories the following percentages were established: Slight 1-point improvement (1-32%), moderate 2-point improvement (33-66%), good 3-point improvement (\> 66%), same or worse, one or more points of deterioration (\<= 0%). For ordinal histological variables that were 4 categories the calculated improvement percentages were equal to the ones just described and for those with 5 variables, the established percentages were as follows: Slight 1-point improvement (1-25%), moderate 2-point improvement (26-50%), good 3-point improvement (51-75%), excellent 4-point improvement (\> 75%), one or more points of deterioration (\<= 0%).

  8 weeks

Study Arms (1)

imiquimod use in photoaging

EXPERIMENTAL

Evaluate the efficacy and safety of imiquimod as a treatment option for photoaging photoaging equal to or greater than 3.

Drug: Imiquimod

Interventions

Imiquimod DRUG

From the group of subjects who met the inclusion criteria, 22 people were selected randomly (using a random number table) since a 20-25% loss to follow up was calculated and the least amount of patients needed were 17. During the study participants applied imiquimod cream 5% (Virosupril ® laboratories Roemmers) in the periocular area during the night, three times a week, on nonconsecutive days, for 12 weeks (3 months). If patients presented irritative dermatitis a topical 0.05% desonide cream was administered and applied for less of 5 days until symptoms improved.

Also known as: Virosupril®

imiquimod use in photoaging

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with Fitzpatrick's skin types I to IV, with a photoaging equal to or greater than 3 on the Glogau measuring scale, who had not used systemic retinoids for over four weeks during six months prior to baseline,
• Patients nor had they undergone chemical peels or used exfoliants or applied botulinum toxin or any other abrasive substance on the face six months prior baseline
• patients that had not used topical retinoids or steroids two months prior to baseline
• patients that had not undergone facial rejuvenation surgery 12 months prior to treatment.

You may not qualify if:

• pregnant or nursing women
• patients currently being treated with phototherapy
• patients currently being treated with photochemotherapy or whom were scheduled to start
• patients with suspected skin cancer assessed by clinical examination
• patients with dermatological conditions with changes in the texture or color of the skin
• Patients with inflammatory dermatoses, immunological, infectious, or neoplastic skin diseases located in the periocular area since it could interfere with the clinical assessment of photoaging.

Sponsors & Collaborators

• CES University: lead

Study Sites (1)

Centro de servicios CES Sabaneta

Medellín, Antioquia, 050021, Colombia

Location

Related Publications (19)

• Giacomoni PU, Declercq L, Hellemans L, Maes D. Aging of human skin: review of a mechanistic model and first experimental data. IUBMB Life. 2000 Apr;49(4):259-63. doi: 10.1080/15216540050033104.

  PMID: 10995026 BACKGROUND

• Glogau RG. Physiologic and structural changes associated with aging skin. Dermatol Clin. 1997 Oct;15(4):555-9. doi: 10.1016/s0733-8635(05)70465-4.

  PMID: 9348456 BACKGROUND

• Fisher GJ, Wang ZQ, Datta SC, Varani J, Kang S, Voorhees JJ. Pathophysiology of premature skin aging induced by ultraviolet light. N Engl J Med. 1997 Nov 13;337(20):1419-28. doi: 10.1056/NEJM199711133372003.

  PMID: 9358139 BACKGROUND

• Quan T, He T, Kang S, Voorhees JJ, Fisher GJ. Solar ultraviolet irradiation reduces collagen in photoaged human skin by blocking transforming growth factor-beta type II receptor/Smad signaling. Am J Pathol. 2004 Sep;165(3):741-51. doi: 10.1016/s0002-9440(10)63337-8.

  PMID: 15331399 BACKGROUND

• Fisher GJ, Talwar HS, Lin J, Voorhees JJ. Molecular mechanisms of photoaging in human skin in vivo and their prevention by all-trans retinoic acid. Photochem Photobiol. 1999 Feb;69(2):154-7. doi: 10.1562/0031-8655(1999)0692.3.co;2.

  PMID: 10048311 BACKGROUND

• Rabe JH, Mamelak AJ, McElgunn PJ, Morison WL, Sauder DN. Photoaging: mechanisms and repair. J Am Acad Dermatol. 2006 Jul;55(1):1-19. doi: 10.1016/j.jaad.2005.05.010.

  PMID: 16781287 BACKGROUND

• Metcalf S, Crowson AN, Naylor M, Haque R, Cornelison R. Imiquimod as an antiaging agent. J Am Acad Dermatol. 2007 Mar;56(3):422-5. doi: 10.1016/j.jaad.2006.10.034. Epub 2006 Dec 20.

  PMID: 17184874 BACKGROUND

• Ohnishi Y, Tajima S, Akiyama M, Ishibashi A, Kobayashi R, Horii I. Expression of elastin-related proteins and matrix metalloproteinases in actinic elastosis of sun-damaged skin. Arch Dermatol Res. 2000 Jan;292(1):27-31. doi: 10.1007/pl00007457.

  PMID: 10664012 BACKGROUND

• Weinstein GD, Nigra TP, Pochi PE, Savin RC, Allan A, Benik K, Jeffes E, Lufrano L, Thorne EG. Topical tretinoin for treatment of photodamaged skin. A multicenter study. Arch Dermatol. 1991 May;127(5):659-65.

  PMID: 2024983 BACKGROUND

• Kang SS, Kauls LS, Gaspari AA. Toll-like receptors: applications to dermatologic disease. J Am Acad Dermatol. 2006 Jun;54(6):951-83; quiz 983-6. doi: 10.1016/j.jaad.2005.05.004.

  PMID: 16713451 BACKGROUND

• Dockrell DH, Kinghorn GR. Imiquimod and resiquimod as novel immunomodulators. J Antimicrob Chemother. 2001 Dec;48(6):751-5. doi: 10.1093/jac/48.6.751.

  PMID: 11733457 BACKGROUND

• Sauder DN, Mofid MZ. Topical immunotherapy: what's new. Dermatol Clin. 2005 Apr;23(2):245-58. doi: 10.1016/j.det.2004.08.002.

  PMID: 15837154 BACKGROUND

• Schon M, Schon MP. The antitumoral mode of action of imiquimod and other imidazoquinolines. Curr Med Chem. 2007;14(6):681-7. doi: 10.2174/092986707780059625.

  PMID: 17346155 BACKGROUND

• Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Immune-mediated changes in actinic keratosis following topical treatment with imiquimod 5% cream. J Transl Med. 2007 Jan 26;5:7. doi: 10.1186/1479-5876-5-7.

  PMID: 17257431 BACKGROUND

• McInturff JE, Modlin RL, Kim J. The role of toll-like receptors in the pathogenesis and treatment of dermatological disease. J Invest Dermatol. 2005 Jul;125(1):1-8. doi: 10.1111/j.0022-202X.2004.23459.x.

  PMID: 15982296 BACKGROUND

• Jobanputra KS, Rajpal AV, Nagpur NG. Imiquimod. Indian J Dermatol Venereol Leprol. 2006 Nov-Dec;72(6):466-9. doi: 10.4103/0378-6323.29352. No abstract available.

  PMID: 17179631 BACKGROUND

• Smith K, Hamza S, Germain M, Skelton H. Does imiquimod histologically rejuvenate ultraviolet radiation-damaged skin? Dermatol Surg. 2007 Dec;33(12):1419-28; discussion 1428-9. doi: 10.1111/j.1524-4725.2007.33311.x.

  PMID: 18076606 BACKGROUND

• Szeimies RM, Gerritsen MJ, Gupta G, Ortonne JP, Serresi S, Bichel J, Lee JH, Fox TL, Alomar A. Imiquimod 5% cream for the treatment of actinic keratosis: results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology. J Am Acad Dermatol. 2004 Oct;51(4):547-55. doi: 10.1016/j.jaad.2004.02.022.

  PMID: 15389189 BACKGROUND

• Berneburg M, Plettenberg H, Krutmann J. Photoaging of human skin. Photodermatol Photoimmunol Photomed. 2000 Dec;16(6):239-44. doi: 10.1034/j.1600-0781.2000.160601.x.

  PMID: 11132125 RESULT

MeSH Terms

Interventions

Imiquimod

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sol Beatriz Jiménez, MD

  CES University

  STUDY DIRECTOR

• Lucía Salinas, MD

  CES University

  PRINCIPAL INVESTIGATOR

• Ana Cristina Ruíz, MD

  CES University

  PRINCIPAL INVESTIGATOR

• Natalia De la Calle, MD

  CES University

  PRINCIPAL INVESTIGATOR

• María Alejandra Zuluaga, MD

  CES University

  PRINCIPAL INVESTIGATOR

• Rubén Darío Manrique, PhC

  CES University

  PRINCIPAL INVESTIGATOR

• Bibiana Castro, MSc

  CES University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: September 5, 2013
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: August 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2013-08

Locations

CO (1)